Medical Devices: Page 152
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Sens. Warren, Murray probe FDA's 'alarming' progressive device approval idea
The Democrats gave the agency until July 8 to respond to their questions on a recent budget proposal that seeks to grant FDA a two-step approval process for medical devices for life-threatening conditions.
By David Lim • July 8, 2019 -
Edwards issues safety notice for Centera valve after reports of injury, death
The company said difficulty manipulating the device around the aortic arch has resulted in reports of vascular injury, and recommended use of a stiffer guide wire or an alternate treatment for certain types of anatomies.
By Susan Kelly • July 8, 2019 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Insulin pen smart cap maker in talks to supply Sanofi
French medical device maker Biocorp's Internet-connected cap is designed to work with a conventional insulin pen and can automatically transmit dosage data to a smartphone app.
By Susan Kelly • July 8, 2019 -
Spanish agency steps up to become an MDR notified body
The decision comes as some in the sector have expressed concerns about whether there will be enough notified bodies to adequately support the transition to the EU's new medical device rules.
By Susan Kelly • July 8, 2019 -
Invacare lays off 75 as turnaround effort drags on
The medical equipment manufacturer is making cuts in Europe and North America, adding to the steady flow in both regions in recent years.
By Nick Paul Taylor • July 4, 2019 -
Doctors significantly over-allocated times to perform joint replacements, study shows
Time periods estimated to perform medical procedures, known as relative value units, are crucial for determining how much surgeons and other doctors are paid for their work under the Medicare Physician Fee Schedule.
By Ron Shinkman • July 3, 2019 -
Wright Medical shares tumble amid report of Cartiva slowdown
Surgeons are implanting fewer of the devices to treat arthritis of the big toe as more patients report dissatisfaction with post-operative pain, degree of motion or device slippage, RBC Capital Markets analysts said in a research note.
By Susan Kelly • July 3, 2019 -
FDA patient advisory meeting set to tackle cybersecurity in devices
The September meeting will partly focus on how healthcare providers should best communicate cybersecurity risks to medical device users.
By Susan Kelly • July 3, 2019 -
CMS extends ambulatory blood pressure monitoring coverage
In a change, patients with masked hypertension will be eligible for testing.
By Nick Paul Taylor • July 3, 2019 -
International Trade Commission probes Intuitive imports following J&J complaint
The ITC began the investigation after J&J's Ethicon argued certain Intuitive stapler cartridges infringe its patents.
By Nick Paul Taylor • July 3, 2019 -
Varian, Boston Scientific seal the deal on beads business transfer
Varian Medical Systems said Wednesday it completed the $90 million purchase of Boston Scientific's drug-loadable microspheres and bland embolic beads, a transaction key to Boston Scientific's buyout of BTG finalized Monday.
By Maria Rachal • Updated Aug. 21, 2019 -
FDA finalizes rule on requesting review of CDRH decisions
The agency declined an AdvaMed request for additional time to seek supervisory review after a company receives details of a significant decision.
By David Lim • July 2, 2019 -
Ruptured Edwards balloons linked to 3 patient deaths
FDA revealed there have been 22 complaints related to rupture or puncture of an intra-aortic occlusion device, which can put patients at risk of complications like embolism, neurological damage and stroke.
By Nick Paul Taylor • July 2, 2019 -
Military-focused abdominal trauma foam earns FDA breakthrough status
The agency awarded the designation to Critical Innovations, a company developing technologies for individuals injured in combat.
By Susan Kelly • July 1, 2019 -
Boston Scientific says Watchman more cost effective than drugs for AFib
In the Journal of the American Heart Association, researchers examined long-term data pooled from the Protect AF and Prevail clinical trials of the company's Watchman device for stroke prevention in atrial fibrillation patients.
By Susan Kelly • July 1, 2019 -
Trump: US won't impose tariffs on $300B Chinese goods 'for the time being'
Existing 25% tariffs on $250 billion of Chinese goods, along with China's retaliatory tariffs, will remain in place.
By Shefali Kapadia • June 29, 2019 -
Interagency workshop to focus on device interoperability
The Health Information Technology Research and Development Interagency Working Group is seeking feedback from industry, academia and government experts on potential solutions for creating interoperable systems.
By Susan Kelly • June 28, 2019 -
Hologic promotes replacement to head diagnostics unit
Kevin Thornal, who is currently the president of the company's medical aesthetics division, will become the president of its diagnostics unit.
By Nick Paul Taylor • Updated July 22, 2019 -
Medtronic insulin pump recall lands in FDA's top risk category after cybersecurity warning
The Class I determination follows an FDA warning in June that a hacker could dangerously tamper with insulin dosing. As of Tuesday, the agency is unaware of any cases of patient harm stemming from the vulnerability.
By Nick Paul Taylor • Updated Nov. 5, 2019 -
Boston Scientific touts potential of BTG buy, structural heart strategy
The medtech giant said it plans to launch roughly 75 products and achieve up to 9% organic revenue growth by 2022, not including contributions to its interventional oncology business from the yet-to-be-finalized BTG acquisition.
By Maria Rachal • June 27, 2019 -
Health Canada to mandate medical device adverse event reporting
The new regulations will force hospitals to report incidents within 30 days.
By David Lim • June 27, 2019 -
Anthem adds Teleflex's UroLift to prostate disease coverage
The benign prostatic hyperplasia update will provide 32 million people insured by Anthem access to the implant.
By Nick Paul Taylor • June 27, 2019 -
Jacob Bell/MedTech Dive
FDA finalizes guidance on diagnostic ultrasound systems
The text hews closely to the draft the agency issued in 2017, the core of which detailed its policy on 510(k) filings.
By Nick Paul Taylor • June 27, 2019 -
US medtech market forecast to top $200B by 2023
The prediction from Fitch Solutions is based on trends like an aging population with a rising incidence of chronic disease and certain regulatory changes.
By Nick Paul Taylor • June 26, 2019 -
Smartphone heart data mirrors gold standard EKG in study
UCSF researchers said it was the largest analysis of real-world heart rate data remotely obtained and stratified by demographics and medical conditions.
By Nick Paul Taylor • June 26, 2019
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