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Medical Design and Manufacturing Challenges to Be Explored at ADM Cleveland
The challenges of medical manufacturing, from evolving quality systems requirements to determining whether to outsource a technology or keep it in house, will be explored at free conference sessions during the upcoming Advanced Design & Manufacturing (ADM) Expo in Cleveland, OH. The trade show and conference comes to the Huntington Convention Center of Cleveland on March 7 and 8. A panel discussion on March 7 will dive into ISO 13485 certification, including the latest version of the international standard for medical device quality management systems. ISO 13485:2016 introduces a number of revisions that medical device...
Source: MDDI - February 21, 2018 Category: Medical Devices Tags: Plastics Today Source Type: news

Under Pressure: MiMedx Faces an Uncertain Future
An internal investigation has thrown MiMedx into a state of uncertainty. The Marietta, GA-based company said Tuesday it is postponing the release of its financial results and the filing of its Form 10-K for 2017, while independent legal and accounting advisors investigate allegations regarding the company's sales and distribution practices at the company. MiMedx said its executives are also reviewing the accounting treatment of certain distributor contracts.  The company's stock (Nasdaq: MDXG) fell 39.53% Tuesday, closing at $8.75, and at least one analyst decided to downgrade the stock citing "too much uncertain...
Source: MDDI - February 20, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Source Type: news

Whistleblower Complaint Against Obalon Found to be Unjustified
Late last month Obalon pulled the plug on a $35 million stock offering to investigate allegations of improper revenue recognition during the company's fourth quarter. Obalon said that investigation is now complete and the allegations in the complaint are without merit. "We took the whistleblower complaint very seriously and conducted a thorough investigation," said Les Howe, chair of Obalon's audit committee. "The investigators found no merit to any of the whistleblower allegations, determined that preliminary revenues were not misrepresented and that management did nothing to mislead investors." P...
Source: MDDI - February 20, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Source Type: news

Medtronic is Making the Most of Value-Based Care
Medical device companies of all sizes have embraced value-based healthcare in recent years, and one of the industry's top companies is now beginning to see its value-based care programs pay off. "I know I have spoken a lot about value-based healthcare, but I'm particularly pleased to see this translate into real numbers, which have real differentiating value for Medtronic," CEO Omar Ishrak said during Medtronic's third-quarter earnings call Tuesday, according to Seeking Alpha transcripts. Learn more about the future of innovation in the value-based care system at the BIOMEDevice Boston conference, April 18-1...
Source: MDDI - February 20, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Source Type: news

New Vaginal Mesh Implant Material Could Reduce Complications, Accelerate Healing
Vaginal mesh implants made of polypropylene have caused severe medical complications in millions of women across the world, and medical manufacturers from Johnson & Johnson to Bard, acquired by BD last year, have been mired in lawsuits as a result. Now, scientists at the University of Sheffield in the United Kingdom have developed an alternative polyurethane material to treat pelvic organ prolapse and incontinence that is better suited for use in the pelvic floor. Moreover, they have embedded the material with estrogen, which is released into the surrounding pelvic tissue to form new blood vessels and accelerate the he...
Source: MDDI - February 20, 2018 Category: Medical Devices Tags: Plastics Today Source Type: news

FDA removed 10% of medtech establishments from its registration database: Here ’s why
David Lennarz, Registrar Corp. The U.S. FDA has removed 2,546 medical device establishments from its active registration database.  As of Feb. 19, the FDA database contained 24,578 registered establishments, compared to 27,124 registered establishments on Feb. 2. So why did FDA remove the registrations? Get the full story on our sister site Medical Design & Outsourcing.  The post FDA removed 10% of medtech establishments from its registration database: Here’s why appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 20, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: Food & Drug Administration (FDA) News Well Registrar Corp. Source Type: news

UPDATE: Robotics delay pushes Medtronic down despite fiscal Q3 beats
Medtronic (NYSE:MDT) shares took a hit today after the world’s largest medical device maker said its robot-assisted surgery platform has fallen behind schedule, despite fiscal third-quarter results that topped the consensus forecast on Wall Street. Fridley, Minn.-based Medtronic had predicted first-in-human cases during the fiscal year ending in April, with a full launch following in fiscal 2019. But during a conference call with investors today discussing the Q3 numbers, chairman & CEO Omar Ishrak said the timetable has gotten longer. “We are enthusiastic about the development of our surgical robotics plat...
Source: Mass Device - February 20, 2018 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat Medtronic Source Type: news

J & amp;J Acquisition Could Give Stryker a Run for Its Money in Robotics
Johnson & Johnson is taking a deeper dive into the surgical robotics market through its latest acquisition. The New Brunswick, NJ-based company, through its French affiliate Apsis, will pick up Orthotaxy, a privately held developer of software-enabled surgical technologies, including a differentiated robotic-assisted surgery solution, for an undisclosed sum. J&J said the technology is currently in early-stage development for total and partial knee replacement, and the company plans to broaden its application for a range of orthopedic surgery procedures. Network with your colleagues in medtech at ADM ...
Source: MDDI - February 20, 2018 Category: Medical Devices Authors: Omar Ford Tags: Medical Device Business Source Type: news

Pacemakers, other devices at risk for hacking, study says
Medical devices like pacemakers and insulin pumps are at risk for hacking the could have deadly consequences, warns a new report by the American College of Cardiology. (Source: the Mail online | Health)
Source: the Mail online | Health - February 20, 2018 Category: Consumer Health News Source Type: news

Cincinnati medical device maker gets board refresh
Medical device maker AtriCure Inc. revealed today that Scott Drake will become chairman of the board of the publicly traded company in May. Drake, previously CEO of medical device maker Spectranetics Corp., has been a director of Mason-based AtriCure since September 2013. The company (Nasdaq: ATRC) is best known for making medical devices to treat atrial fibrillation, a common malady characterized by an irregular and fast heartbeat. Richard Johnston, a director of Atricure since 2002 and chairman… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - February 20, 2018 Category: Biotechnology Authors: Barrett J. Brunsman Source Type: news

Johnson & Johnson picks up French robot-assisted surgery firm Orthotaxy
Johnson & Johnson (NYSE:JNJ) said today that its medical device business paid an undisclosed amount to acquire French robot-assisted surgery company Orthotaxy. J&J said it plans to expand the early-stage technology from total and partial knee replacements into other orthopedic surgeries as part of its bid to create a new robot-assisted platform using “enabling technologies to personalize procedures, optimize surgery and bring value to customers and patients.” “Our goal is to bring to market a robotic-assisted surgery technology that is an integral part of a comprehensive orthopedics platform, deli...
Source: Mass Device - February 20, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Robotics Wall Street Beat johnsonandjohnson orthotaxy Source Type: news

Johnson & Johnson Medical Devices Companies Acquire Orthotaxy to Develop Next-Generation Robotic-Assisted Surgery Platform in Orthopaedics
(Source: Johnson and Johnson)
Source: Johnson and Johnson - February 20, 2018 Category: Pharmaceuticals Source Type: news

Johnson and Johnson Medical Devices Companies Acquire Orthotaxy to Develop Next-Generation Robotic-Assisted Surgery Platform in Orthopaedics
PARIS, Feb. 20, 2018 -- (Healthcare Sales & Marketing Network) -- Johnson & Johnson Medical Devices Companies, through French affiliate Apsis S.A.S., announced today the acquisition of Orthotaxy, a privately-held developer of software-enabled surgery tech... Devices, Mergers & Acquisitions Johnson & Johnson, DePuy Synthes, Orthotaxy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 20, 2018 Category: Pharmaceuticals Source Type: news

Medtronic ’ s Q3 beats expectations
Medtronic (NYSE:MDT) posted fiscal third-quarter results today that topped the consensus forecast on Wall Street, despite taking a $2.2 billion hit from last year’s tax reforms. The Fridley, Minn.-based medical device titan posted losses of -$1.39 billion, or -$1.03 per share, on sales of $7.37 billion for the three months ended Jan. 26, compared with profits of $821 million on sales growth of 1.2% compared with fiscal Q3 2017. Adjusted to exclude one-time items, earnings per share were $1.18, a penny ahead of The Street, where analysts were looking for sales of $7.20 billion. “Our results reflect a solid quart...
Source: Mass Device - February 20, 2018 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat Medtronic Source Type: news

Blockchain Based Medical Device from NnBU Set to Raise €15million in ICO
New Neonatal Birth Unit is a World First to Improve Health Outcomes of Babies Born by C-Section NICOSIA, Cyprus, February 19, 2018 -- (Healthcare Sales & Marketing Network) --Today, Monday February 19 2018, NnBU Holdings Ltd (https://nnbu.io) announces... Devices, Venture Capital NnBU Holdings, blockchain, neonatal birth unit (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 19, 2018 Category: Pharmaceuticals Source Type: news

Are we poisoning our children with plastic?
The chemical BPA is widely added to food and drink packaging, and more than 80% of teenagers have it in their bodies. But how dangerous is it?Can exposure to plastics harm your health? It ’s a question currently being explored by researchers after a recent study suggested that traces of a synthetic chemical called Bisphenol A (BPA) can be found inmore than 80% of teenagers. BPA is added to plastic to create a special form called polycarbonate plastic, used in making robust, impact-resistant materials for everything from food and drink packaging to DVD cases and medical devices. First created in 1891, it has been used...
Source: Guardian Unlimited Science - February 19, 2018 Category: Science Authors: David Cox Tags: Health & wellbeing Life and style Society Plastics Environment Chemistry Science Cancer Cancer research Medical research Source Type: news

FDA Oks First Blood Based Concussion Detection Test
A new blood-based test could help change the way TBI’s such as concussions are detected in patients. FDA recently granted a De Novo request to Banyan Biomarkers to market the Banyan Brain Trauma Indicator (BTI). “The goal standard right now is the CT scan and it’s better than anything else out there,” Henry Nordhoff, chairman and CEO of Banyan Biomarkers, told MD+DI. “But the problem with CT is the cost; the time it takes; and the amount of ionizing radiation that’s delivered to the brain. It’s particularly dangerous when it’s a developing brain. You’re getting about 10...
Source: MDDI - February 19, 2018 Category: Medical Devices Authors: Omar Ford Tags: Medical Device Business Source Type: news

FDA OKs First Blood-Based Concussion Detection Test
A new blood-based test could help change the way TBI’s such as concussions are detected in patients. FDA recently granted a De Novo request to Banyan Biomarkers to market the Banyan Brain Trauma Indicator (BTI). “The goal standard right now is the CT scan and it’s better than anything else out there,” Henry Nordhoff, chairman and CEO of Banyan Biomarkers, told MD+DI. “But the problem with CT is the cost; the time it takes; and the amount of ionizing radiation that’s delivered to the brain. It’s particularly dangerous when it’s a developing brain. You’re getting about 10...
Source: MDDI - February 16, 2018 Category: Medical Devices Authors: Omar Ford Tags: Medical Device Business Source Type: news

DOD-Backed MeMed Feels the Need for Speed
An Israeli startup that has developed a platform to differentiate between viral and bacterial infections in 15 minutes just got a big boost toward bringing the product to market. The U.S. Department of Defense (DoD) has given Haifa-based MeMed a $4 million grant to fund its manufacturing efforts. MeMed’s technology measures three blood-borne immune markers to detect whether a patient has a bacterial or viral infection. Its first generation product, ImmunoXpert, has been cleared for use in laboratories in the EU, Switzerland, and Israel. The platform under development, ImmunoPoC, is designed for point-of-care use to h...
Source: MDDI - February 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: IVD Source Type: news

BD Accuses Cytek of Stealing Trade Secrets
Becton Dickinson (BD) is the latest medtech company to take a competitor to court for alleged trade secret theft. The company recently filed a lawsuit against Cytek Biosciences and nine former BD employees, claiming that when these employees left BD to work for Cytek they retained and misused BD's "valuable, highly confidential, proprietary information," including thousands of technical files they had downloaded from BD's computer systems onto removable storage media while still employed with the company. "Cytek recently hired away nearly a dozen scientists, engineers, and business people...
Source: MDDI - February 16, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Source Type: news

Valeritas Presents Data Demonstrating V-Go & #194; & #174; Wearable Insulin Delivery Device ...
BRIDGEWATER, N.J., Feb. 15, 2018 - Valeritas Holdings, Inc. (NASDAQ:VLRX), a medical technology company which offers patients with type 2 diabetes V-Go® Wearable Insulin Delivery device, a simple, affordable, all-in-one insulin delivery option that is worn like a patch and can eliminate the need for taking multiple daily shots, announced today it presented positive findings from its MOTIV4CONTROL study as a poster at The 11th International Conference on Advanced Technologies&...This story is related to the following:Medical Devices (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - February 16, 2018 Category: Medical Devices Source Type: news

These trends have made medical device manufacturing what it is today
About 10 years ago, there were a number of notable trends and market forces which began to, once again, change how the medical device manufacturing sector brought its products to market. They’re still shaping the market we have today. Andrew Potter, Bonifacio Consulting Services, and Chris Delporte [Image from Unsplash]Perhaps the true measure of a forward-thinking industry is its ability to evolve to meet new market challenges, demands and opportunities. The medical device industry — and certainly the contract manufacturing sector that has grown over the last two decades into an integral part of medtech’...
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Heather Thompson Tags: Business/Financial News Contract Manufacturing Outsourcing Bonifacio Consulting Services Source Type: news

Attivo Networks receives validation from BD for BOTsink cybersecurity solution
[Image courtesy of Blogtrepreneur on Flickr, per Creative Commons 2.0 license]Attivo Networks recently announced that it has received validation through a BD Product Security Partner Program for its BOTsink cybersecurity deception solution when used with BD devices. The company recently expanded its IOT portfolio and the BD collaboration will allow for improved detection capabilities against cyber threats that impact medical devices. The deception-based threat detection in the BOTsink features decoys and lures that misdirect potential attackers from production assets. Through the collaboration, BOTsink decoys will provide ...
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Health Information Technology Attivo Networks BD Cybersecurity MedTech Source Type: news

Recent Study Looks at How Consumers Use Wearables That Generate Biometric data and Whether Such Data Might Be Valuable for Physicians and Medical Laboratories
Precision medicine programs can benefit from wearable usage data; however, little information has been collected on personalities and behaviors of the device users Wearables medical devices have the potential to monitor some of the same biomarkers used in medical laboratory tests today. In addition, these mobile technologies can make it possible for clinical laboratories to […] (Source: Dark Daily)
Source: Dark Daily - February 16, 2018 Category: Laboratory Medicine Authors: Jude Tags: Instruments & Equipment Laboratory Instruments & Laboratory Equipment Laboratory Management and Operations Laboratory News Laboratory Pathology Management & Operations Activity Tracker anatomic pathologist Annals of Internal Medicine cli Source Type: news

Tandem inks distribution deal in Scandinavia for insulin pumps
Tandem Diabetes Care (NSDQ:TNDM) has inked a distribution agreement with Rubin Medical to commercialize the medical device company’s t:slim X2 insulin pump, insulin cartridges and t:lock infusion sets in Sweden, Norway and Denmark. According to the terms of the deal, Rubin Medical is slated to perform all sales, marketing and customer training for Tandem’s devices. Get the full story at our sister site, Drug Delivery Business News. The post Tandem inks distribution deal in Scandinavia for insulin pumps appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Pharmaceuticals Wall Street Beat tandemdiabetes Source Type: news

Gambia:Sharab Medical Center Receives Grant
[Foroyaa] Mr. Daisuke Enomoto, Second Secretary of the Japanese Embassy in The Gambia, on Tuesday 13th February 2018, presided over a signing ceremony dedicated for a grant for the execution of a project to supplying medical equipment to Sharab Medical Center . (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - February 16, 2018 Category: African Health Source Type: news

Edwards Adds Bold New Chapter to TAVR Story
Edwards Lifesciences just might have leaped-frogged over some of its competitors in the burgeoning  TAVR market. The undisputed TAVR pioneer has received CE mark for its Centera valve to treat severe, symptomatic aortic stenosis patients at high risk of open-heart surgery. The Edwards Centera valve is repositionable and retrievable and can be delivered through a low-profile, 14-French, motorized delivery system. The company said the device is packaged with the valve fully pre-attached to the delivery system, which helps with simple and rapid device preparation. Network with your colleagues in medtech at ADM&...
Source: MDDI - February 15, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Medical Device Business Source Type: news

New biopolymer liquid bandage has received FDA approval
(Natural News) A liquid skin bandage has been approved for licensing and sale by the U.S. Food and Drug Administration (FDA). Known as ElaSkin, the biopolymer liquid bandage is the first commercial product by the biomaterials and medical device start-up, Aleo BME. ElaSkin possesses a variety of characteristics that help make it a “best-in class technology,”... (Source: NaturalNews.com)
Source: NaturalNews.com - February 15, 2018 Category: Consumer Health News Source Type: news

Recently Approved Device- Consumer Information on: Aptima HBV Quant assay - P170025 https://go.usa.gov/xnF3d   #MedicalDevice
Recently Approved Device- Consumer Information on: Aptima HBV Quant assay - P170025 https://go.usa.gov/xnF3d  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 15, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

MSQA Insights- Direct-to-Patient Mammogram Results: It ’ s the Law- https://go.usa.gov/xnF3E   #MedicalDevice
MSQA Insights- Direct-to-Patient Mammogram Results: It’s the Law- https://go.usa.gov/xnF3E  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 15, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Supplier Stories for the Week of February 11
(Source: MDDI)
Source: MDDI - February 15, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Components Source Type: news

FDA authorizes marketing of 1st blood test to aid in eval of concussion in adults. Most patients eval'd for concussion w/ a CT scan don't have detectable brain tissue damage. This quick testing option helps reduce the need for CT scans, radiation exposure https://go.usa.gov/xnFxq   pic.twitter.com/srv921peN7
FDA authorizes marketing of 1st blood test to aid in eval of concussion in adults. Most patients eval'd for concussion w/ a CT scan don't have detectable brain tissue damage. This quick testing option helps reduce the need for CT scans, radiation exposure https://go.usa.gov/xnFxq  pic.twitter.com/srv921peN7 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 15, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Perflow Medical Closes $12 Million in Financing to Treat Complex Neurovascular Disorders
Announces successful completion of over 50 commercial cases with the Stream™ Dynamic Neuro-Thrombectomy Net TEL AVIV, Israel, Feb. 15, 2018 -- (Healthcare Sales & Marketing Network) -- Perflow Medical, an Israeli-based medical device company that devel... Devices, Interventional, Neurology, Venture Capital Perflow Medical, CEREBRAL NET, Thrombectomy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 15, 2018 Category: Pharmaceuticals Source Type: news

Pittsburgh medical device firm bought for $250M
A medical technology company based in London announced an agreement to buy a Pittsburgh firm focused on advanced cardiopulmonary temporary support solutions for $250 million. LivaNova PLC said it is acquiring CardiacAssist Inc., which does business as TandemLife and is based in O’Hara Township. The deal is expected to close by the end of June. LivaNova said upfront costs of the transaction total $200 million, with up to $50 million in contingent considerations based on regulatory milestones. TandemLife’s… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - February 15, 2018 Category: Health Management Authors: Patty Tascarella Source Type: news

Edwards Lifesciences wins CE Mark for Centera TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its self-expanding transcatheter Centera aortic heart valve, with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Irvine, Calif.-based company said. “With the Edwards Centera valve, European clinicians and their patients may now benefit from a self-ex...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news

Pittsburgh medical device firm bought for $250M
A medical technology company based in London announced an agreement to buy a Pittsburgh firm focused on advanced cardiopulmonary temporary support solutions for $250 million. LivaNova PLC said it is acquiring CardiacAssist Inc., which does business as TandemLife and is based in O’Hara Township. The deal is expected to close by the end of June. LivaNova said upfront costs of the transaction total $200 million, with up to $50 million in contingent considerations based on regulatory milestones. TandemLife’s… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - February 15, 2018 Category: Biotechnology Authors: Patty Tascarella Source Type: news

Government to come out with new pharma policy: Ananth Kumar
The big healthcare initiative announced in the budget for 2018-19 seeks to cover 10 crore households requires many verticals -- infrastructure, human resources and pharma and medical device products. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - February 15, 2018 Category: Pharmaceuticals Source Type: news

Top Medtech Companies of 2017: Notable Newcomers
(Source: MDDI)
Source: MDDI - February 15, 2018 Category: Medical Devices Authors: Jamie Hartford Tags: Medical Device Business Source Type: news

LivaNova Pumps Up its Heart Portfolio with TandemLife Deal
London-based LivaNova has been cutting deals left and right lately in an effort to focus on its areas of strength, such as cardiac surgery and neuromodulation. That's the reason the company gave last year for shedding its cardiac rhythm management business, and then for acquiring ImThera Medical.  Now the company has its sights on Pittsburgh, PA-based TandemLife. Don't miss the Advanced Design and Manufacturing Conference and Expo, March 7-8, 2018, in Cleveland, OH. LivaNova has agreed to pay $200 million upfront and up to $50 million more once certain regulatory milestones have been met.  TandemLife's advan...
Source: MDDI - February 15, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Cardiovascular Source Type: news

Medical Adhesive Secures a Golden Mousetrap Award
As wearable medical devices continue to emerge, a growing older population coupled with an increasing incidence of chronic diseases requiring active monitoring is driving the need for durable yet comfortable adhesives, reports John Dugas, global business manager, 3M’s Critical and Chronic Care Solutions Division. “Whether it’s affixed for several hours, a day, or even a week, the device needs to stay attached to do its job,” he said. 3M’s 4076 Extended Wear Medical Tape, launched last August, was recently recognized with a Golden Mousetrap Award in the Materials & Assembly: Adhesives ...
Source: MDDI - February 15, 2018 Category: Medical Devices Authors: Daphne Allen Tags: MD & M West (Anaheim) Adhesives Source Type: news

Biocoat, Inc. Names Jim Moran President and CEO
Moran brings extensive medical device and startup expertise to growing biomaterial coatings company(PRWeb February 15, 2018)Read the full story at http://www.prweb.com/releases/2018/02/prweb15214440.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - February 15, 2018 Category: Pharmaceuticals Source Type: news

Mazor CEO: Robotics is Here to Stay
During Mazor Robotics' fourth-quarter earnings call, executives mentioned Medtronic almost as much as they mentioned their own company. And for good reason.  The company received 24 purchase orders for its Mazor X robotic system in the fourth quarter of 2017, and all but one of those orders came from Medtronic. Under a global distribution sale that occurred ahead of schedule last year, Medtronic has assumed exclusive global responsibility for Mazor X's commercial activity for spine surgery. Learn how to design a surgical robotic system from an expert in the field at BIOMEDevice Boston on April 18, 2018. Mazor CFO...
Source: MDDI - February 14, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Orthopedics Medical Device Business Source Type: news

Is FDA Getting More Cozy with AI?
The use of artificial intelligence (AI) is undoubtedly on the rise in healthcare. From fledging medtech companies to established giants like Watson IBM—many firms are riding the current AI wave. Not only are companies embracing technology, but so is FDA. Recently the agency gave approval to San Francisco-based Viz.ai’s Contact application, a type of clinical decision support software designed to analyze CT results that could notify providers of a potential stroke in their patients. “What it’s doing is comparing the imaging features in that patient with the millions of images it has been tr...
Source: MDDI - February 14, 2018 Category: Medical Devices Authors: Omar Ford Tags: Medical Device Business Digital Health Source Type: news

FDA authorizes marketing of 1st blood test to aid in eval of concussion in adults. Most patients eval'd for concussion w/ a CT scan don't have detectable brain tissue damage. This quick testing option helps reduce the need for CT scans, radiation exposure https://go.usa.gov/xn6vh   pic.twitter.com/QQzznfsvmI
FDA authorizes marketing of 1st blood test to aid in eval of concussion in adults. Most patients eval'd for concussion w/ a CT scan don't have detectable brain tissue damage. This quick testing option helps reduce the need for CT scans, radiation exposure https://go.usa.gov/xn6vh  pic.twitter.com/QQzznfsvmI (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2018 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Cardiovascular Systems launches Diamondback 360 EL in the US, touts 1st patients treated
Cardiovascular Systems (NSDQ:CSII) said today it launched its FDA-cleared extended length Diamondback 360 peripheral orbital atherectomy device in the US and that the first commercial patients have been treated with the device. The first procedures were performed at the Detroit Medical Center Heart Hospital by Dr. Mahir Elder and at the Arkansas Heart Hospital by Dr. Ian Cawich and Dr. Vasili Lendel, the St. Paul, Minn.-based company said. “From a physician’s perspective, radial access is a viable alternative that allows us to minimize bleeding and avoid commonly diseased femoral arteries. Additionall...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Vascular Cardiovascular Systems Inc. Source Type: news

Titan Medical touts hitting all milestones in 2017 financial results
Titan Medical (TSX:TMD) Titan Medical late yesterday released its full year 2017 financial results, touting that it met all its milestones during the year and that its Sport system was used in the first single-port procedures. The Toronto-based company reported research and development expenses of $12.9 million for the year, down from $22.6 million the company spent the previous year, with reported losses of approximately $33.6 million for the year, up from $23.3 million it reported in 2016. “I joined Titan Medical in January 2017 and based on our achievements this past year, I am more confident than ever in our...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics Surgical titanmedical Source Type: news

MD & M West: 10 technologies you should know
MD&M West is one of the largest medical device manufacturing events in the world, so it’s easy to get lost on the show floor. Even if you were in Anaheim, Calif., for the event last week, you may have missed a lot. From a new robotics insights display from Rethink Robotics to a disinfectant-resistant plastic from Eastman to Guill’s extrusion tool with single-point concentricity adjustment, here are 10 things you may have missed at MD&M West. Next>> Senior editor Heather Thompson contributed with the final two slideshow items. The post MD&M West: 10 technologies you should know appeared first o...
Source: Mass Device - February 13, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: Contract Manufacturing eastman flexcon guilltool junkosha kiniticsautomation MasterControl Maxon Motor MD&M West microcare rethinkrobotics teconnectivity Source Type: news

Ain & #039;t That a Pill: Device Could Replace Needles
Rani Therapeutics has a daunting task ahead of it. The privately held company wants to change the way some pharmaceuticals are delivered to patients. Some drugs are delivered through needles  — a method that isn’t ideal for many patients.  Rani is in the process of developing an ingestible drug-delivery pill. The San Jose, CA-based company’s RaniPill is an oral capsule that protects a drug therapy until it is ready to be delivered across the intestinal wall into the bloodstream. The RaniPill has small needles to inject the drugs into the intestinal wall once ingested. The needles will disso...
Source: MDDI - February 13, 2018 Category: Medical Devices Authors: Omar Ford Tags: Medical Device Business Implants Source Type: news

Report: Amazon gearing up for entry into medical supplies biz
Amazon (NSDQ:AMZN) is looking to up the ante in its medical supplies business and turn the unit into a major supplier to US hospitals and clinics, according to a Wall Street Journal report. The online mega retailer has initiated a trial of a new system testing to see if it can use its Amazon Business site to supply healthcare products to a large midwestern hospital and its approximately 150 outpatient facilities, according to the report. The system is customized to the hospital’s catalog of supplies and allows employees to compare prices on the Amazon Business marketplace to those it negotiates with through dist...
Source: Mass Device - February 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Distribution Hospital Care Amazon Source Type: news

India Cuts Stent Prices by More Than 7 Percent India Cuts Stent Prices by More Than 7 Percent
India has cut prices of some stents by about 7.6%, a government body said on Monday, in the latest setback for the country's $5 billion medical device industry.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - February 13, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news