Log in to search using one of your social media accounts:

MassDevice.com +5 | The top 5 medtech stories for June 23, 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. Bard wins FDA approval for LifeStream covered iliac stent C.R. Bard said today that it won pre-market approval from the FDA for its LifeStream covered iliac stent for treating peripheral artery disease. The PMA covers the treat...
Source: Mass Device - June 23, 2017 Category: Medical Devices Authors: MassDevice Tags: Blog News Well Plus 5 Source Type: news

Here are the top 5 medtech stories of mid-2017
[Image from Unsplash]The middle of 2017 is shaping up to be a continued whirlwind of activity for medtech. FDA is getting used to its new leadership but is facing a continued lack of clarity on user fees and UDIs. Industry is seeing a deeper consolidation in medical supplies, exemplified in Cardinal Health’s purchase of patient recovery supplies from Medtronic. And patient-focused health is increasingly married to consumer electronics – the latest example being Dexcom’s recent partnerships with Apple to incorporate glucose sensors into the Apple Watch. Read on to find out more about the top stor...
Source: Mass Device - June 23, 2017 Category: Medical Devices Authors: Heather Thompson Tags: Business/Financial News Diabetes Food & Drug Administration (FDA) Mergers & Acquisitions mHealth (Mobile Health) Regulatory/Compliance Apple Apple Watch BD bectondickinson C.R. Bard Cardinal Health Dexcom Medtronic spectrumplas Source Type: news

Request 4 Nominations 4 Voting Members - Device GMP Advisory Comm & Medical Devices Advisory Comm https://go.usa.gov/xNfQP   #medicaldevice
Request 4 Nominations 4 Voting Members - Device GMP Advisory Comm & Medical Devices Advisory Comm https://go.usa.gov/xNfQP  #medicaldevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 23, 2017 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Medtronic ’ s board OKs $5B stock buyback, raises dividend 7%
The board of directors at Medtronic (NYSE:MDT) OK’d a $5 billion stock buyback program today and raised the medical device maker’s dividend payout by 7%. The new repurchasing program supersedes a 2015 plan to reacquire 80 million shares, or about 6% of the total at that time. Today Medtronic said it’s also raising its dividend to 46¢ per share, representing an annual dividend of $1.84 per share. The dividend-per-share payout ratio is 40% of last year’s adjusted earnings per share of $4.60, the company said. It’s the 40th consecutive dividend increase, which including today’s boost g...
Source: Mass Device - June 23, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Wall Street Beat Medtronic Source Type: news

Brazilian medical device regulators change registration submission formats
By Stewart Eisenhart, Emergo Group Brazilian medical device regulator ANVISA has adjusted its electronic submission policy for marketing authorization applications, now accepting both electronic and paper formats of documents. 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 Brazilian medical device regulators change registration submission formats appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 23, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

Ask Well: Do M.R.I. Scans Cause Any Harm?
Magnetic resonance imaging doesn ’ t carry the radiation risks of X-rays or PET scans. But there are safety issues to watch out for. (Source: NYT Health)
Source: NYT Health - June 23, 2017 Category: Consumer Health News Authors: KAREN WEINTRAUB Tags: Magnetic Resonance Imagers Medical Devices X-Rays Radiation Accidents and Safety Source Type: news

Affordable Care Act Reform —Patient and Public Safety Must Transcend Politics
(Source: MDDI)
Source: MDDI - June 23, 2017 Category: Medical Devices Authors: MDDI Staff Tags: Regulatory and Compliance Source Type: news

Philips buys Eugene medical device maker for $36M
The health care arm of European-based technology firm Royal Philips is buying Eugene-based medical device maker Electrical Geodesics Inc. for roughly $36.7 million. Electrical Geodesics makes non-invasive devices used to monitor brain activity and help make diagnoses. Founded in 1992, the company has 90 employees. Last year it had revenue of $14.3 million. Philips was interested in the company’s technology to compliment its own imaging portfolio and softwa re tools. EGI’s products are used in… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 22, 2017 Category: Biotechnology Authors: Malia Spencer Source Type: news

Philips buys Eugene medical device maker for $36M
The health care arm of European-based technology firm Royal Philips is buying Eugene-based medical device maker Electrical Geodesics Inc. for roughly $36.7 million. Electrical Geodesics makes non-invasive devices used to monitor brain activity and help make diagnoses. Founded in 1992, the company has 90 employees. Last year it had revenue of $14.3 million. Philips was interested in the company’s technology to compliment its own imaging portfolio and softwa re tools. EGI’s products are used in… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - June 22, 2017 Category: American Health Authors: Malia Spencer Source Type: news

How to grow your medical device business through its life cycle
While every medical device business founder daydreams of pre-revenue exits and unicorn valuations, it is imperative to plan for the long and unpredictable haul. Richard F. Mattern, Bass, Berry & Sims PLC [Image from Unsplash]Despite the starting point being nearly universal (founder sees a clinical need, a promising market opportunity and a path to regulatory approval or clearance), a business’ opportunities, challenges and capital can vary significantly. Your corporate focus and related legal needs can shift through your medical device company’s life cycle as it grows. Surviving the burn (early stage) Whil...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News bassberrysims startups Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 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. pSivida seeks European regulatory nod for Durasert pSivida is looking to market its Durasert 3-year treatment for posterior segment uveitis in the European Union. Today, the Watertown, Mass.-based company submitted a marketing ...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Blurred Lines: The Convergence of Med Device and Pharma in 2017
(Source: MDDI)
Source: MDDI - June 22, 2017 Category: Medical Devices Authors: Jamie Hartford Tags: Medical Device Business Source Type: news

Senate hews to House blueprint with new Trumpcare bill
A new U.S. Senate version of the Trumpcare bill largely hews to the structure of the healthcare reform bill that passed the House last month, reportedly handing a huge tax cut to the rich by slashing the government’s contribution to the Medicaid program for the poor. The Senate bill would create a new tax credit for health insurance purchases and would allow states to drop Obamacare benefits such as maternity care, emergency services and mental health treatment, the New York Times reported. Although the Senate version would offer more financial help for the poor than its House counterpart, like that measure it w...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Healthcare Reform Capitol Hill Source Type: news

No longer love that tattoo of your former flame'Biff'? Learn about tattoo removal: options and results https://go.usa.gov/xNw7c   pic.twitter.com/AgFmEb6mJa
No longer love that tattoo of your former flame 'Biff'? Learn about tattoo removal: options and results https://go.usa.gov/xNw7c  pic.twitter.com/AgFmEb6mJa (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 22, 2017 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

#SaferSex Tip: #condoms + birth control=DBL protection against pregnancy, HIV/#STDs < https://go.usa.gov/xNv4j   pic.twitter.com/1O3p03oL7W
#SaferSex Tip: #condoms + birth control=DBL protection against pregnancy, HIV/ #STDs< https://go.usa.gov/xNv4j  pic.twitter.com/1O3p03oL7W (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 22, 2017 Category: Medical Devices Authors: ( at CDCSTD) Source Type: news

FDA Science: Working at the speed of emerging technologies
FDA Acting Chief Scientist Luciana Borio By Luciana Borio, M.D. Let’s face it, we’ve all gotten used to nearly instant access to almost anything. Today, with a tap of an app, we order a car ride, a book, or pizza for dinner. Need to navigate past traffic in downtown city streets? No problem. There’s an app for that, too. Some may wonder: Why hasn’t rapid medical product development partaken of this need for speed that has reshaped other sectors of our economy? Well, in many ways, it has. Innovation is happening extraordinarily fast in the biomedical sciences and at FDA. As FDA’s Acting Chief S...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog FDA Voice Source Type: news

Philips to Acquire Electrical Geodesics, Inc. to Establish Integrated Neurological Imaging, Mapping and Therapy guidance Portfolio
Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced an agreement to acquire Electrical Geodesics, Inc. (EGI), a US-based medical device company that designs, develops and commercializes a range of non-invasive technologies used to monitor and interpret brain activity. (Source: eHealth News EU)
Source: eHealth News EU - June 22, 2017 Category: Information Technology Tags: Featured Philips Business and Industry Source Type: news

Using Patent Rights to Control Medical Devices Post-Sale —Not So, Says Supreme Court
(Source: MDDI)
Source: MDDI - June 22, 2017 Category: Medical Devices Authors: MDDI Staff Tags: Regulatory and Compliance Source Type: news

5 secrets of contract manufacturing longevity
Whether it’s a few decades or the better part of a century, there are important factors that enable a contract manufacturer to last for a long time – business traits that OEM customers should value. We asked top executives from long-lasting medical device industry suppliers to share their secrets.  [Image from Unsplash]Mike Ondercin started Cleveland-based Criterion as a tool-and-dye company in 1953. Today Criterion is a precision manufacturing facility owned by Ondercin’s granddaughter Tanya DiSalvo – who bought out the former owner, her dad. The company doubled its employee roster over t...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Contract Manufacturing criterion donatelle infusmedical MTD Micro Molding sil-pro Source Type: news

Impedimed wins CE Mark for Sozo monitoring system
Australian medtech developer ImpediMed said today it won CE Mark approval in the European Union for its Sozo bioimpedance spectroscopy platform. The Sozo system is designed to non-invasively measure and monitor fluid status and body composition using the company’s L-Dex lateral lymphedema assessment system. With the clearance, the Sozo platform is indicated for use as a bioimpedance spectroscopy platform for use in hospitals, clinics and in patient’s homes under a clinician’s direction, the company said. “Obtaining CE Mark for multiple indications for the Sozo platform is a pivotal regulat...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Diagnostics Regulatory/Compliance ImpediMed Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 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. CBO scores Senate’s FDA user fees bill The Congressional Budget Office last week scored a U.S. Senate bill to re-up the user fee agreement between the medical device and pharmaceutical industries, saying it would add $740...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

LivaNova wins expanded MR indication for VNS Therapy device
LivaNova (NSDQ:LIVN) said today it won FDA approval for expanded MRI labeling for its Vagus Nerve Stimulation Therapy device, touting it as the only epilepsy device cleared by the FDA for MRI scans. With the approval, patients with the minimally invasive VNS system are cleared to visit any MRI center in the US, with access to more than 90% of routine scans for patients with epilepsy, the London-based company said. “The FDA’s approval to expand our MRI labeling changes the landscape for device-based epilepsy therapies. This further differentiates our technology from other epilepsy treatment options and adds...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance Source Type: news

#Recall: Vascular Solutions Inc. Venture Catheters - Excess Material May Split or Separate During Use https://go.usa.gov/xNwKA   #fda
#Recall: Vascular Solutions Inc. Venture Catheters - Excess Material May Split or Separate During Use https://go.usa.gov/xNwKA  #fda (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 21, 2017 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Medtronic wins reprieve in ‘ free services ’ false claims suit
A federal judge in Pennsylvania this week dismissed with leave to amend False Claims Act allegations suggesting Medtronic (NYSE:MDT) offered free services and support to customers to entice them to buy its medical devices on grounds that the suit did not clearly identify how the support services crossed the line and acted as kickbacks. The claims allege that Medtronic “paid healthcare providers illegal kickbacks in the form of free services and staff to induce providers to choose the defendant’s products over those of its competitors,” according to court documents. Medtronic filed to dismiss the amen...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Legal News Medtronic Source Type: news

Digital health devices: FDA ’ s plan for innovation
Dr. Scott Gottlieb, FDA commissioner It is incumbent upon FDA to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By taking an efficient, risk-based approach to our regulation, FDA can promote health through the creation of more new and beneficial medical technologies. We can also help reduce the development costs for these innovations by making sure that our own policies and tools are modern and efficient, giving entrepreneurs more opportunities to dev...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Food & Drug Administration (FDA) mHealth (Mobile Health) News Well FDA Voice Source Type: news

J & J, Medtronic push back against TGA priority review proposal
Johnson & Johnson (NYSE:JNJ) and Medtronic (NYSE:MDT) are pushing back against the Australian Therapeutic Goods Administration’s proposed priority review pathway for medical devices, citing faults in the proposal that they claim will keep them from using it, according to a RAPS report. The major medtech players said they had doubts whether the pathway, designed to hasten approval, would actually cut time to get medical devices to patients in the region. The companies also voiced concerns that the pathway could negatively impact new and breakthrough devices, according to the report. “We have concer...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance johnsonjohnson Medtronic Source Type: news

CBO scores Senate ’ s FDA user fees bill
The Congressional Budget Office last week scored a U.S. Senate bill to re-up the user fee agreement between the medical device and pharmaceutical industries, saying it would add $740 million to the budget and a negligible amount to the deficit over 2017 to 2022. The “FDA Reauthorization Act of 2017” would see medical device companies put up a collective $1 billion in user fees, which pharma firms putting up another $8 billion for drug reviews, the budget office estimated. That money, the fees companies pay to have the federal safety watchdog review their products, would offset most of the increase in ...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Capitol Hill User fees Source Type: news

410 Medical Receives Funding from Triangle Venture Alliance (TVA) - A Newly Formed Network Based on Angel Investors tied to Leading North Carolina Universities
410 Medical Marks First Ever Investment by Triangle Venture Alliance DURHAM, N.C., June 21, 2017 -- (Healthcare Sales & Marketing Network) -- 410 Medical, Inc., a medical device company focused on developing innovative technologies for the resuscitatio... Devices, Venture Capital 410 Medical, LifeFlow (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 21, 2017 Category: Pharmaceuticals Source Type: news

EnteroMedics Announces vBloc Therapy to be Presented by Keynote Speaker at Major International Obesity Conference
ST. PAUL, Minn., June 21, 2017 -- (Healthcare Sales & Marketing Network) -- EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that Scott Shikora, M... Devices EnteroMedics, vBloc , Neurometabolic Therapy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 21, 2017 Category: Pharmaceuticals Source Type: news

Fostering medical innovation: A plan for digital health devices
By: Scott Gottlieb, M.D. It is incumbent upon FDA to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By taking an efficient, risk-based approach to our regulation, FDA can promote health through the creation of more new and beneficial medical technologies. We can also help reduce the development costs for these innovations by making sure that our own policies and tools are modern and efficient, giving entrepreneurs more opportunities to develop product...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog FDA Voice Source Type: news

The Power Struggle behind Wearable Medical Device Design
(Source: MDDI)
Source: MDDI - June 21, 2017 Category: Medical Devices Authors: MDDI Staff Tags: Research and Development Source Type: news

UC consortium formed to speed up development of new drugs
For 12 years, UCLA researcher Dennis Slamon pursued a groundbreaking approach to treating breast cancer: Attack the disease genetically.The journey was long and filled with obstacles, but his persistence paid off.Slamon and colleagues conducted laboratory and clinical research that, in collaboration with biotechnology firm Genentech, helped lead to development of the breast cancer drug Herceptin.UCLA's Dennis Slamon with Harry Connick Jr., who played the professor of medicine in a 2008 television movie.The drug, which targets a specific genetic alteration found in about 25 percent of breast cancer patients, has saved thous...
Source: UCLA Newsroom: Health Sciences - June 21, 2017 Category: Universities & Medical Training Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 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. Using CRM devices as forensic clues Pacemakers and other cardiac rhythm management devices could help solve forensic cases by revealing a time and cause of death in cases where an autopsy is inadequate, according to a study pre...
Source: Mass Device - June 20, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Acelity taps Jokinen as CFO, exec VP | Personnel Moves June 20, 2017
Acelity said last week it tapped Tracy Jokinen as its chief financial officer and executive vice president, taking over for interim CFO Todd Wyatt. Jokinen was formerly a CFO of uniform and facility services provider G&K services, which was acquired by Cintas earlier this year. Prior to working at G&K, Jokinen spent more than 20 years at Valspar Corp, holding a number of different leadership roles. The company said that interim CFO Wyatt will transition into a new leadership role as part of the senior management team. “Tracy has a dynamic combination of skill and experience that is uniquely suited t...
Source: Mass Device - June 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Acelity Attune Medical Avedro Inc. CSA Medical Inc. Delphinus Medical Technologies Inc. Entellus Medical Inc. fireflymedical Mazor Robotics Medtronic personnel-moves SetPoint Medical Unilife Corp. Source Type: news

How to achieve better medical device outcomes through behavior change
Will Randall, ZS Associates [Image courtesy of jar [o] on Flickr, per Creative Commons 2.0 license]I often pause in restaurant bathrooms, amused by the familiar signage above the sink: “Employees must wash hands before returning to work.” Surely everyone washes their hands. While these well-meaning but rather amusing signs are found all over the U.S., do they actually have any impact on improving hygiene practices? Probably not. But what does that have to do with medtech, anyway? Imagine that a hospital introduces a surgeon to a new device by simply hanging a sign over the operating table with one line of instr...
Source: Mass Device - June 20, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Product Liability Recalls ZS Associates Source Type: news

Slips Technologies raises $9m for coatings tech
Slips Technologies said today that it raised nearly $9 million for the super-slippery coating it’s developing, including a $3 million grant from a U.S. Energy Dept. agency. Named for its technology, “slippery liquid-infused porous surfaces,” the Cambridge, Mass.-based company’s coating is designed to create a self-healing liquid layer that’s too slippery for other fluids to adhere to. Slips, a spinout of Harvard’s Wyss Institute, said the coating can be applied to materials including plastic, metal, ceramic, glass and concrete. The tech is based on the slippery surface of ...
Source: Mass Device - June 20, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Wall Street Beat Coatings slipstechnologies Source Type: news

Medtronic touts cost, treatment data on CRT devices
Medtronic (NYSE:MDT) today touted data showing that a pair of algorithms improved treatment and lowered costs for patients treated with its cardiac resynchronization therapy devices. The Fridley, Minn.-based medical device giant said its AdaptivCRT and EffectiveCRT algorithms lowered costs and improved therapy delivery in heart failure patients with atrial fibrillation. Results from 1 of 3 analyses presented at the European Heart Rhythm Assn. Europace Cardiostim conference in Vienna this week showed that the AdaptivCRT program cut the lifetime cost of treatment by an average of €1,055 (about $1,174) in 3 Eur...
Source: Mass Device - June 20, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Cardiac Rhythm Management Medtronic Source Type: news

Medical device execs find ally in HHS chief Price on medtech tax
The covey of medical device executives that alit on Capitol Hill last week to lobby for repealing the medtech tax and getting a new user fee deal with the FDA in place reportedly found a ready ally in Dr. Tom Price, head of the U.S. Health & Human Services Dept. More than 50 medical device company officials met with dozens of legislators and federal officials June 15, pressing for a repeal of the 2.3% tax on U.S. medtech sales enacted as part of Obamacare. Although the tax is currently in abeyance, it’s set to go back into effect next year. Price told the execs, who were on The Hill under the auspices of AdvaMed,...
Source: Mass Device - June 20, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Regulatory/Compliance Capitol Hill Medical Device Tax User fees Source Type: news

Peruvian regulators push for faster medical device approval timeframes
By Stewart Eisenhart, Emergo Group The Peruvian government has rolled out a raft of updates to the country’s medical device regulatory system, including an initiative to reduce approval timeframes for all device classes. 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 Peruvian regulators push for faster medical device approval timeframes appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 20, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

Botswana: Chinese Doctor, Entrepreneur Donate Medical Equipment to Botswana Hospital
[Focac] Gaborone -Chinese medical equipment worth 100,000 U.S. dollars were donated Friday to Nyangabgwe Hospital in Francistown, some 430 km northeast of Botswana's capital Gaborone. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - June 20, 2017 Category: African Health Source Type: news

Elekta Aims for More Accurate Radiation Therapy with Unity
(Source: MDDI)
Source: MDDI - June 20, 2017 Category: Medical Devices Authors: MDDI Staff Tags: Medical Device Business Source Type: news

Fujifilm wins DoD nod for Synapse PACS line
Fujifilm Holdings (TSE:4901) subsidiary Fujifilm Medical Systems said today it won an Authority to Operate from the US Department of Defense for its Synapse PACS line, touting it as the 1st such product to receive a risk management framework based ATO. With the clearance, the US DoD has determined that the Synaps PACS line meets its RMF controls, including the DoD 8500 Series controls and the Security and Techinical Implementation Guide requirements. The clearance is valid until March 2020. “This latest ATO from the Department of Defense is testimony to the fact that risk mitigation remains a top priority at Fuj...
Source: Mass Device - June 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Fujifilm Holdings Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 19, 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. Medtronic touts retrospective data in Reactive ATP therapy AF study Medtronic‘s today released data from a retrospective analysis of patients with its Reactive ATP therapy, touting slowed atrial fibrillation progression f...
Source: Mass Device - June 19, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

U.S. legislators ask India to reconsider stent price caps
(Reuters) – A group of U.S. lawmakers has backed medical device makers by urging India to reconsider its decision to cap prices of heart stents, raising the issue ahead of Prime Minister Narendra Modi’s visit to the United States later this week. In a letter sent to the Indian ambassador to Washington last month, and seen by Reuters, 18 members of Congress said they were “troubled” by the price cap, warning that it could deter firms from launching new medical products in India. Modi’s government has in recent years capped prices of hundreds of life-saving drugs to make them more affordable. An...
Source: Mass Device - June 19, 2017 Category: Medical Devices Authors: MassDevice Tags: Business/Financial News Stent Grafts Stents Source Type: news

Inspired by War Zones, Balloon Device May Save Civilians From Fatal Blood Loss
Developed to save victims of battlefield trauma, a plastic tube with a balloon at its tip can give doctors precious time to halt internal bleeding. (Source: NYT Health)
Source: NYT Health - June 19, 2017 Category: Consumer Health News Authors: DENISE GRADY Tags: Medical Devices Surgery and Surgeons Pelvis Bellevue Hospital Center ER-Reboa catheter Source Type: news

An Interview with Medtronic's Luann Pendy
(Source: MDDI)
Source: MDDI - June 19, 2017 Category: Medical Devices Authors: MDDI Staff Tags: Medical Device Business Source Type: news

MicroPort < sup > ® < /sup > Attends OCC 2017
(Source: Microport News Release)
Source: Microport News Release - June 19, 2017 Category: Medical Devices Source Type: news

FDA expands 510(k) validation data requirements for reusable devices
By Stewart Eisenhart, Emergo Group Medical device market regulators at the Food and Drug Administration have issued a new list of reusable medical devices for which validated Instructions for Use as well as validation data for cleaning and sterilization will be required for 510(k) submissions. 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 expands 510(k) validation data requirements for reusable devices appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 19, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

Exclusive: Ahead of Modi visit, U.S. lawmakers ask India to rethink price cap on stents
NEW DELHI (Reuters) - A group of U.S. lawmakers has backed medical device makers by urging India to reconsider its decision to cap prices of heart stents, raising the issue ahead of Prime Minister Narendra Modi's visit to the United States later this week. (Source: Reuters: Health)
Source: Reuters: Health - June 19, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Blended: Pharma's New Multi-Stakeholder Model
Physicians, patients, payers, providers, policy makers, partners, regulators, shareholders; the once slowing moving stream of pharma stakeholders has swollen into a roaring cataract in recent years.The currents carrying pharma towards an ever-greater focus on patients, collaborations and technology are gaining power too, putting even more strain on existing assumptions and models.However, among all the many stakeholders, the focus on the patient is paramount, says Bharat Tewarie, EVP and Chief Marketing Officer at UCB. “This means that we have to organize ourselves internally around the value that we create for our p...
Source: EyeForPharma - June 19, 2017 Category: Pharmaceuticals Authors: Nick de Cent Source Type: news