Medical Devices: Page 181
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FDA digital health efforts highlighted in Trump budget
The blueprint calls for Medicare coverage for breakthrough devices.
By David Lim • March 12, 2019 -
UK to probe safety of paclitaxel cardiovascular devices
The investigation will review data linking drug-coated balloon catheters and drug-eluting stents to increased death rates, including studies of those sold by Boston Scientific, Cook Medical, C.R. Bard, Medtronic and others.
By Nick Paul Taylor • March 12, 2019 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
FDA flags surgical stapler risks, plans advisory meeting
The agency alerted healthcare providers to an increasing number of medical device reports associated with use of surgical staplers, including at least 366 deaths and more than 9,000 serious injuries.
By Susan Kelly • March 11, 2019 -
Jacob Bell/MedTech Dive
AdvaMed raises concerns with FDA's proposed De Novo model
In comments on FDA's proposed De Novo classification rule, the medical device lobby said it is concerned the framework would impose some requirements that replicate the premarket approval application review.
By Susan Kelly • March 11, 2019 -
TAVR for low-risk patients in spotlight at ACC
Jefferies analysts predict results from valve makers Edwards Lifesciences and Medtronic will "usher in the low risk era for TAVR," expanding the market for the devices.
By Susan Kelly • March 11, 2019 -
CMS updates 2021 DME bidding round plans, adds new product categories
The American Association for Homecare argued addition of non-invasive ventilators to the competitive bidding program will drive companies out of business.
By David Lim • March 11, 2019 -
In bid for new users, Fitbit expands Solera partnership
Fitbit Health Solutions COO Amy McDonough told MedTech Dive many users enrolled in a diabetes prevention program through the partnership choose to later buy a more expensive Fitbit.
By David Lim • March 8, 2019 -
Bard pulls mesh implants from EU
Despite thousands of adverse event reports globally, the BD subsidiary cited the burden of generating clinical data required by new EU rules as the reason for ceasing distribution and sales.
By Nick Paul Taylor • March 8, 2019 -
Tandem suspends software use in pivotal closed loop study to fix bug
The company sought to quell nerves, but investors pushed the stock down 8% on safety concerns.
By Nick Paul Taylor • March 7, 2019 -
Medicare panel gives equivocal backing to Novocure's brain cancer device
The panelists expressed some confidence that the Optune device improves outcomes but also raised concerns related to issues like patient compliance.
By Nick Paul Taylor • March 7, 2019 -
Pharma strikes $220M deal for pain device player Myoscience
New Jersey-based Pacira is moving into the device sector to build a portfolio of pain products capable of reducing the need for opioids.
By Nick Paul Taylor • March 6, 2019 -
FDA proposes exempting some flow cytometers from 510(k) requirements
The change is intended to streamline the path to market for some devices that count or characterize cells.
By Nick Paul Taylor • March 6, 2019 -
Device to detect internal bleeding wins De Novo clearance
The monitoring system targets patients who could experience complications during percutaneous procedures using large diameter catheters such as TAVR.
By Susan Kelly • March 5, 2019 -
Masimo brain monitor gets CE mark pediatric indication
The device is now available for use in patients between ages 1 and 18 who undergo anesthesia for surgical or diagnostic procedures.
By Susan Kelly • March 5, 2019 -
US kidney care getting revamp, HHS officials say
HHS Secretary Alex Azar pushed for the development of wearable and implantable artificial kidneys.
By Rebecca Pifer Parduhn • March 4, 2019 -
Deep Dive
Mixing medicine and money: Why the rise of health system VCs is raising ethical concerns
More dollars than ever are flowing from VCs affiliated with nonprofit health systems, spurring questions around conflicts of interest.
By Taylor McKnight • March 4, 2019 -
CVS to close retail audiology centers ahead of over-the-counter regulations
FDA has made clear it believes consumers should be able to take a more active role in managing hearing loss.
By David Lim • March 4, 2019 -
Scientists propose universal standard to calibrate CT scanners
The measurement approach could improve comparison of scans from different machines, potentially making diagnosis more efficient and less costly.
By Susan Kelly • March 4, 2019 -
Medtronic says corrected IN.PACT analysis to be published in JACC
The revision, prompted by a data error, complicates an already contentious debate about long-term safety of drug-coated balloons in treating peripheral artery disease.
By Susan Kelly • March 4, 2019 -
As robotic surgery booms, FDA cautions against use for cancer
Agency leaders cited lack of evidence on safety and effectiveness, but major health systems report using the tech for cancer patients.
By Maria Rachal • March 1, 2019 -
Gene test for antibiotic resistance gets FDA breakthrough nod
The World Health Organization has identified antibiotic resistance as one of the biggest threats to global health.
By Susan Kelly • March 1, 2019 -
EU debuts drug-device Q&A ahead of regulatory changes
The guidance sets out how incoming medical device regulations will affect developers of pre-filled syringes and other combination products.
By Nick Paul Taylor • March 1, 2019 -
Moody's warns medtech is highly vulnerable to cyberattacks
The credit rating agency said impact of an attack would still not rival the severity of one on the broader healthcare industry.
By Nick Paul Taylor • March 1, 2019 -
Gottlieb pledges device, drug reviews will be on time post shutdown
The FDA chief's appearance before Congress comes a day after a bill was introduced to allow the agency to accept new medical device applications and user fees during a government shutdown.
By David Lim • Feb. 28, 2019 -
Boston Scientific Lotus matches Medtronic CoreValve in head-to-head TAVR trial
The readout comes as Boston Scientific prepares to introduce its device in the U.S. and Europe.
By Nick Paul Taylor • Feb. 28, 2019
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