FDA: Page 84
-
Fresenius gets breakthrough status for hemodialysis software
The experimental software makes recommendations to improve fluid management and thereby cut the rate of complications.
By Nick Paul Taylor • March 15, 2019 -
FDA ramps up major CDRH reorg, aiming for 'super office'
The restructuring will integrate pre and postmarket offices and shift to teams based on product type rather than life cycle. It kicks off Monday.
By Nick Paul Taylor • March 14, 2019 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
HemoSonics gets De Novo nod for POC coagulation device
The test uses ultrasound to quickly analyze blood samples at the point of care.
By Nick Paul Taylor • March 14, 2019 -
Navigating FDA's evolving device pathways: A primer
The agency is touting the biggest alterations to medtech approval processes in the decades since it began reviewing devices. Here's a roundup of the current regulatory framework and what's potentially changing.
By Meg Bryant • March 13, 2019 -
FDA qualifies test for traumatic brain injury
The OsiriX CDE test can now be used by medical device developers to identify and enroll patients in studies of TBI, which has been researched for years but has no effective treatment.
By Susan Kelly • March 13, 2019 -
NCI Director Ned Sharpless to be named FDA acting commissioner
Sharpless will succeed FDA Commissioner Scott Gottlieb in early April. He has served as director of the National Cancer Institute since October 2017.
By David Lim , Maria Rachal • Updated March 12, 2019 -
NCI Director Ned Sharpless to be FDA acting commissioner
Sharpless will succeed FDA Commissioner Scott Gottlieb in early April. He has served as director of the National Cancer Institute since October 2017.
By Maria Rachal • March 12, 2019 -
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 -
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 -
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 -
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 -
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
Previous
