FDA: Page 94
-
FDA rolls out plan to reduce third party 510(k) re-reviews
Commissioner Scott Gottlieb said outsourcing review of low-risk devices can enable FDA to focus more resources on high-risk and more complex devices.
By David Lim • Sept. 14, 2018 -
FDA softens voluntary consensus guidance after industry slams 'devastating' draft
Feedback to the agency contended the consensus standard proposals would hurt small companies. An update doesn't completely reverse course.
By Nick Paul Taylor • Sept. 14, 2018 -
Explore the Trendlineâž”
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 -
FDA delays Inbrija drug-device combo
Regulators need more time to assess the biotech's Parkinson's drug-device combination, adding another layer of complexity to manufacturing and approval processes.
By Jacob Bell • Sept. 13, 2018 -
House passes bill to amend local Medicare coverage decisions
The medical device industry contends the local decisions can be arbitrary and opaque.
By Nick Paul Taylor • Sept. 13, 2018 -
FDA moves to single electronic filings for device submissions
The change would end the need for companies to file on paper and submit multiple copies.
By Nick Paul Taylor • Sept. 13, 2018 -
Medtronic plants hit with FDA warning letters
The notices relate to two facilities that made recalled implantable cardioverter-defibrillators.
By Nick Paul Taylor • Sept. 12, 2018 -
Cook resolves FDA warning letter that slammed quality processes
The close-out letter follows four years of work to improve quality management.
By Nick Paul Taylor • Sept. 12, 2018 -
A call to make EHRs safer for pediatric patients
A viewpoint published in JAMA Pediatrics argues for a rigorous certification program for electronic health records used in pediatric care to prevent harm to young patients.
By Susan Kelly • Sept. 11, 2018 -
AliveCor snags FDA breakthrough device status for bloodless hyperkalemia test
The agency has granted the designation, which fast tracks review, to 83 devices as of the end of July.
By David Lim • Sept. 11, 2018 -
Bundled payment model cuts joint replacement costs in study
The evaluation of the Comprehensive Care for Joint Replacement program, prepared for CMS, found the drop in costs was primarily due to reduced use of post-acute care institutions.
By Susan Kelly • Sept. 10, 2018 -
Watchdog slams Veterans Health Administration on device sterility
GAO investigators found failings in the oversight of reusable medical equipment cleaning.
By Nick Paul Taylor • Sept. 6, 2018 -
Gottlieb: UnitedHealth, CareFirst sign onto FDA pilot aiming to speed device coverage
The FDA chief also outlined new programs including "QUiK Review" aimed at cutting review times for low-risk 510(k) submissions "by as much as 30%."
By David Lim • Sept. 5, 2018 -
FDA adds 1.6M hours to estimate of device labeling burden
The agency thinks changes to recordkeeping and disclosures have added to regulatory weight.
By Nick Paul Taylor • Sept. 5, 2018 -
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 -
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
Previous
