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Stimwave Tech wins CE Mark for SandShark neurostim anchor system
Stimwave Technologies  won CE Mark approval for its SandShark percutaneous injectable anchor system designed to be used in conjunction with its wireless neurostimulator devices to treat chronic pain, according to its distributor Freedom Neuro BV. The SandShark anchor system is designed to affix the neurostimulator device once the stimulator has been injected. The system slides down over the device and presses the anchor into the tissue, where it is secured to the stimulator and the stimulator is secured to surrounding tissue to prevent migration. “A wireless system that enables clinicians to actually have the fu...
Source: Mass Device - May 26, 2017 Category: Medical Devices Authors: Fink Densford Tags: Neuromodulation/Neurostimulation Regulatory/Compliance Stimwave Technologies Source Type: news

Tactile Systems launches Flexitouch lymphedema device
Tactile Systems Technology said today it launched its Flexitouch device designed to treat lymphedema of the head and neck, touting it as the 1st and only pneumatic compression therapy approved for the condition. The Flexitouch device is designed to use pneumatic compression to stimulate the lymphatic system to deliver non-invasive, self-delivered therapy for lymphedema, which is a common result of head and neck cancer and their treatments, the Minneapolis, Minn.-based company said.   “We are thrilled with these positive results demonstrating that the Flexitouch system can help head and neck lymphedema patie...
Source: Mass Device - May 26, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Oncology Pain Management Tactile Systems Technology Source Type: news

Roche launches Accu-Check Guide blood glucose meter
Roche (PINK:RHHBY) this week said it launched the Accu-Chek Guide System blood glucose meter. The company said that the Accu-Chek Guide meter is designed to help simplify diabetes management, featuring a spill-resistant test-strip vial, a large blood application area and strip ports for checks at different times during the day. The Accu-Chek Guide System is designed to automatically track results through its Accu-Chek connect diabetes management application, eliminating the need for self-recording of readings, Roche said in a press release. “Living with diabetes can be challenging and complicated which is why we...
Source: Mass Device - May 26, 2017 Category: Medical Devices Authors: Fink Densford Tags: Diabetes Roche Diabetes Care Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 26, 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. MRI Interventions raises $13.3m in private placement MRI Interventions inked a definitive securities purchase agreement today with a group of investors that is slated to bring the company $13.3 million in gross proceeds. The ag...
Source: Mass Device - May 26, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

New FDA head Gottlieb lifts hiring freeze
Newly assigned FDA commissioner Scott Gottlieb is lifting the hiring freeze enacted in January by the Trump Administration, according to a new report. The announcement was made at the hearing of the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, according to an S&P Global Market Intelligence report. In April, the Trump administration said it would end the hiring freeze at agencies who created plans outlining workforce reductions and cost savings by June 30. Gottlieb said that the FDA was moving forward and beginning to fill vacancies, which h...
Source: Mass Device - May 26, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Food & Drug Administration (FDA) Source Type: news

Presbia touts preliminary data from Microlens PMA trial
Presbia (NSDQ:LENS) this week reported preliminary data from a US pivotal clinical trial of its Flexivue Microlens, touting that over 80% of subjects had shown significant improvements in vision. The Ireland-based company said it is 27 months into the 3-year trial which it hopes will support US FDA Premarket Approval, and that so far, 100% of subjects in the trial have completed their 18 month post-op visit. The company’s lens is intended to correct presbyopia, farsightedness that is often age-related. Presbia’s custom lenses are implanted in the patient’s non-dominant eye in the hopes of&n...
Source: Mass Device - May 26, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Optical/Ophthalmic Presbia Source Type: news

MRI Interventions raises $13.3m in private placement
MRI Interventions (OTC:MRIC) inked a definitive securities purchase agreement today with a group of investors that is slated to bring the company $13.3 million in gross proceeds. The agreement includes 6.6 million aggregate units of common stock and warrants. For each unit purchased, investors will get 1 share of common stock and a warrant to purchase 1 share of stock, according to the agreement. Investors agreed to pay a negotiated price of $2.00 per unit, according to MRI Interventions, and the warrants’ exercise price is $2.20 apiece. The warrants are exercisable for 5 years beginning on the date of issuance....
Source: Mass Device - May 26, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Funding Roundup Imaging Wall Street Beat MRI Interventions Source Type: news

7 medtech stories we missed this week: May 26, 2017
[Image from unsplash.com]From Merck’s new licensing agreement to surgical study data being touted, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Merck inks exclusive licensing agreement for Alzheimer’s antibody Merck announced in a May 25 press release that it has entered an exclusive worldwide license agreement with Teijin Pharma. The licensing agreement is going to help with the development, manufacture and commercialization of an investigation preclinical antibody candidate that targets the protein tau. Merck will have exclusive worldwide rights to develop, manufa...
Source: Mass Device - May 26, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Patient Monitoring Pharma Pharmaceuticals Research & Development Surgical EarlySense Janssen Pharmaceuticals Life Spine Inc. Masimo MedTech Merck Midmark Procept BioRobotics Shenzhen Lachesis Mhealth Teijin Pharma Thermi Source Type: news

Anika launches late-stage supplemental Cingal study
Anika Therapeutics (NSDQ:ANIK) said yesterday that it enrolled the 1st patient in a supplemental Phase III efficacy and safety trial of its Cingal hyaluronic acid-corticosteroid combination viscosupplement. The Bedford, Mass.-bsaed company is evaluating Cingal as a treatment for osteoarthritis-related knee pain. Get the full story at our sister site, Drug Delivery Business News. The post Anika launches late-stage supplemental Cingal study appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - May 26, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Orthopedics Pharmaceuticals Regenerative Medicine Wall Street Beat Anika Therapeutics Inc. Source Type: news

Sectra goes direct in Canada
Sectra (STO:SECTB) said today that it’s establishing a direct sales force in Canada for its medical imaging and cybersecurity offerings. The Swedish company said the move will allow it to focus on the specific needs of the market north of the border, from a base in Toronto that’s expected to go live before September. “To expand in the Canadian market is part of our long-term growth plan. Canada has some unique healthcare challenges that we are prepared to address with our flexible and intuitive software. Sectra has highly-satisfied customers in Canada, but we still have a relatively small market...
Source: Mass Device - May 26, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Imaging Wall Street Beat Sectra Source Type: news

SteadyMed raises another $5m from key shareholder
SteadyMed (NSDQ:STDY) said today that 1 of its largest institutional shareholders exercised warrants to purchase additional shares of the company that the investor got in conjunction with the 1st tranche of a previous private placement. Thanks to the exercise, San Ramon, Calif.-based SteadyMed received an additional $5 million in proceeds. Get the full story at our sister site, Drug Delivery Business News. The post SteadyMed raises another $5m from key shareholder appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - May 26, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Funding Roundup Pharmaceuticals Wall Street Beat SteadyMed Therapeutics Source Type: news

Senseonics prices $41m underwritten offering for Eversense CGM
Senseonics (NYSE:SENS) said today that it priced an underwritten offering of 29 million shares of common stock at $1.41 apiece to a group of institutional investors. Roche Finance agreed to purchase 21 million shares and New Enterprise Associates agreed to purchase 7 million shares in the offering, according to the Germantown, Md.-based company. Senseonics said it expects to bring in $41 million from the offering, which is slated to close on June 1st. Get the full story at our sister site, Drug Delivery Business News. The post Senseonics prices $41m underwritten offering for Eversense CGM appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - May 26, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Funding Roundup Research & Development Wall Street Beat Source Type: news

Senate GOP to write new healthcare bill during recess
Senate Republicans, said to be dispirited over their party’s failure to enact its own version of healthcare reform despite holding the White House and both chambers of Congress, reportedly plan to write their own healthcare legislation over the Memorial Day recess. Budget committee chairman Sen. Mike Enzi (R-Wyo.), along with Sens. Lamar Alexander (R-Tenn.) and Orrin Hatch (R-Utah), have already begun drafting the Senate’s healthcare bill, Politico reported. “Over the break, initial legislation will be drafted and then we’ll have more time, actually have a basis to discuss” specific polic...
Source: Mass Device - May 26, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Healthcare Reform Capitol Hill Source Type: news

Survey: Medical device makers expect to be hacked but few are doing anything about it
More than ⅔ of medical device makers believe their products are vulnerable to cyberattack, but less than ⅕ are taking significant steps to do anything about it, according to a survey funded by software firm Synopsys. Mountain View, Calif.-based Synopsys paid for cybersecurity think tank company Ponemon Institute to survey people who “have a role or involvement in the assessment of and contribution to the security of medical devices.” Ponemon researchers polled 242 medical device employees and 262 workers at healthcare providers for the report, “Medical Device Security: An Industry Under Attack an...
Source: Mass Device - May 26, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Software / IT Cybersecurity/Hacking ponemoninstitute synopsys Source Type: news

FDA Commissioner asks staff for ‘more forceful steps’ to stem the opioid crisis
This study also found that the longer a person’s first exposure to opioids, the greater the risk that he or she will continue using opioids after one, or even three years. For example, when a person’s first exposure to opioids increases from one day to 30 days, that person’s likelihood of continuing to use opioids after one year increases from 6% to about 35%. Working together, we need to do all we can to get ahead of this crisis. That’s why we’ll also be soliciting public input, through various forums, on what additional steps FDA should consider. I look forward to working closely with my FDA...
Source: Mass Device - May 26, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog FDA Voice Source Type: news

Sanuwave Health taps Lithomed as Taiwanese ortho distributor
Sanuwave Health (OTC:SNWV) said today it tapped Lithomed as its orthopedic product distributor in Taiwan. Suwanee, Ga.-based Sanuwave said the selection of Lithomed was the result of an extensive search in the region, and that the contract comes with a minimum order value of $500,000. “Sanuwave has committed to deliver 3-5 new distribution partners in the second quarter and 7-10 by the end of the year. This is the first step in achieving or beating our target. We are also excited to be able to support our science advisor Dr. Chin-Jen Wang, Professor of Orthopedic Surgery at Chang Gung Memorial Hos...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Fink Densford Tags: Distribution Orthopedics SANUWAVE Health Inc. Source Type: news

Mauna Kea touts data from Cellvizio lung transplant study
This study provides further evidence of the broad potential of the Cellvizio platform to improve diagnostic and treatment outcomes. We thank Dr. Keller and his colleagues for conducting this unique study sponsored by Mauna Kea Technologies and demonstrating that with proper training, the procedure is effective and reproducible. We are optimistic that Cellvizio will increasingly be used in a variety of applications that can benefit from its unique ability to provide real-time diagnostic information at the cellular level. Moreover, image interpretation automation with artificial intelligence will contribute to the performanc...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Imaging Mauna Kea Technologies Source Type: news

NovaBone launches bioactive bone graft substitutes
NovaBone Products added NovaBone IRM and IRM MacroPOR to its portfolio of biologically active bone graft substitutes today. The Jacksonville, Fla.-based company touted its devices as the industry’s most advanced bioactive synthetic bone graft substitutes available for orthopedic applications. The 2 new formulations are highly irrigation resistant and promote osteogenesis and osteoblastic activity, according to NovaBone. Get the full story at our sister site, Drug Delivery Business News. The post NovaBone launches bioactive bone graft substitutes appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Orthopedics Regenerative Medicine Surgical Wall Street Beat NovaBone Source Type: news

2 paths to success on the medtech fundraising trail
Funding a medical technology company isn’t a simple job: Modern medical devices require cutting-edge innovation, research and design to make it to the market. And don’t even get started on regulatory and reimbursement challenges. The recession of the late 2000s, Affordable Care Act and changes to regulatory bodies and reimbursement requirements have changed the game for medical device startups seeking funding. More than ever, young companies need clear paths to avoid running out of money. Read the whole story at our sister site, Medical Design & Outsourcing The post 2 paths to success on the medtech fundr...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Source Type: news

Viveve lands $30m credit facility
Viveve (NSDQ:VIVE) said today it entered a $30 million senior credit facility with affiliates of CRG LP, looking to retire its existing credit facility and acquire additional capital. The facility consists of $20 million to be drawn at closing with the ability to access additional funding up to an aggregate of $10 million, the Sunnyvale, Calif.-based company said. A total of $30 million will be available based on achievement of revenue and market cap milestones through June 30, 2018. “The support and confidence of a well-respected firm like CRG represents another level of validation for our global business and c...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Women's Health Viveve Medical Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 25, 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. Artificial pancreas: These companies are racing to make one Medical device companies are close to achieving the holy grail of diabetes treatment: a combined glucose sensor, control algorithm and insulin infusion device that eff...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Colorectal cancer patients treated with SIR-spheres more likely to be candidates for resection
Treatment with Sirtex Medical‘s (ASX:SRX) Y-90 resin microspheres and chemotherapy was associated with a statistically significant gain in potentially curative liver resectability, according to data published earlier this week. The results come 1 week after the Australian company reported that its radioactive microspheres had no effect in improving survival in patients with colorectal cancer in its Foxfire analysis. Get the full story at our sister site, Drug Delivery Business News. The post Colorectal cancer patients treated with SIR-spheres more likely to be candidates for resection appeared first on MassDevic...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Oncology Pharmaceuticals Surgical Wall Street Beat Sirtex Medical Source Type: news

Medical imaging AI dev Viz raises $8m in seed round
Medical imaging artificial intelligence company Viz said today it closed a $7.5 million seed round of financing to support the development of its AI platform. Viz is developing an AI-equipped medical imaging platform with an initial focus on stroke, looking to improve outcomes and treatment of stroke patients by shortening the time between seeking and receiving treatment. The company’s AI platform is being developed to compare patient scans to thousands of other scans to determine patterns within them, and aid in treatment accuracy and speed. “As doctors, there is nothing more important to us than improving pat...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Software / IT viz Source Type: news

Ex-Stryker rep loses appeal of $750k loss
A former Stryker (NYSE:SYK) sales rep yesterday lost his appeal of a nearly $750,000 loss in a lawsuit over his move to rival Biomet (now Zimmer Biomet (NYSE:ZBH)). Stryker in 2013 sued Christopher Ridgeway and another sales agent, Richard Steitzer, accusing them of scheming to poach reps and business from Stryker in Louisiana and New York. Stryker fired Ridgeway in September 2013, after discovering that he was allegedly running a pair of medical supply businesses on the side. In June of that year, Stryker alleged, Biomet began courting Ridgeway, looking to bring his entire Stryker sales teams on b...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Orthopedics Stryker zimmerbiomet Source Type: news

Study: Radiation may boost immunotherapy in mesothelioma treatment
Doctors in Pennsylvania reported this week that combining immunotherapy drugs with radiotherapy could help to more efficiently treat malignant pleural mesothelioma. The analysis from the University of Pennsylvania looked at studies that combined immunotherapy drugs like Merck‘s (NYSE:MRK) Keytruda with radiation therapy. The team concluded that radiotherapy may boost the cancer-killing effects of immunotherapies. Get the full story at our sister site, Drug Delivery Business News. The post Study: Radiation may boost immunotherapy in mesothelioma treatment appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Oncology Pharmaceuticals Research & Development Respiratory Merck Source Type: news

Artificial intelligence accurately predicts stroke risk
[Image from unsplash.com]Machine-learning algorithms, a form of artificial intelligence, accurately predicted people’s risk of heart disease and stroke, according to new research from the University of Nottingham. Researchers and computer scientists compared the risk guidelines for heart disease and stroke from the American College of Cardiology with 4 machine-learning algorithms to analyze the risk of a patient having each. The results showed that the artificially intelligent algorithms were significantly more accurate at predicting cardiovascular disease than the regular medical models. Get the full story on our si...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Research & Development AI artificial intelligence cardiovascular disease heart disease machine learning algorithms Stroke University of Nottingham Source Type: news

Acelity launches Prevena Duo NPWT system in US
Acelity said today it launched its Prevena Duo incision management system in the US. The Prevena Duo is a single use negative pressure wound therapy system specifically designed for the simultaneous management of 2 closed surgical incisions, the San Antonio, Texas-based company said, claiming it is the 1st such product of it’s kind. The system is designed to reduce post-operative complications in bilateral procedures, including vascular harvesting, breast reconstruction and orthopedic trauma surgeries. “SSIs encompass more than 20 percent of all HAIs and represent a significant burden both financially...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wound Care Acelity Source Type: news

FDA chief: Changing generics regulations could reel in drug prices
Part of the FDA commissioner’s job is to oversee the federal regulatory watchdog as it evaluates pharmaceuticals for safety and efficacy. Most FDA chiefs have avoided the topic of drug prices, given that it isn’t a clearly-stated part of the agency’s mission But just 2 weeks into the job, newly-confirmed FDA commish Dr. Scott Gottlieb proposed a plan, called the Drug Competition Action Plan, that he believes will help restrain the cost of prescription drugs. Get the full story at our sister site, Drug Delivery Business News. The post FDA chief: Changing generics regulations could reel in drug prices ...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Healthcare Reform Pharmaceuticals Regulatory/Compliance Wall Street Beat Mylan Source Type: news

Patient safety pioneer Dr. Amy Reed dies at 44
The physician who helped put an end to the 18-year gap between the FDA’s approval of laparoscopic power morcellators and the safety watchdog learning that the devices can spread malignant cancers in the abdomen, Dr. Amy Reed, died yesterday of leiomyosarcoma, according to news reports. She was 44. Power morcellators use small, rotating blades to break up large tissue masses into fragments and are commonly used to remove benign uterine fibroids in women. But if the device is used on a patient with undetected cancer, it can strew cancerous cells throughout the abdomen. Although the FDA approved morcellat...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Women's Health Source Type: news

J & J ’ s Ethicon touts economic analysis data in Dermabond Prineo studies
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon today released the results from 2 economic analysis of its Dermabond Prineo skin closure system, touting improved patient outcomes and lower healthcare costs. The Dermabond Prineo skin closure system combines topical skin adhesive with a self-adhering patch, the company said. Data from the economic analyses of the system were presented at the International Society for Pharmacoeconomics and Outcomes Research’s 22nd annual international meeting this week. The 1st study compared economic and clinical outcomes between the use of the Dermabond Prineo system and...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Surgical Wound Care Ethicon Johnson & Johnson Source Type: news

9 diabetes breakthroughs you need to know
[Image from PracticalCures on Flickr]Diabetes is a disease that affects the body’s ability to produce and respond to insulin. About 29.1 million people have diabetes in the U.S, according to the Centers for Disease Control and Prevention. Of that number, 8.1 million go undiagnosed. One of the most popular breakthroughs in diabetes research has been the artificial pancreas, which is a closed-loop insulin delivery system that doubles as a glucose monitor. But there are more breakthroughs going on now, too. From artificial pancreases to tricking beta cells into regenerating, here are 9 diabetes breakthroughs you should ...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Diabetes Diagnostics Research & Development Afrezza Apple beta cells insulin MedTech Source Type: news

Artificial pancreas: These companies are racing to make one
Medical device companies are close to achieving the holy grail of diabetes treatment: a combined glucose sensor, control algorithm and insulin infusion device that effectively acts as an “artificial pancreas.” We explain more in the newest video from editors at MassDevice’s sister publication Medical Design & Outsourcing. (And for a deeper dive, check out our recent roundup of companies in the race.) The post Artificial pancreas: These companies are racing to make one appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Diabetes Drug Pumps Drug-Device Combinations mHealth (Mobile Health) admetsys Animas Artificial pancreas Beta Bionics Bigfoot Biomedical Defymed Dexcom Insulet MedTech Medtronic Semma Therapeutics Tandem Diabetes Care TypeZ Source Type: news

Ultrasound-drug combo treats pulmonary embolism in less time with fewer drugs
When venous clots break off and travel through a patient’s circulatory system, they can become trapped in the lung and block blood flow. This strains the heart’s ability to pump blood through the lungs and can ultimately lead to heart failure. Traditionally, patients with pulmonary embolisms are treated overnight with systemic infusions of tissue plasminogen activator. But, according to Dr. Victor Tapson at Cedars-Sinai Medical Center in Los Angeles, large doses of tPA are associated with side effects including intracranial bleeding and smaller doses can be safer and just as effective as the larger, c...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Pharmaceuticals Vascular Wall Street Beat BTG Source Type: news

BioCorRx to meet with the FDA for injectable, sustained-release opioid addiction therapy
BioCorRx (OTC:BICX) said today that the FDA has granted the anti-addiction developer a pre-investigational new drug meeting, scheduled for Sept. 19. The Anaheim, Calif.-based company said it is slated to review the development and marketing plan for BICX101, an injectable, sustained-release formulation of naltrexone as a therapy for opioid addiction and alcohol use disorders. Get the full story at our sister site, Drug Delivery Business News. The post BioCorRx to meet with the FDA for injectable, sustained-release opioid addiction therapy appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat BioCorRx Source Type: news

Australia mulls green-lighting overseas-approved devices
Australia’s Therapeutic Goods Administration this week proposed to allow the marketing of medical devices that already won approval in certain other jurisdictions. Under the proposal, devices approved by authorities in countries that are part of the International Medical Device Regulators Forum would be allowed onto the TGA’s Register of Therapeutic Goods. In addition to Australia and the U.S., the IMDRF’s members are Brazil, Canada, China, Europe, Japan, Russia and Singapore. “The Government has decided that the TGA should make greater use of marketing approvals for devices in overseas markets when...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Regulatory/Compliance Australia Therapeutic Goods Administration Source Type: news

Medtronic beats The Street with fiscal Q4, 2017 results
Medtronic (NYSE:MDT) posted sales and earnings that topped Wall Street’s estimates for its fiscal 4th quarter and 2017, as its full-year bottom line grew nearly 14% on sales growth of 3%. The world’s largest medical device company reported profits of $1.16 billion, or 84¢ per share, on sales of $7.92 billion for the 3 months ended April 28, amounting to profit growth of 5.3% and sales growth of 4.6% compared with Q4 2016. Adjusted to exclude 1-time items, earnings per share were $1.33, 2¢ ahead of The Street, where analysts were looking for sales of $7.86 billion. Full-year profits were $4.03 billion,...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat Medtronic Source Type: news

CBO: Trumpcare bill cuts deficit, but millions would lose insurance
An estimated 23 million people would lose their health insurance by 2026 under Republican legislation to repeal and replace Obamacare, according to a non-partisan Congressional Budget Office report released yesterday. The CBO said that the so-called “Trumpcare” bill, which narrowly passed by U.S. House earlier this month, would also reduce federal deficits by $119 billion between 2017 and 2026. The bill would cover an additional 1 million Americans than a previous version of the bill, which failed to clear the House, according to the CBO. In their scoring of the previous version, the budget ...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Fink Densford Tags: Healthcare Reform Capitol Hill Source Type: news

Invacare to layoff 50 in NA region
Invacare (NYSE:IVC) said today it will reduce its workforce in North America by approximately 50 individuals. The Elyria, Ohio-based company said it expects to pay approximately $700,000 in charges related to the layoffs, expected to be expensed in its 2nd quarter of 2017. Invacare said it expects that the workforce reduction will generate approximately $2.7 million in annualized pre-tax savings, according to an SEC filing. “Our transformation emphasizes quality, patient centric solutions, streamlined customer engagements and reduced costs. We remain focused on improving profitability and managing cash flow to s...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Invacare Source Type: news

CBO scores Trumpcare bill, estimates 23 million lose insurance by 2026
An estimated 23 million people would lose health coverage by 2026 under Republican legislation, dubbed Trumpcare, according to the non-partisan Congressional Budget Office report released today. The Office said that the bill, which was narrowly passed by the US House earlier this month and looks to begin dismantling and repealing Obamacare, would also reduce federal deficits by $119 billion between 2017 and 2026 The bill would cover an additional 1 million more Americans than a previous version of the bill which failed to pass the House, according to the CBO. In their scoring of the previous version, the Office said t...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Fink Densford Tags: Healthcare Reform Capitol Hill Source Type: news

Gore wins Japanese regulatory nod for Gore Excluder IBE
W.L. Gore & Associates said today it won Japanese regulatory approval for its Gore Excluder iliac branch endoprosthesis and that the 1st implants of the device had been performed in the region. The Newark, Del.-based company said that the Excluder IBE was the 1st off-the-shelf iliac branch solution approved in the country, and the only device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. “Providing a simple and straightforward procedure, the IBE preserves flow to the internal iliac arteries during EVAR. In many patients, it is imperative that iliac artery ...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Stent Grafts Vascular W.L. Gore & Associates Source Type: news

Torax Medical touts preliminary results from Linx GERD study
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon‘s Torax Medical business today released results from the Caliber trial of its Linx system for treating gastro-esophageal reflux disease, touting quality of life improvements and reduction in reflux levels. The Linx system is an implant composed of interlinked titanium beads with magnetic cores that augments the esophageal sphincter’s barrier function to prevent reflux in patients with gastro-esophageal reflux disease, the company said. Data from the trial was presented at the Digestive Disease Week 2017 meeting in Chicago. The randomized, controlled, 150-patie...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Otolaryngology Ear, Nose & Throat Ethicon Johnson & Johnson Torax Medical Inc. Source Type: news

Neural Analytics touts 95% accuracy for TCD platform in Expedite trial
Neural Analytics today released initial results from the Expedite study of its Transcranial Doppler Tech platform, touting 95% accuracy in the early detection of acute ischemic stroke due to large vessel occlusion. Data from the study was presented at the 26th annual European Stroke Conference this week in Berlin. The 45-subject trial examined the use of TCD scans in patients experiencing computer tomography angiography confirmed acute ischemic stroke due to large vessel occlusion of the internal carotid artery or middle cerebral artery. Scans with the TCD platform were analyzed with 2 different stroke assessment algo...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Diagnostics Neurological Ultrasound Neural Analytics Source Type: news

Liquidia touts Phase I data for sustained-release post-surgical pain reliever
Liquidia Technologies touted initial data from its LIQ865 Phase I trial, which evaluated its sustained-delivery formulation of bupivacaine for post-surgical pain relief. The trial was the 1st evaluation of the company’s formulation in humans. Researchers assessed the safety, pharmacokinetic profile and pharmacodynamic response of a single-ascending dose in healthy adult males. Get the full story at our sister site, Drug Delivery Business News. The post Liquidia touts Phase I data for sustained-release post-surgical pain reliever appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Pain Management Pharmaceuticals Surgical Liquidia Technologies Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 24, 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. Feds charge ex-Medicare employees with insider trading Former employees at the Centers for Medicare & Medicaid Services used confidential information on Medicare reimbursement changes for radiation treatments and dialysis i...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Theraclion touts Echopulse data from thyroid nodules studies
Theraclion (EPA:ALTHE) touted data today from 3 studies evaluating the use of Echopulse as a non-invasive treatment for benign thyroid nodules. One of the studies was the 1st direct comparison of echotherapy to surgery. The study, which was published in the International Journal of Hyperthermia, compared 43 patients who were treated with Theraclion’s Echopulse, an ultrasound-guided high-intensity focused ultrasound system, to 103 patients who underwent hemithyroidectomy. Patients who were treated with the French company’s system experienced significantly lower incidence of subclinical hypoth...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Surgical Ultrasound Theraclion Source Type: news

FDA approves 1st cancer drug based on genetics, not tissue type
In a landmark decision, the FDA approved Merck‘s (NYSE:MRK) immunotherapy Keytruda yesterday as the 1st cancer treatment indicated for any solid tumor with a specific genetic feature, regardless of tissue type. Traditionally, the location where a cancer originates in a patient’s body determines the course of treatment. The move to treat cancers based on genetic biomarkers is a nod towards precision medicine, which physicians hope will help identify patients that are most likely to respond to specific therapies. Get the full story at our sister site, Drug Delivery Business News. The post FDA approves 1...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Oncology Pharmaceuticals Wall Street Beat Merck Source Type: news

LivaNova snags former J & J exec Huston as CFO | Personnel Moves, May 24, 2017
LivaNova (NSDQ:LIVN) said last week that it picked up former Johnson & Johnson medical device group chief financial officer Thad Huston as its new CFO, effective May 20. Huston will replace former CFO Vivid Sehgal, who coordinated with Huston during the transition. Huston spent more than 25 years with Johnson & Johnson, and held various positions, including prez of its Xian-Janssen Pharmaceuticals division in China, finance VP and CFO & COO for its pharmaceutical R&D and finance VP and CFO for its Ortho-McNeil Pharma division. “I am eager to join the exceptional team at LivaNova. We share a passi...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Alcon Brainlab Cardiovascular Systems Inc. Fortimedix LivaNova Nativis Novartis sightlife Stimwave Technologies Teleflex Vuzix Source Type: news

Feds charge ex-Medicare employees with insider trading
Former employees at the Centers for Medicare & Medicaid Services used confidential information on Medicare reimbursement changes for radiation treatments and dialysis in a nearly $4 million insider trading scheme, federal prosecutors and the U.S. Securities & Exchange Commission alleged today. An SEC lawsuit and a criminal complaint accuse political consultant David Blaszczak, founder of Precipio Health Strategies and the one-time colleague at CMS of Christopher Worrall, of feeding inside information on the rate changes from Worrall through Blaszczak to traders at Deerfield Management. The traders &n...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Wall Street Beat DaVita Inc. Elekta AB Fresenius Insider Trading Varian Medical Systems Source Type: news

Medtronic launches study of In.Pact Admiral drug-coated balloon in end-stage renal disease
Medtronic (NYSE:MDT) said today that the 1st patient was enrolled in a study of its In.Pact Admiral drug-coated balloon in patients with end-stage renal disease. The FDA approved the investigational device exemption study to evaluate the device as a treatment for failing arteriovenous fistulas in end-stage renal disease patients. Get the full story at our sister site, Drug Delivery Business News. The post Medtronic launches study of In.Pact Admiral drug-coated balloon in end-stage renal disease appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Vascular Wall Street Beat Medtronic Source Type: news

Boston Scientific ’ s post-approval Alair study shows long-term asthma improvement
Patients treated with the Alair device made by Boston Scientific (NYSE:BSX) showed long-term improvement in controlling their asthma, according to a post-approval study released today at the annual meeting of the American Thoracic Society in Washington. The Alair bronchial thermoplasty treatment uses a bronchoscope to deliver radiofrequency energy to reduce the amount of excess smooth muscle tissue in the airways. Boston acquired the technology when it paid $194 million in cash for Asthmatx in 2010, shortly after that company won 510(k) clearance from the FDA for Alair. The deal also included some $250 million in pote...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Respiratory Wall Street Beat Boston Scientific Source Type: news