FDA: Page
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UK sketches medtech future under no Brexit deal
With six weeks before a key deadline, the government seeks to ease the transition between old and new regulatory regimes but is unlikely to fully mitigate the impact.
By Nick Paul Taylor • Sept. 4, 2018 -
Deep Dive
FDA rarely uses its power to recall dangerous medical devices. Why not?
"Once products are on the market, it's almost an insurmountable threshold to get the agency to take action to pull them from the market," Public Citizen's Michael Carome said.
By Meg Bryant • Aug. 31, 2018 -
Explore the Trendline➔
Sarah Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Pressure builds on HHS to issue interoperability rule
"Expansion of API coverage should be carefully profiled and tested by the vendor community before becoming a regulatory requirement," says Cerner's John Travis.
By Meg Bryant • Aug. 31, 2018 -
Alcon withdraws glaucoma device amid long-term safety concerns
Five-year data linked the stent to increased endothelial cell loss.
By Nick Paul Taylor • Aug. 30, 2018 -
Gottlieb hails early breakthrough device successes, plans AI benchmarks
The commissioner set out how the FDA is accelerating the development of medical devices.
By Nick Paul Taylor • Aug. 30, 2018 -
Report offers framework for assessing EHR usability, safety
The voluntary roadmap includes criteria examples for developers and providers to use in testing EHR products at each lifecycle stage.
By Meg Bryant • Aug. 29, 2018 -
FDA warns Zimmer Biomet about quality violations at Indiana plant
The former Zimmer Holdings has struggled to integrate Biomet since acquiring its cross-town rival for $13 billion in 2015.
By Susan Kelly • Aug. 28, 2018 -
Patients getting needed supplies under DME bidding: GAO
The GAO found that the number of durable equipment suppliers decreased 8% in 2016, consistent with the years before the rate adjustments went into effect.
By Susan Kelly • Aug. 27, 2018 -
HHS asks for advice on anti-kickback rules as industry files Stark Law input
While device makers, physicians, labs and hospitals all agree changes should be made to the Stark Law to boost value-based care, the industry is split on what revisions should be made.
By David Lim • Aug. 27, 2018 -
Alex Wong via Getty Images
HHS calls for feedback on criteria for EHR reporting program
The comments will inform assessments of the interoperability and security of electronic health systems.
By Nick Paul Taylor • Aug. 24, 2018 -
Dthera gets FDA breakthrough device status for Alzheimer's digital therapeutic
The device delivers reminiscence therapy to counter anxiety and depression.
By Nick Paul Taylor • Aug. 24, 2018 -
FDA posts guidance on endpoints in osteoarthritis trials
The draft guide says more research is needed before the agency accepts structural endpoints.
By Nick Paul Taylor • Aug. 23, 2018 -
Gynesonics gets FDA nod for fibroid ablation device
The minimally-invasive device uses radiofrequency to reduce the volume of uterine fibroids.
By Nick Paul Taylor • Aug. 23, 2018 -
Mobile phones, smartphone apps could help boost patient matching, RAND report finds
There's "no magic bullet" for incentivizing patients to improve record matching, according to lead author Robert Rudin.
By Meg Bryant • Aug. 22, 2018 -
FDA approves Keytruda companion test for bladder cancer
Measuring levels of PD-L1 expressed in patients' tumors can help doctors determine who is likely to benefit from immunotherapy treatment.
By Susan Kelly • Aug. 22, 2018 -
Australia starts accepting FDA reports in device filings
The change allows companies to use U.S. documents to seek authorizations in Australia.
By Nick Paul Taylor • Aug. 22, 2018 -
FDA extends EpiPen expiration date to ease shortages
Current supply issues stemming from ongoing manufacturing delays could put children at risk as the school year approaches.
By Suzanne Elvidge • Aug. 22, 2018 -
Jacob Bell/MedTech Dive
Noninvasive magnetic stimulation for OCD wins FDA nod
The agency's clearance for OCD is an extension of a 2008 approval of transcranial magnetic stimulation to treat major depression.
By Susan Kelly • Aug. 20, 2018 -
FDA finds higher death, stroke rates for latest SynCardia artificial heart driver
The agency said it will work with SynCardia to ensure product labeling addresses the post-approval findings.
By Susan Kelly • Aug. 20, 2018 -
Doctors often fail to list conflicts in device studies: JAMA report
Doctors got the highest payouts from Medtronic, which accounted for more than $187.4 million, followed by Stryker and Intuitive Surgical, according to a JAMA analysis.
By Susan Kelly • Aug. 20, 2018 -
US agencies pitch efforts to spur gene therapy development
The chiefs of the FDA and NIH laid out proposals in a New England Journal of Medicine editorial aimed at pushing forward advances in the fast-expanding field.
By Suzanne Elvidge • Aug. 17, 2018 -
FDA details export certificate appeal process in draft guidance
The document sets out why the agency may deny requests and how manufacturers can respond.
By Nick Paul Taylor • Aug. 17, 2018 -
FDA OKs quarterly reporting of device malfunction summaries
The change is intended to reduce regulatory burdens by lowering reporting requirements.
By Nick Paul Taylor • Aug. 17, 2018 -
Teva granted FDA approval for first EpiPen generic
It's the latest blow to Mylan, which came under fire for hiking EpiPen's price over the last decade and is now facing manufacturing challenges for the flagship product.
By David Lim • Aug. 16, 2018 -
Medtronic starts selling drug-coated balloon in Japan
Studies have linked the device to lasting improvements in patients with peripheral artery disease.
By Nick Paul Taylor • Aug. 16, 2018
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