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Lombard Medical CEO Hubbert, CFO Kullback step down | Personnel Moves, April 28, 2017
Lombard Medical Technologies (NSDQ:EVAR) said this month that its CEO Simon Hubbert and CFO William Kullback are stepping down from their positions, with Kurt Lemvigh stepping into the CEO role. Hubbert served as CEO for 6 years after joining the company in 2010, and will be replaced by Lemvigh, who has held positions with multiple companies, including Cardiac Science and GE (NYSE:GE). “Lombard represents a unique opportunity given the strength of the company’s portfolio in the over $1.5 billion market for endovascular repair products. The key to success will be our ability to leverage the work that has been don...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Accuray Inc. Becton Dickinson & Co. Boston Scientific Cardiac Sciences Corp. ConMed Corp. Fresenius GE Healthcare Lombard Medical Technologies Magnolia Medical Technologies ReWalk Robotics Senseonics Toshiba Source Type: news

Mentor launches breast implant warranty program
Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide said today it launched the MentorPromise Protection Plan, a new comprehensive warranty program for all Mentor breast implants sold in the US. The San Diego, Calif.-based company said that all Mentor breast implant recipients will be automatically enrolled in the plan, with an enhanced version of the plan available for an extra fee. “When you have a warranty program as strong as the MentorPromise Protection Plan, it makes choosing Mentor products an easy decision. Mentor’s confidence in their products reassures me that I am working with quality prod...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cosmetic/Aesthetic Women's Health Johnson & Johnson Mentor Worldwide Source Type: news

Accuracy shares dip on Q3 miss
Shares in Accuray (NSDQ:ARAY)  dropped slightly today after the medical device maker missed expectations on Wall Street with its fiscal 3rd quarter results. The Sunnyvale, Calif.-based company posted losses of $5 million, or 6¢ per share, on sales of $97.3 million for the 3 months ended March 31, seeing the bottom-line swing into losses from reported profits of $756,000 while sales shrunk 7.6% compared with the same period last year. Accuray posted losses per share that just missed Wall Street consensus of 0¢.  Revenue also fell short of expectations of $110.2 million. “Our 49% year-over-year gross order growth ...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Accuray Inc. Source Type: news

Carl Zeiss joins ASML in patent countersuit against Nikon over lithography tech
European semiconductor manufacturer ASML and its strategic partner Carl Zeiss (ETR:AFX) today filed a patent infringement countersuit against Nikon (TYO:7731) in response to legal action taken by Nikon against the companies. The suits involve semiconductor manufacturing equipment, flat panel display manufacturing equipment and digital cameras. On Monday, Nikon filed its own patent case against ASML and Zeiss accusing them of using its lithography technology without permission. ASML denies any infringement and said there was no choice but to file countersuits. “Now that Nikon has decided to take this dispute to cour...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Legal News Carl Zeiss Meditec Nikon Source Type: news

Wireless power source could enable ingestible drug delivery devices
Image: MIT News. Battery image courtesy of Ella Maru Studio / Giovanni Traverso / Abubakar Abid Researchers from the Massachusetts Institute of Technology, Brigham and Women’s Hospital and the Charles Stark Draper Laboratory have developed the means to wirelessly power electronic devices that stay in the digestive tract indefinitely. The team suggests that these devices could be used as sensors in the GI tract or carry drugs to be delivered over a controlled period of time. An efficient power source is a crucial part of developing ingestible electronic devices and that has previously stumped researchers. “If we’re pr...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Research & Development Brigham & Women's Hospital Draper Laboratories Massachusetts Institute of Technology Source Type: news

7 medtech stories we missed this week: April 28, 2017
[Image from unsplash.com]From FDA and Health Canada approvals to joint ventures, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Joimax Endovapor 2 Joimax announced in an April 26 press release that it has received FDA 510(k) clearance to market its Endovapor 2 Multi-Radio Frequency System. The device generates electricity for monopoly and bipolar cutting and coagulation of tissue structures in surgery. It has programs designed for spinal cord surgery with an interdisciplinary application. It also has 2 monopolar and 2 bipolar sockets with an easy touchpad technology. ...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Food & Drug Administration (FDA) News Well Surgical Anaconda Biomed Creganna Medical Eclipse Aesthetics Joimax Mederi Therapeutics MedTech Millennium Medical Technologies SiBone Theraclion Source Type: news

Report: NAFTA renegotiations could spell trouble for US medtech industry
The North American Free Trade Agreement may not be facing the gallows after the Trump administration this week said it does not plan to terminate it – but changes to the deal could have a huge impact on the medical device industry, according to a New York Times report. This week, Trump spoke with Mexican Pres. Enrique Peña Nieto and Canadian Prime Minister Justin Trudeau and said he would start the process or renegotiating the deal, despite previous promises to eliminate it, according to the report. Medical device manufacturers were identified as a particularly vulnerable sector to renegotiation in the report, as t...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News integer-holdings Medtronic North American Free Trade Agreement (NAFTA) Source Type: news

H & T Presspart, Hovione ink commercialization deal for inhaler tech
H&T Presspart said this week that it acquired the global rights to Hovione Technology‘s capsule-based dry powder inhaler. The company launched a next-gen version of the inhaler called PowdAir Plus at this year’s Respiratory Drug Delivery Europe. The PowdAir Plus device is made of plastic and its 4-component design lessens manufacturing, assembly and production costs, according to H&T Presspart. Get the full story at our sister site, Drug Delivery Business News. The post H&T Presspart, Hovione ink commercialization deal for inhaler tech appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Respiratory Wall Street Beat H&T Presspart Hovione Technology Source Type: news

MassDevice.com +5 | The top 5 medtech stories for April 28, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Boston Scientific looks to lead the drug-eluting PAD market Angioplasty is not a new procedure – doctors have been widening obstructed arteries with balloons since the 1960s. But for years the medtech industry has been plague...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Venus Medtech wins Chinese FDA approval for Venus A-valve TAVR
Chinese heart valve maker Venus Medtech said today it won China FDA approval for its Venus A-valve device, touting it as the 1st transcatheter aortic valve implantation device to win CFDA approval. The Venus A-valve device offers a less invasive treatment solution for inoperable and high-risk patients, providing a solution to patients in the region that previously was unavailable, the Hangzhou-based company said. “We have worked hard to get here, and at Venus Medtech, we believe in innovation through solid science. We will continue to help save lives and treat critical cardiovascular diseases at home and abroad. ...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Regulatory/Compliance Replacement Heart Valves Venus Medtech Source Type: news

Straumann inks distro deal, ups stake in Rodo Medical
Dental device developer Rodo Medical said today that it entered into a new distribution agreement with Straumann Holding, which has increased its stake in Rodo Medical from 12% to 30% for an undisclosed sum. The agreement will provide Straumann with exclusive distribution rights outside of North America and South Korea with an option to increase Straumann’s participation to 51% in 2021, San Jose, Calif.-based Rodo Medical said today. “Rodo’s ability to develop a revolutionary concept, turn it into a medical device and bring it to market is impressive. Their entrepreneurial and scientific approach to innov...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Dental Distribution Rodo Medical Straumann Holdings AG Source Type: news

Artificial pancreas shows promise in pediatric study
A pilot study evaluating an artificial pancreas in children with Type I diabetes found that the device helped kids control their condition, according to researchers at the University of Virginia. The artificial pancreas was developed at the UVA Center for Diabetes Technology and features a smartphone powered by algorithms that wirelessly link to a glucose monitor and insulin pump. Get the full story at our sister site, Drug Delivery Business News. The post Artificial pancreas shows promise in pediatric study appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Diabetes Drug-Device Combinations Pediatrics Research & Development University of Virginia Source Type: news

12 interesting wearables you should know
Wearable technology is probably one of those things you probably didn’t need but still wanted because people were always talking about the devices. Fitbit, Apple and Garmin are some of the main providers of health and wellness wearables. Each of them touts being able to track your fitness activity or measures your heart rate. However, consumer wearables are not regulated by the FDA and therefore are not intended to be used as a medical device. Wearables, though, are now coming into their own in medtech, with a bunch of devices going through the regulatory and approval process at FDA. Academic researchers, meanwhile, con...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Biotech Cardiovascular Diabetes mHealth (Mobile Health) Patient Monitoring Research & Development Respiratory Cardiac Insight Devices Hill Rom Klick Labs MedTech Nemaura Medical wearables wireless devices Zoll Medical Corp. Source Type: news

TransEnterix files FDA 510(k) application for Senhance, prices $24.9m round
TransEnterix (NYSE:TRXC) said today that it filed an application with the FDA seeking 510(k) clearance for its Senhance robot-assisted surgery platform and priced a $24.9 million funding round. The application is a huge step forward for the company, CEO Todd Pope told MassDevice.com today in a telephone interview. “The most important milestone that we’ve hit now is that we have filed our FDA 510(k) submission with the FDA, and we wanted to make sure we have enough cash to get all the way through submission, acceptance and a launch here in the U.S.,” Pope told us. Pope said he’s hopeful the company...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Robot-Assisted Surgery Robotics TransEnterix Source Type: news

Sanofi Q1 earnings top estimates, diabetes sales fall
Shares in Sanofi (NYSE:SNY) rose today after the company beat expectations on Wall Street with its 1st quarter results. The French company posted profits of $5.7 billion on sales of $8.65 billion for the 3 months ended March 31, for bottom-line growth of 413.5% on sales growth of 11.2% compared with the same period last year. Get the full story at our sister site, Drug Delivery Business News.   The post Sanofi Q1 earnings top estimates, diabetes sales fall appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: MassDevice Earnings Roundup Pharmaceuticals Wall Street Beat Sanofi-Aventis Source Type: news

Allergan closes $2.4B Zeltiq acquisition
Allergan (NYSE:AGN) said today that it closed its $2.48 billion acquisition of Zeltiq Aesthetics Inc. (NSDQ:ZLTQ) and its portfolio of body-contouring products. Zeltiq’s FDA-approved CoolSculpting system uses a cooling mechanism to reduce the appearance of fat which has not responded to diet or exercise, without disturbing surrounding tissue. Get the full story at our sister site, Drug Delivery Business News. The post Allergan closes $2.4B Zeltiq acquisition appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Mergers & Acquisitions Pharmaceuticals Wall Street Beat Allergan Inc. Zeltiq Source Type: news

Titan Medical spikes talks with Chinese distributor
Titan Medical (CVE:TMD) said today that it’s spiking talks with Chinese distributor Longtai Medical over its Sport robot-assisted surgery platform so it can focus on winning regulatory approvals in the U.S. and Europe. Back in October 2015, Toronto-based Titan inked a private placement deal with Longtai, a subsidiary of Chinese medical device distributor Ningbo Long Hengtai International Trade Co., that could have ended up being worth more than $24 million. Longtai put up a $2 million deposit toward the distribution deal, but now that talks have ended that money must be returned, Titan said. “We are focused...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Distribution Robot-Assisted Surgery Wall Street Beat Titan Medical Inc. Source Type: news

Hill-Rom gains on fiscal Q2 beats
Hill-Rom Holdings (NYSE:HRC) shares are up today after the medical products giant beat Wall Street’s expectations for both sales and earnings during its fiscal 2nd quarter. The Chicago-based company posted profits of $34.4 million, or 51¢ per share, on sales of $678.9 million for the 3 months ended March 31, for a bottom-line gain of 54.3% on sales growth of 7.3% compared with fiscal Q2 2016. Adjusted to exclude 1-time items, earnings per share were 88¢, 9¢ ahead of The Street, where analysts were looking for sales of $655.1 billion. The news pushed HRC shares up 2.8% to $75.89 apiece today in mid-morning trading...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Hospital Care Mergers & Acquisitions Wall Street Beat Hill-Rom Holdings Inc. Source Type: news

Boston Scientific looks to lead the drug-eluting PAD market
Angioplasty is not a new procedure – doctors have been widening obstructed arteries with balloons since the 1960s. But for years the medtech industry has been plagued with what Jeff Mirviss, president of Boston Scientific’s interventional peripheral biz, calls the procedure’s Achilles heel: Restenosis. For patients treated with bare balloons, half must have the procedure done again because their arteries have re-clogged. Stents improved that rate to 1 of every 3 or 4 patients, Mirviss told Drug Delivery Business News. But drug-coated balloons designed to control scar tissue formation can bring the rate down to 1 in...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Drug-Eluting Stents Pharmaceuticals Vascular Boston Scientific Source Type: news

Baxter CEO Almeida: We could do an $7.5B acquistion
Baxter chairman & CEO Joe Almeida says he’s prepared to pull the trigger on a major acquisition worth as much as $7.5 billion, but any deal has to pass the healthcare giant’s M&A criteria. Speaking with analysts earlier this week during a conference call to discuss Deerfield Park, Ill.-based Baxter’s 1st-quarter results, Almeida said that the transformation begun after he took the reins at the beginning of last year puts the company in position to execute a deal. “We’re open to the tuck-ins, and we’re doing them, and we’re working very hard to get even more opportunitie...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Mergers & Acquisitions Wall Street Beat Baxter Source Type: news

Olympus to acquire Image Stream Medical
Olympus (TYO:7733) said today that its American subsidiary plans to acquire Image Stream Medical for an undisclosed amount. Littleton, Mass.-based Image Stream makes software designed to connect hospital imaging equipment and systems. Center Valley, Pa.-based Olympus Corp. of the Americas said it aims to build a global systems integration platform using the Image Stream tech. “We are very happy to welcome Image Stream Medical to the Olympus family,” OCA president & CEO Nacho Abia. “Image Stream Medical is a top tier integration provider that continues to experience consistent market growth on the ...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Hospital Care Imaging Mergers & Acquisitions Wall Street Beat Image Stream Medical Olympus Source Type: news

Johnson & Johnson lands $260m Defense Dept. contract for orthopedic devices
The U.S. Defense Dept. yesterday awarded a Johnson & Johnson (NYSE:JNJ) unit a contract for orthopedic products worth nearly $260.5 million. The 1-year contract with Piscataway, N.J.-based Johnson & Johnson Healthcare System includes 4 1-year options; the total maximum value of the agreement covers the life of the contract including the option years, if exercised, according to the Pentagon. The deal calls for J&J to supply orthopedic products to the Army, Navy, Air Force, Marine Corps and federal civilian agencies. The contract is slated to expire April 27, 2022, the DoD said. The Pentagon also said it gran...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Orthopedics Resuscitation Johnson & Johnson Physio-Control U.S. Defense Dept. Source Type: news

United Therapeutics launches $250m share repurchase program
United Therapeutics (NSDQ:UTHR) said today that its board of directors approved the repurchase of up to $250 million of the biotech’s common stock. The share repurchase program is effective immediately and United said it will stay open until the end of 2017. The company can make purchases in the open market, accelerated share repurchases or in privately negotiated transactions. Get the full story at our sister site, Drug Delivery Business News. The post United Therapeutics launches $250m share repurchase program appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Wall Street Beat United Therapeutics Source Type: news

Medtronic, Abbott could still seek exit from India ’ s high-end stent market
Medtronic (NYSE:MDT) and Abbott (NYSE:ABT) could take another run at taking their high-end stents off the Indian market, after the Indian National Pharmaceutical Pricing Authority this week rejected their applications to withdraw. Earlier this month, Medtronic and Abbott said they would look to withdraw select high-value coronary stents from the Indian market in light of cost caps imposed by the NPPA. Medtronic filed to remove its Resolute Onyx stent from the market, while Abbott filed to remove both its Absorb and Alpine stents. But the NPPA rejected the applications, requesting that the companies consider other op...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Stents Wall Street Beat India Indian National Pharmaceutical Pricing Authority (NPPA) Source Type: news

Align Technology shares rise on Q1 Beat-and-Raise
Align Technology (NSDQ:ALGN) shares have risen significantly in after hours trading today after the orthodontic device maker posted 1st quarter earnings that beat expectations on Wall Street. The San Jose, Calif.-based company posted profits of $69.4 million, or 85¢ per share, on sales of $310.3 million for the 3 months ended March 31, for bottom-line growth of 71.2% while sales grew 30% compared with the same period last year. Align’s earnings per share value handily topped Wall Street expectations of 67¢. Sales also topped consensus on The Street, where analysts expected to see $297.4 million for the quarter. “...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Align Technology Source Type: news

Merit Medical sees shares rise in after hours trading on Street-topping Q1
Shares in Merit Medical (NSDQ:MMSI) have risen in after hours trading today after the medical device maker beat expectations on The Street with its 1st quarter earnings. The South Jordan, Utah-based company posted profits of $14.8 million, or 32¢ per share, on sales of $171.1 million for the 3 months ended March 31, for bottom-line growth of 240.2% while sales grew 23.9% compared with the same period last year. Adjusted to exclude 1-time items, earnings per share were 28¢, well above the 23¢ consensus on The Street, where analysts were looking for sales of $163.9 million. “Our management team is pleased with our p...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Merit Medical Systems Inc. Source Type: news

ResMed Shares dip on Q3 release despite meeting EPS expectations
ResMed (NYSE:RMD) saw shares fall today in after hours trading after the medical device maker posted 3rd quarter earnings that met earnings per share expectations, but fell short on revenue. The San Diego-based company posted profits of $87.8 million, or 62¢ per share, on sales of $514.2 million for the 3 months ended March 31, for negative bottom-line growth of 3.3% while sales grew 13.3% compared with the same period in the previous year. Adjusted to exclude 1-time items, earnings per share were 71¢, just in line with expectations on The Street, where analysts were expecting to see sales of $519.9 million. “We h...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup ResMed Inc. Source Type: news

Medtronic wins Health Canada nod for OsteoCool RF ablation system
Medtronic (NYSE:MDT) said today it won Health Canada approval for its OsteoCool radiofrequency ablation system for treating cancers that metastasize to the spine, and launched the system in the region. The Fridley, Minn.-based company touted the OsteoCool system as the only cooled RF ablation technology with simultaneous, dual-probe capabilities. “Our pain therapies business is deeply rooted in the Medtronic mission – which calls us to alleviate pain. We put an important treatment option into the hands of physicians so they can help more patients suffering from debilitating cancer pain,” Medtronic Canada rest...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Regulatory/Compliance Spinal Medtronic Source Type: news

Integer Holdings schedules Q1 earnings release for May 8
Integer Holdings (NYSE:ITGR)  said last week it will release its 1st quarter earnings on May 8th, scheduled to be released after the market closes. The release will be followed by a conference call with the management of the company, according to a press release. In late March, Integer, which rebranded from Greatbatch last June, said that Thomas Hook was stepping down as president & CEO of the company, with company director Joseph Dziedzic taking over on an interim basis. Hook will stay on the Frisco, Texas-based company’s board until the company’s 2017 annual meeting of stockholders, but will not seek re-el...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup integer-holdings Source Type: news

Tandem misses on Q1 earnings, beats rev estimates
Shares in Tandem Diabetes (NSDQ:TNDM) fell today after the medical device maker missed earnings expectations on Wall Street with its 1st quarter results, but beat revenue estimates. The San Diego-based company posted losses of -$23.8 million, or -75¢ per share, on sales of $18.9 million for the 3 months ended March 31, for bottom-line loss of -13.9% on sales loss of -6% compared with the same period last year. Get the full story at our sister site, Drug Delivery Business News. The post Tandem misses on Q1 earnings, beats rev estimates appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations MassDevice Earnings Roundup Pharmaceuticals Wall Street Beat Tandem Diabetes Care Source Type: news

Galatea Surgical wins FDA 510(k) for GalaForm 3D plastic surgery scaffold
Tepha Inc subsidiary Galatea Surgical said today it won FDA 510(k) clearance for its GalaForm 3D surgical scaffold device designed for use in plastic and reconstructive surgery. The Lexington, Mass.-based company claims that the GalaForm 3D scaffold is the only 3-dimensionally contoured surgical scaffold with a reinforcing rim designed to uplift the body’s shape for easier placement. The device is based on Tepha’s proprietary P4HB bioresorbable polymer tech, the company said. “Scaffolds play an important role in aesthetic surgery, where we deal with rejuvenating weakened tissue. We have studied soft-tissu...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Cosmetic/Aesthetic Food & Drug Administration (FDA) Regulatory/Compliance Galatea Surgical Tepha Inc. Source Type: news

Novartis slapped with $49m fine over kickbacks
South Korea regulators said today that it fined Swiss drugmaker Novartis (NYSE:NVS)$48.8 million for offering doctors kickbacks in exchange for recommending the company’s drugs to patients. The Ministry of Health and Welfare also decided to suspend insurance coverage of 9 variations of 2 drugs, including the Alzheimer’s drug Exelon, for 6 months, according to Reuters. Get the full story at our sister site, Drug Delivery Business News. The post Novartis slapped with $49m fine over kickbacks appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Legal News Pharmaceuticals Regulatory/Compliance Wall Street Beat Novartis Source Type: news

NovoCure shares rise on Q1 EPS beat
Shares in NovoCure (NSDQ:NVCR) rose today after the medical device maker beat losses per share expectations on Wall Street with its 1st quarter earnings results. The St. Helier, Jersey-based company posted losses of $18 million, or 21¢ per share, on sales of $34.9 million for the 3 months ended March 31, seeing bottom-line losses shrink 49.1% while sales grew a massive 167.2% compared with the same period in 2016. Losses per share were ahead of the 24¢ consensus on The Street, while sales fell just short of expectations of $37 million. “Our growth continued in the 1st quarter 2017. It was the ninth consecutive qua...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup NovoCure Source Type: news

MassDevice.com +5 | The top 5 medtech stories for April 27, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Avedro raises $42m, opens new Mass-based manufacturing facility Avedro said today it raised $42 million in equity and debt financing and opened a new manufacturing facility in Burlington, Mass. The equity financing was led by H...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Pendant Bioscience joins J & J JLABS incubator in Toronto
Advanced materials and drug delivery developer Pendant Biosciences said today it won acceptance into Johnson & Johnson (NYSE:JNJ) Innovation’s JLABS incubator in Toronto. Pendant Biosciences is developing a surface coating and drug delivery technologies through a polymer-based platform. The Nashville, Tenn.-based company said it is initially focused on developing applications within the orthopedic market. The company’s lead product candidate is a surface modification intended to reduce risk associated with certain orthopedic transplants, which it said has the potential to operate in multiple therapeutic are...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Research & Development pendant biosciences Source Type: news

Antidepressant could help ferry drugs across blood-brain barrier
Researchers at the National Institutes of Health have found that pairing an antidepressant with neurological drugs can enhance drug delivery to the brain. The team’s research was published online in the Journal of Cerebral Blood Flow and Metabolism. The team cautioned that more work needs to be done to determine if the discovery will hold up in the clinic, but the team’s work could enhance treatment for brain-centered conditions. Traditionally, researchers have trouble fighting neurological diseases with drugs because of the blood-brain barrier – a protective barrier that keeps dangerous compounds out of the brain, ...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Neurological Pharmaceuticals Research & Development National Institutes of Health (NIH) Source Type: news

Bausch & Lomb wins FDA 510(k) for Vitesse open-port vitrectomy system
Valeant Pharmaceuticals (NYSE:VRX, TSE:VRX) subsidiary Bausch & Lomb said today it won FDA 510(k) clearance for its Vitesse hypersonic open port vitrectomy system. The Bridgewater, N.J.-based company touted the newly cleared system as the 1st and only hypersonic 100% open port vitrectomy system, and said it will be exclusively available on the Stellaris Elite vision enhancement system. “I feel privileged to have been able to work with Bausch + Lomb in the development of this new technology since its birth in the lab in 2012. This is perhaps the first major technological change in the way we remove the vitreous s...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Optical/Ophthalmic Regulatory/Compliance Bausch Lomb Valeant Pharmaceuticals Source Type: news

FDA approves J & J ’ s Mentor MemoryGel Xtra silicone breast implants
Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide said today it won FDA approval for its MemoryGel Xtra silicone gel-filled breast implants. With the approval, Mentor said it also launched an Artoura breast tissue expander designed to work with the newly cleared MemoryGel Xtra implants. The Artoura breast tissue expander features a smooth shell to provide controlled expansion for reconstructive surgeries. “Since its launch in 2015, the Mentor Artoura expander platform has proven to be a welcome innovation in breast tissue expander technology. Having a new smooth shell configuration, in addition to the e...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cosmetic/Aesthetic Food & Drug Administration (FDA) Women's Health Johnson & Johnson Source Type: news

Nordisk wins label update for weight loss drug-device combo
Novo Nordisk (NYSE:NVO) said today that the FDA approved an updated label for its Saxenda liraglutide weight loss medicine. The therapy’s new label will include data showing that half of patients who received Saxenda and lost at least 5% of their weight after 56 weeks maintained their weight loss for 3 years. The update is based on data from the company’s Scale obesity and pre-diabetes 3-year trial, which evaluated the long-term safety and efficacy of Saxenda in 3,731 adults. Get the full story at our sister site, Drug Delivery Business News. The post Nordisk wins label update for weight loss drug-device combo appeare...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Novo Nordisk Source Type: news

UPDATE: Integra Lifesciences shares down on Q1 release
Updated to correct the company who filed the report – previously identified Integer Holdings. Shares in Integra LifeSciences (NSDQ:IART) fell today slightly after the medical device maker posted 1st quarter earnings that met expectations on Wall Street. The Plainsboro, N.J.-based company posted profits of $6.4 million, or 8¢ per share, on sales of $258.6 million for the 3 months ended March 31, for a bottom-line slide of 52.4% while sales grew 9.2% compared with the same period last year. After adjusting to exclude 1-time items, earnings per share were 39¢, meeting the 39¢ consensus on The Street, where analysts...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Integra LifeSciences Corp. Source Type: news

Contego Medical wins CE Mark for Vanguard IEP angioplasty system
Contego Medical said today it won CE Mark approval in the European Union for its Vanguard IEP periperhal balloon angioplasty system and launched the device in the region. The newly cleared Vanguard IEP system incorporates a peripheral angioplasty balloon and distal embolic filter on a single catheter, the Raleigh, N.C.-based company said. The system has an over-the-wire design with a sheathless integrated 150-micron pore filter distal for the angioplasty balloon. “The Vanguard IEP System is an important step toward enhancing safety for patients undergoing peripheral angioplasty for occlusive disease. This device wil...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Regulatory/Compliance Vascular Contego Medical Source Type: news

Avedro raises $42m, opens new Mass-based manufacturing facility
Avedro said today it raised $42 million in equity and debt financing and opened a new manufacturing facility in Burlington, Mass. The equity financing was led by HealthQuest Capital and joined by OrbiMed Advisors and InterWest Partners, while the debt financing was supported by an affiliate of OrbiMed, the company said. “Avedro has established itself as the global leader in corneal cross-linking technology, particularly in the areas of progressive keratoconus and corneal ectasia following refractive surgery. We value our partnership with Avedro and are happy to support their growth, as well as their ongoing efforts...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Avedro Inc. Source Type: news

Surgical robots: Hospital CTO talks differentiators in new crop of competitors
For the last 10 years, if anyone mentioned robotic surgery or surgical robots, 95 percent of the time they meant the da Vinci robot from Intuitive Surgical. “That product has been so dominantly successful that almost everybody who talks about it is talking with that as their reference point,” said Roger Smith, chief technology officer for Florida Hospital Nicholson Center. Smith’s primary work involves researching the effectiveness of surgical robots. Smith said that in the last several years, a few surgical robot companies have come onto the scene and are vying for market share. In the realm of abdominal or thoraci...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Heather Thompson Tags: Blog Devices Intuitive Surgical laparoscopy Medical Device Business Medical Equipment medical robotics minimally invasive Robotic Systems surgical robotics TransEnterix Source Type: news

Midazolam nasal spray trial meets primary endpoint in patients with seizure clusters
Proximagen Ltd. said today that its pivotal Phase III trial of intranasal midazolam met its primary efficacy endpoint as a treatment for patients with seizure clusters. The Cambridge-based company said it plans to begin talks with the FDA for a New Drug Application in the 2nd half of this year based on the trial’s findings. The company’s USL261 formulation was developed for intranasal delivery in patients who require control of intermittent bouts of heightened seizure activity. Get the full story at our sister site, Drug Delivery Business News. The post Midazolam nasal spray trial meets primary endpoint in pati...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Neurological Proximagen Source Type: news

Critic questions FDA ’s handling of Essure product complaints
FDA continues to update how it is informing the public about the controversial Essure permanent birth control device from Bayer. But at least one prominent critic sees holes in FDA’s efforts. “Many women are still being implanted with the device without adequate warnings of the risks associated with the device,” attorney Holly Ennis wrote in an April 20 blog post. Essure is a small metal coil that is implanted in the fallopian tubes via catheter. In 2015, FDA reported that in the 13 years since Essure’s approval, the agency had received 5,093 complaints, including for pain or menstrual irregularities after usi...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Heather Thompson Tags: Blog Bayer Essure FDA Implantables Medical Device Business permanent birth control postmarket Regulatory Source Type: news

BREAKING: Senate panel approves FDA nominee Gottlieb
A U.S. Senate panel voted today to approve Dr. Scott Gottlieb to lead the FDA, sending his nomination to the full Upper Chamber for a confirmation vote. The Senate Health, Education, Labor & Pensions Committee approved Gottlieb on a 14-9 vote. The full Senate is also expected to approve the nomination. Gottlieb, 44, is a former FDA deputy commissioner who has advocated a loosening of requirements needed for approval of new medical products. He is also a resident fellow at the conservative American Enterprise Institute think tank, a partner at venture capital firm New Enterprise Assoc., and sits on the boards of mult...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Wall Street Beat Capitol Hill Source Type: news

Acorda misses on Q1 earnings, slashes expense guidance after restructuring
Shares in Acorda Therapeutics (NSDQ:ACOR) fell today after the biopharmaceutical company missed expectations on Wall Street with its 1st quarter results. The Ardsley, N.Y.-based company posted a net loss of -$18.9 million, or -41¢ per share, on sales of $119.4 million for the 3 months ended March 31. In the same quarter last year, Acorda reported a net loss of -$0.5 million on sales of $115.9 million. Get the full story at our sister site, Drug Delivery Business News. The post Acorda misses on Q1 earnings, slashes expense guidance after restructuring appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: MassDevice Earnings Roundup Neurological Pharmaceuticals Wall Street Beat Acorda Therapeutics Source Type: news

Zimmer Biomet slides on lowered outlook, despite Q1 beats
Zimmer Biomet (NYSE:ZBH) shares are off today after the orthopedics giant beat Wall Street’s 1st-quarter forecast but lowered its outlook for the rest of the year. Warsaw, Ind.-based Zimmer Biomet posted profits of $299.4 million, or $1.47 per share, on sales of $1.98 billion for the 3 months ended March 31, for bottom-line growth of 175.2% on sales growth of 3.8% compared with Q1 2016. Adjusted to exclude 1-time items, earnings per share were $2.13, 2¢ ahead of The Street, where analysts were looking for sales of $1.96 billion. But the company also lowered its guidance for the rest of the year, saying it now exp...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: MassDevice Earnings Roundup Orthopedics Wall Street Beat Zimmer Biomet Source Type: news

Braeburn ’s risperidone implant meets primary endpoint in schizophrenia trial
Braeburn Pharmaceuticals said yesterday that a 6-month study of its risperidone implant in patients with schizophrenia or schizoaffective disorder met its primary endpoint. Risperidone, the most commonly-prescribed therapy for schizophrenia, depends on consistent administration, but patients with schizophrenia sometimes stop taking their medication when their symptoms improve. Long-acting, injectable formulations of risperidone are on the market, but there is no FDA-approved formulation that lasts for 6-months, according to Braeburn. Get the full story at our sister site, Drug Delivery Business News. The post Braeburn’...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Implants Neurological Pharmaceuticals Wall Street Beat Braeburn Pharmaceuticals Source Type: news

SurModics misses on Q2 earnings, narrows outlook
Shares in SurModics (NSDQ:SRDX) fell today after the medical device maker missed earnings expectations on Wall Street with its 2nd quarter results and narrowed its full-year outlook. The Eden Prairie, Minn.-based company posted profits of $506,000, or 4¢ per share, on sales of $17.5 million for the 3 months ended March 31, for bottom-line loss of -38% on sales growth of 5% compared with the same period last year. Get the full story at our sister site, Drug Delivery Business News. The post SurModics misses on Q2 earnings, narrows outlook appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations MassDevice Earnings Roundup Wall Street Beat SurModics Inc. Source Type: news