FDA: Page 90
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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 -
Latest FDA Pre-Cert working model garners tepid support
AdvaMed argued the program's promise may be compromised without legislation giving the agency more authority.
By David Lim • March 12, 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 -
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 -
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 -
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 -
FDA advisers weigh in on HPV screens
The non-voting advisory committee's recommendations aimed to broaden clinical study participation and predicate evaluation of new tests on relative performance against a clinical endpoint comparator.
By Maria Rachal • Updated March 19, 2019 -
Low upfront costs fuel investor interest in health app startups, analysts say
A new report highlights low development costs as a factor that may encourage new entrants to stick with the sector despite changing regulations and concerns about data security.
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 -
What does Gottlieb's resignation mean for medtech?
CDRH chief Jeff Shuren was a steady force as four different FDA commissioners cycled through the agency's top spot in 2019.
By David Lim , Maria Rachal • 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 -
Paying patients to shop MRIs results in some savings: Health Affairs
Price reductions were mostly seen in imaging services. During the first 12 months of the program, MRI prices fell by 4.7%, ultrasound by 2.5%, mammograms by 1.7% and CT scans by 1.4%.
By Meg Bryant • March 5, 2019 -
FDA Commissioner Scott Gottlieb to step down in a month
The exit comes as the agency revamps its medical device approval pathways.
By David Lim • Updated March 5, 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 -
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 -
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 -
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 -
Hologic gets EU clearance for breast lesion localization tag
The device uses radio frequency identification to wirelessly guide surgeons to breast lesions.
By Nick Paul Taylor • Feb. 28, 2019 -
UK updates Brexit medtech advice as cliff edge exit looms
The Medicines and Healthcare products Regulatory Agency document sheds new light on the responsible person requirement and parallel importing policy.
By Nick Paul Taylor • Feb. 28, 2019 -
Feds team up to speed diagnostic testing access in emergencies
Labs using an in vitro diagnostic granted an Emergency Use Authorization must still comply with Clinical Laboratory Improvement Amendments regulations.
By David Lim • Feb. 27, 2019 -
Biotronik's drug-eluting stent expands to US market with PMA
The Orsiro system for coronary artery disease will play against Abbott's Xience and Medtronic's Resolute.
By Maria Rachal • Feb. 25, 2019 -
Prosthetics controlled by brain implants in the offing, FDA says
Such devices may sound like science fiction, but in conjunction with a draft guidance on the topic, Commissioner Scott Gottlieb called the possibility within reach.
By David Lim • Feb. 25, 2019 -
Deep Dive
Neuromodulation market expands amid hunt for opioid alternatives
Stigma, cost and risk of surgery don't seem to be stopping growth of devices that target nerve activity central to diseases like Alzheimer's, epilepsy and chronic pain.
By Meg Bryant • Feb. 22, 2019 -
FDA rule on device study practices comes into force
The final rule mandates the use of good clinical practices by sponsors of trials based outside the U.S.
By Nick Paul Taylor • Feb. 22, 2019
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