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SA biotech incubator doesn ’t have to travel far to strike new deal with medical device maker
Watershed Idea Foundry and Nvision Biomedical Technologies have struck a new partnership here at home that addresses new FDA hurdles. (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - September 26, 2017 Category: Health Management Authors: W. Scott Bailey Source Type: news

How Artificial Intelligence Could Save Healthcare
They say the only two certainties in life are death and taxes, but you could also make an argument for adding rising healthcare costs to the list. “There is no end in sight to the amount of healthcare spending because it scales with multiple on the population,” Josh Makower, MD, general partner venture capital firm New Enterprise Associates (one of the top 10 medtech VC firms), told an audience at the Medtech Conference in San Jose yesterday. Speaking on a panel about the future of healthcare delivery at the event hosted by medtech industry trade group AdvaMed, Makower went on to assert that medical devices and...
Source: MDDI - September 26, 2017 Category: Medical Devices Authors: Jamie Hartford Tags: Medical Device Business Source Type: news

FDA Gives Spectranetics ’ Recall Class I Status
FDA has decided that Spectranetics’ recent recall of its Bridge Occlusion Balloon Catheter deserves Class I status. The company sent an urgent letter to customers and distributors in August to alert them of a recall involving the Bridge Occlusion Balloon Catheter after nine customers complained about blocked guidewire lumens. Spectranetics said none of the compromised devices caused any serious injury to the patient, but the company’s inspection revealed that the frequency of a potentially blocked guidewire lumen is about 10%. If a device with a compromised guidewire lumen were to be used, the company said...
Source: MDDI - September 26, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Regulatory and Compliance Source Type: news

Advamed CEO Whitaker optimistic for device tax repeal this year.
The 2.3% medical device tax imposed as part of the Affordable Care Act has a good chance of being repealed this year, according to an optimistic AdvaMed CEO Scott Whitaker. In a press conference at AdvaMed’s Medtech conference in San Jose today, Whitaker was positive about the chances of the tax being repealed, and laid out 3 specific policy focuses for the industry group for the future: tax policy, regulatory changes and CMS payment issues. Whitaker presented options for a repeal of the tax, assuming that the current attempts to repeal and replace the ACA fall through. These include a must-sign legislation later thi...
Source: Mass Device - September 26, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Food & Drug Administration (FDA) AdvaMed AdvaMed 2017 medicaldevicetax Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 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. EY is upbeat about the medical device industry: Here’s why The medical device industry is growing, at a healthy and steady pace. This is according to EY’s Pulse of the Industry report, which was released today at Ad...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Spectranetics Corp Recalls Bridge Occlusion Balloon Catheter Risk Blcked Guidewire Lumen Prevent Balloon Utilization https://go.usa.gov/xRSXD  
Spectranetics Corp Recalls Bridge Occlusion Balloon Catheter Risk Blcked Guidewire Lumen Prevent Balloon Utilization https://go.usa.gov/xRSXD  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 25, 2017 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA seeking to prevent medical device shortages from hurricanes
[Image courtesy of NOAA]The U.S. FDA has been seeking to prevent shortages of medical devices and other products after disruptions caused by Hurricanes Harvey, Irma and Maria. “These storms have hit hard in areas where there are a significant number of farmers, food distributors, and medical product manufacturers, including Houston, Florida, and now Puerto Rico and the U.S. Virgin Islands,” Dr. Scott Gottlieb, the FDA’s commissioner, said in a Sept. 22 announcement. “Thankfully, to date, no critical shortages have been identified in areas impacted by Harvey and Irma,” Gottlieb said. “The...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Food & Drug Administration (FDA) Hurricane Maria Source Type: news

Edwards Lifesciences has ‘ key events ’ around TAVR this week
Edwards Lifesciences is planning some important TAVR reveals during the PCR London Valves 2017 course that is underway. The Irvine, Calif.–based cardio devices company said yesterday that it plans to introduce the new Sapien 3 Ultra valve during the event, which runs until tomorrow. Edwards officials expect the Sapien 3 Ultra to receive CE Mark by the end of the year, with plans for a U.S. introduction in late 2018. For the Ultra, they’ve added a taller skirt to the Sapien 3 design to improve TAVR outcomes, according to the company. Edwards has incorporated the taller skirt initially with sizes 20, 23 and ...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Cardiovascular Catheters Clinical Trials Edwards Lifesciences tavr Source Type: news

EY, Evaluate are upbeat about the medical device industry: Here ’ s why
[Image from unsplash.com]The medical device industry is growing at a healthy and steady pace, according to new reports that EY and Evaluate released today during AdvaMed’s annual Medtech Conference. “The results of this year’s report is a direct contrast to last year and tells a positive story about the future of the medtech industry,” said EY partner Arda Ural. According to EY’s “Pulse of the Industry” report, the global medical technology (medtech) industry grew by 5% in 2016, a pace last seen before the financial crisis. This strong performance was fueled by mergers and acquisit...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: Heather Thompson Tags: Business/Financial News AdvaMed AdvaMed 2017 Ernst & Young Evaluate EY Source Type: news

Turning Deadlines into Finish Lines
Facing fierce market competition and increasingly rapid technological change, medical device manufacturers are under constant pressure to innovate—and quickly. Companies face long, expensive product development cycles involving many stakeholders, internal reviews, design updates, validations, regulatory approvals, and more. During these product development cycles, timelines often shift—but critical deadlines do not. In this fast-paced environment, there is a real need for partners who can expedite the launch of highly-complex, critical parts while holding a firm commitment to the quality and standards needed in...
Source: MDDI - September 25, 2017 Category: Medical Devices Authors: Darren Bjork Tags: Contract Manufacturing Source Type: news

#FDA provides update on risks associated with SynCardia TAH-t: C2 & Freedom Driver Systems #MedicalDevices https://go.usa.gov/xRSTk  
#FDA provides update on risks associated with SynCardia TAH-t: C2 & Freedom Driver Systems #MedicalDevices https://go.usa.gov/xRSTk  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 25, 2017 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Shandong Weigao to pay $850m for Argon Medical Devices
Shandong Weigao Group Medical Polymer agreed to pay $850 million for Argon Medical Devices, as the Chinese company looks to expand its footprint overseas. Weigao Group, which makes medical devices, orthopedic and blood purification products, is trying to fill out its product portfolio and diversify its revenue stream, according to a filing with the Hong Kong Stock Exchange. The company said it expects “significant growth opportunities” for Argon Medical’s products in China, according to the filing. Plano, Texas-based Argon Medical makes single-use speciality medical devices for biopsy, vascular ...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Wall Street Beat Argon Medical Devices Inc. Shandong Weigao Group Medical Polymer Source Type: news

Abbott Catches Up to Peers With MRI-Compatible ICD
Abbott Laboratories acquired St. Jude Medical earlier this year knowing that the company trailed behind its peers in the cardiac rhythm management (CRM) space by not having a MRI-compatible pacemaker or implantable cardioverter defibrillator (ICD) system. It seems Abbott has officially caught up in that category though, first with FDA approval of the Assurity MRI pacemaker and the Tendril MRI pacing lead during the first quarter, and now with FDA approval of MRI-conditional labeling for the Ellipse ICD system. Abbott said the recent approval covers one of its most widely-used ICD systems and associated high voltage leads. ...
Source: MDDI - September 23, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis Labeling Business Source Type: news

Smiths Group shares fall on missed forecast
Smiths Medical parent company Smiths Group (LON:SMIN) saw shares fall more than 5% today after reporting a fall in underlying full-year revenue due to weaknesses in its medical device unit and energy equipment and service businesses. The fall made the company the worst performer on the London Stock Exchange’s FTSE 100 Index today. Smiths Medical was faced with delays in its new product releases, seeing revenues decline 3% for the year at $1.28 billion (GBP £951 million), while analysts on Wall Street expected to see revenues of $1.3 billion (GBP £962 million). Overall, the company’s revenu...
Source: Mass Device - September 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Smiths Group plc Smiths Medical Source Type: news

7 medtech stories we missed this week: Sept. 22, 2017
[Image from unsplash.com]From the FDA’s clearance of Covalon’s film-drape to Bioventus launching its study, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Covalon’s MediClear OTC surgical film-drape Covalon announced in a Sept. 21 press release that the FDA has cleared its MediClear PreOp to market in U.S. hospitals, clinic and directly to patients without a prescription. The MediClear PreOp is a breathable, transparent, self-adhesive, silicone barrier film-drape that can conform to a patient’s skin at a planned incision or insertion si...
Source: Mass Device - September 22, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Business/Financial News Diagnostics Food & Drug Administration (FDA) Laboratory Instruments/Laboratory Supplies mHealth (Mobile Health) Research & Development Vascular Bioventus LLC Contego Medical Covalon Technologies Getinge Guerbe Source Type: news

MicroPort < sup > ® < /sup > Hosts Ninth Aortic Intervention International Forum
(Source: Microport News Release)
Source: Microport News Release - September 22, 2017 Category: Medical Devices Source Type: news

Have You Considered the Potential of Deep Design?
How much time do medical product designers spend on understanding clinical processes? Perhaps not enough. Product designers “often don’t see their devices as part of a system,” says Kathleen Harder, PhD, director of the Center for Design in Health at the University of Minnesota. But there can be adverse ripple effects with devices, she warns. Harder also serves as director of graduate studies in the Human Factors Program at University of Minnesota. For more than 15 years, she has worked with clinicians to test ideas that guide users toward desired behaviors in healthcare delivery. With a background as an ...
Source: MDDI - September 22, 2017 Category: Medical Devices Authors: Daphne Allen Tags: R & D Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 22, 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. 5 DeviceTalks Boston exhibitors you should know DeviceTalks Boston is an annual event that allows some of the best minds in medtech to exchange ideas, insights and technologies. The event is hosted by MassDevice. Those who atte...
Source: Mass Device - September 22, 2017 Category: Medical Devices Authors: MassDevice Tags: Blog Plus 5 Source Type: news

Five DeviceTalks Boston exhibitors you should know
DeviceTalks Boston is an annual event that allows some of the best minds in medtech to exchange ideas, insights and technologies. The event is hosted by MassDevice. Those who attend the event can expect to network with other medtech enthusiasts, attend in-depth interviews with leaders in the industry and panel discussions about medical devices and the medtech industry. The event also houses dozens of exhibitors who will be showcasing some of their hot technologies and services at the event. Here are five exhibitors at DeviceTalks Boston this year that you should know about. Next>> The post Five DeviceTalks Boston exh...
Source: Mass Device - September 22, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Business/Financial News cyient DeviceTalks Boston globalpriorart jordilabs MedTech MPR Toxikon Source Type: news

Abbott wins MR-conditional label for Ellipse ICDs
Abbott (NYSE:ABT) said today that it won an MR-conditional label from the FDA for the Ellipse implantable cardioverter defibrillator it acquired along with St. Jude Medical early this year. The MR-conditional label applies to Ellipse and the Tendril MRI pacing lead and the Durata and Optisure high-voltage leads, the Chicago-area medical device giant said. “When you consider the number of patients each year who rely on the lifesaving treatment delivered by an ICD device, it is critical to continually innovate to provide new benefits to people battling complex arrhythmias and other cardiac conditions,” cardiac ar...
Source: Mass Device - September 22, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Food & Drug Administration (FDA) Imaging Regulatory/Compliance Abbott Cardiac Rhythm Management Source Type: news

Federal Workers Who Made a Difference
The federal government gets a bad rap: it is constantly described as bloated and clunky, its workers as inefficient and ineffectual. Yet by and large, the men and women who make up the federal workforce rise above the criticism, put one foot in front of the other and do their job. Rarely is the work they do acknowledged, much less praised. But for the past 16 years, the Samuel J. Heyman Service to America Medals, or Sammies, have sought to change that by honoring federal employees who have an outsize impact on the country and the world. Below, the 2017 Sammie winners, chosen by the nonpartisan Partnership for Public Servic...
Source: TIME.com: Top Science and Health Stories - September 22, 2017 Category: Consumer Health News Authors: Maya Rhodan Tags: Uncategorized Government Source Type: news

NuVasive acquires startup with Duke University roots
Vertera Spine, a startup with research origins at Duke University and the Georgia Institute of Technology, has been acquired by San Diego-based medical device company NuVasive (Nasdaq: NUVA), which reported revenues of more than $960 million last year. Ken Gall, chair of Duke’s Department of Mechanical Engineering and Materials Science, co-founded Vertera in 2013 while working as a professor at Georgia Tech. “NuVasive will use this to really dominate the market,” he says. “What we liked… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 22, 2017 Category: Biotechnology Authors: Jennifer Henderson Source Type: news

FDA clarifies if microneedling should be classified as a medical device
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have published new guidance clarifying how they determine if microneedling products used for skin treatments qualify as medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. The post FDA clarifies if microneedling should be classified as a medical device appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - September 22, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

More Than $500K in Prizes on the Line for Four Startups
It’s down to just four companies in the 2017 MedTech Innovator $500K Competition, whittled down from a field of almost 600 companies. The finalists, which emerged from the 20-company MedTech Innovator Accelerator, will vie for the top prize next week. Representatives from each company will pitch to an audience and judging panel during a session at The MedTech Conference in San Jose, CA on September 26. The panel of judges, which includes leaders from Johnson & Johnson, Baxter Ventures, Becton Dickinson, and Kaiser Permanente Ventures, will ask questions before the session audience casts their votes. The medical t...
Source: MDDI - September 22, 2017 Category: Medical Devices Authors: Marie Thibault Tags: Medical Device Business Source Type: news

MicroPort < sup > ® < /sup > Orthopedics Hosts 2017 Asia Pacific Didactic Meeting
(Source: Microport News Release)
Source: Microport News Release - September 22, 2017 Category: Medical Devices Source Type: news

MicroPort ® Orthopedics Hosts Satellite Meeting in CAS 2017
(Source: Microport News Release)
Source: Microport News Release - September 22, 2017 Category: Medical Devices Source Type: news

MicroPort < sup > ® < /sup > Orthopedics Holds Medial Pivot Knee Roadshow
(Source: Microport News Release)
Source: Microport News Release - September 22, 2017 Category: Medical Devices Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 21, 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. This sweat-powered biofuel cell could create better wearable devices Engineers at the University of California at San Diego have created a stretchable sweat-powered biofuel cell, and it could enable better wearables. The biofue...
Source: Mass Device - September 21, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

FDA chimes in on off-label use, preemption in Smith & Nephew hip suit
The FDA last week chimed in on a lawsuit brought against Smith & Nephew (NYSE:SNN) by a patient whose surgeon used the company’s hip implants off label, arguing that federal law preempts most tort claims even when medical devices are used outside of their indications. Plaintiff Walter Shuker was implanted with components from Smith & Nephew’s 510(k)-cleared R3 acetabular system and an R3 metal liner in April 2009 (confusingly, the R3 liner was granted pre-market approval as part of the company’s Birmingham hip resurfacing system and was not intended or approved for use with the R3 acetabular ...
Source: Mass Device - September 21, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Legal News Product Liability metal-on-metal hips Smith & Nephew Source Type: news

Medical device firm moving HQ into City Garage manufacturing accelerator
An Annapolis medical technology company is moving its headquarters to The LaunchPort, a device manufacturing accelerator set to be housed at the City Garage startup hub in Port Covington. Vixiar Medical Inc., a spinout of Johns Hopkins, is developing non-invasive devices and systems for monitoring cardiopulmonary diseases. The company recently raised a $1.5 million seed round to prepare for commercial launch of its first product. Investors include the Abell Foundation and Maryland Technology Development… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 21, 2017 Category: Pharmaceuticals Authors: Morgan Eichensehr Source Type: news

Indian gov ’ t mulls price cap on ‘ essential ’ medical devices
The Indian government is considering capping prices on medical devices it deems essential to health care, according to a new report from LiveMint. The government has assembled a committee to create a National List of Essential Medical Devices which it intends to make available with assurances related to both quality and price, according to the report. “The devices and medical equipment included under the list will be those which are required for the basic running of medical premises including hospitals, clinics and those required to handle medical emergency,” a government document stated, according to LiveMint&...
Source: Mass Device - September 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Regulatory/Compliance Indian National Pharmaceutical Pricing Authority (NPPA) Source Type: news

FDA Releases Cefaly(R) for Acute Treatment of Migraine Attacks
NEW YORK, Sept. 21, 2017 -- (Healthcare Sales & Marketing Network) -- CEFALY Technology announces today that on Friday, September 15th, the U.S. Food and Drug Administration (FDA) released the use of a new Cefaly® medical device for the acute treatmen... Devices, Neurology, FDA CEFALY Technology, trigeminal nerve stimulation, e-TNS, migraine (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 21, 2017 Category: Pharmaceuticals Source Type: news

South Korean regulators change new medical device regulations
By Stewart Eisenhart, Emergo Group The South Korean Ministry of Food and Drug Safety (MFDS) have made updates to two significant medical device regulations that came into force earlier in 2017, and published one draft update as well. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. The post South Korean regulators change new medical device regulations appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - September 21, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

Can You Help Prevent These Insulin-Delivery Errors?
New consensus-based guidelines may inspire ideas to curb errors.   Insulin is considered a high-alert medication because it is often associated with significant patient harm when used in error.  “According to a 2014 survey of pharmacists and nurses conducted by the Institute for Safe Medication Practices (ISMP), IV insulin ranked first and subcutaneous insulin ranked ninth among nearly 40 drugs and drug classes identified as high-alert medications that concerned practitioners,” Susan F. Paparella, RN, MSN, vice president, ISMP, told MD+DI. “Yet of all the high-alert medications, subcut...
Source: MDDI - September 21, 2017 Category: Medical Devices Authors: Daphne Allen Tags: Medical Device Business Source Type: news

AMRI Assembles a Comprehensive Medical Device Expert Solutions Team
Our in-depth expertise and extensive portfolio of services provide end-to-end medical device testing and validation solutions to tackle the challenges faced by medical device manufacturers.(PRWeb September 21, 2017)Read the full story at http://www.prweb.com/releases/2017/09/prweb14720612.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - September 21, 2017 Category: Pharmaceuticals Source Type: news

Did NuVasive Investors Miss the Writing on the Wall?
When NuVasive shocked Wall Street in late July by announcing that two of its top executives were leaving the company, analysts ultimately concluded that the changes were unexpected but would not be all that disruptive to NuVasive’s day-to-day business. Now, a report from short-seller GlassHouse Research suggests there is more to the turnover than meets the eye. GlassHouse said the abrupt departure of former Chief Operating Officer Jason Hannon and Chief Financial Officer Quentin Blackford indicates that the clock may be running out for NuVasive, and that the company has been fooling investors with accounting tricks. ...
Source: MDDI - September 20, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis Medical Device Business Orthopedics Source Type: news

UPDATE: Hurricane Maria poses threat to med device hub in Puerto Rico, Medtronic closes facilities
[Image courtesy of NOAA]Updated to include information on a Medtronic facility closure. Hurricane Maria is posing a threat to medical device and pharmaceutical manufacturing plants in Puerto Rico, according to a new Bloomberg report. The island is home to facilities for Johnson & Johnson (NYSE:JNJ), Pfizer (NYSE:PFE), Amgen (NSDQ:AMGN), Merck, Medtronic (NYSE:MDT) , Abbott (NYSE:ABT), Stryker (NYSE:SYK) and dozens of others, according to the report. Most of the companies created facilities in Puerto Rico due to tax incentives, Bloomberg reports. The storm...
Source: Mass Device - September 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blog Business/Financial News Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 20, 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. The 10 largest medical device companies in the world Mergers & acquisitions continue to change the medical device landscape, as reflected in Medical Design & Outsourcing’s new Big 100 list. We pulled financial reg...
Source: Mass Device - September 20, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Update from the Dean - September 2017
Strategic plan progress report. Research: Driving the development of innovative and precise drugs, medical devices, and diagnostic tests. Flu treatments; Tackling antimalarial resistance; Attacking hard targets; Plotting cell maps; Safer opioid pain killer; Cellular construction; New products through bioengineering; Regulatory science leadership; Tobacco burden in vulnerable populations; Economics of disease; Precision medicine. Education: Preparing leaders who think critically, work across fields, and lead in rapidly changing marketplaces.... (Source: UCSF School of Pharmacy News)
Source: UCSF School of Pharmacy News - September 20, 2017 Category: Universities & Medical Training Authors: Paula Joyce Source Type: news

The 10 largest medical device companies in the world
Mergers & acquisitions continue to change the medical device landscape, as reflected in Medical Design & Outsourcing’s new Big 100 list. We pulled financial regulatory filings and reached out to major companies in some cases to create a list of the 100 largest medical device companies in the world, ranked by annual revenue for their medical device operations. Yesterday, we counted down Nos. 20–11. Today, it’s the top 10. Read on to find out important information about medtech’s largest companies. Download the full Big 100 list here. And you can also pick up a free hard copy of the Big 100 is...
Source: Mass Device - September 20, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Big Data Business/Financial News Big 100 Source Type: news

The 20 largest medical device companies in the world
When it comes to the largest medical device companies, it’s a changing cast of players – as demonstrated once again in Medical Design & Outsourcing’s latest Big 100 list. We pulled financial regulatory filings and reached out to major companies in some cases to create a list of the 100 largest medical device companies in the world, ranked by annual revenue for their medical device operations. Now we’re going to count down the top 20. Some companies are usual suspects, but there are also surprises – especially thanks to the continued frenzy of mergers and acquisitions taking place in the sp...
Source: Mass Device - September 20, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Big Data Business/Financial News Big 100 Source Type: news

NuVasive shares slide on negative note from analyst
UPDATE: Updated to reflect that Cowen & Co. did not downgrade the stock, but issued a negative note. NuVasive Inc. (NSDQ:NUVA) shares dropped over 7% after financial group Cowen & Co. issued a negative note on the company following a report from short seller GlassHouse Research which accused the company of “irregular accounting,” according to a Benzinga report. The short seller’s report claims that the company was using accounting tricks to hide that its organic business is in decline, according to Benzinga, and accuses the company of inflating its earnings and growth numbers. GlassHouse used...
Source: Mass Device - September 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Nuvasive Source Type: news

NuVasive shares slide on negative note short seller report
UPDATE: Removed reference to financial group Cowen & Co. after verification that it did not release any negative sentiments towards NuVasive based on the GlassHouse report. NuVasive Inc. (NSDQ:NUVA) shares dropped over 7% after the release of a report from short seller GlassHouse Research which accused the company of “irregular accounting,” according to a Benzinga report. The short seller’s report claims that the company was using accounting tricks to hide that its organic business is in decline, according to Benzinga, and accuses the company of inflating its earnings and growth numbers. GlassHou...
Source: Mass Device - September 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Nuvasive Source Type: news

Report: Hurricane Maria poses threat to med device hub in Puerto Rico
[Image courtesy of NOAA]Hurricane Maria is posing a threat to medical device and pharmaceutical manufacturing plants in Puerto Rico, according to a new Bloomberg report. The island is home to facilities for Johnson & Johnson (NYSE:JNJ), Pfizer (NYSE:PFE), Amgen (NSDQ:AMGN), Merck, Medtronic (NYSE:MDT) , Abbott (NYSE:ABT), Stryker (NYSE:SYK) and dozens of others, according to the report. Most of the companies created facilities in Puerto Rico due to tax incentives, Bloomberg reports. The storm is poised to do massive damage to the island’s infrastruc...
Source: Mass Device - September 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blog Business/Financial News Source Type: news

Cook Medical parent company sells subsidiary for $950M
The parent company of Cook Medical, which operates an endoscopy division in Winston-Salem, has sold one of its subsidiary companies for $950 million. Cook Group announced Tuesday that it is selling Cook Pharmica, a privately held, biologics-focused contract development and manufacturing organization, to Somerset, N.J.-based Catalent for $750 million cash at closing and the remainder in four annual installments. The Winston-Salem facility, whic h focuses on medical device manufacturing, is wholly… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - September 20, 2017 Category: American Health Authors: Rebecca Troyer Source Type: news

UK warns about alarm failure for Roche ’s insulin pumps
The UK’s Medicines and Healthcare products Regulatory Agency issued a medical device alert for Roche‘s (OTC:RHHBY) Accu-Check Insight insulin pumps today, warning that the device’s audible and vibration alarms may not function. If a user doesn’t see the notification message on the pump and can’t hear or feel an alarm, it could lead to hyperglycemia, the agency said. Get the full story at our sister site, Drug Delivery Business News. The post UK warns about alarm failure for Roche’s insulin pumps appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - September 20, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug Pumps Drug-Device Combinations Pharmaceuticals Regulatory/Compliance Wall Street Beat Roche Roche Diabetes Care Source Type: news

Medical Device Alert: All Accu-Chek Insight insulin pumps- risk of alarm failure
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert ... (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - September 20, 2017 Category: Drugs & Pharmacology Source Type: news

Report: Boston Scientific could still seek to pull Synergy stent from India
Boston Scientific (NYSE:BSX) is reportedly still considering a market withdrawal in India for its Synergy adsorbable polymer stent, after repeated attempts to lift a government-imposed price cap were rebuffed by regulators there. Representatives from the Marlborough, Mass.-based medical device giant met yesterday with National Pharmaceutical Pricing Authority officials to discuss pulling Synergy from India, according to LiveMint. The NPPA last week said no changes to the price caps would be considered until February 2018, a year after the caps went into effect, according to the website, which cited a ” pers...
Source: Mass Device - September 20, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Stents Wall Street Beat Boston Scientific Indian National Pharmaceutical Pricing Authority (NPPA) Meril Life Science Source Type: news

If packaging on your medical device is wet or damaged, do not use product inside. #HurricaneMaria #HurricaneSeason http://go.usa.gov/xRMgN   pic.twitter.com/mYo9YBCFWE
If packaging on your medical device is wet or damaged, do not use product inside. #HurricaneMaria #HurricaneSeason http://go.usa.gov/xRMgN  pic.twitter.com/mYo9YBCFWE (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 20, 2017 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Russian regulators changing medical device, IVD regulations
By Stewart Eisenhart, Emergo Group The Russian government has indicated that it may loosen some rules for registration of medical devices and in vitro diagnostic products (IVDs) but also increase regulatory reviews of more substantial registration changes in the coming months. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. The post Russian regulators changing medical device, IVD regulations appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - September 20, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news