FDA: Page 98
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FDA reopens comments on decade-old stent guidance
It comes days after physicians writing in The Lancet used data from a head-to-head comparison of Medtronic's Resolute Onyx and Biotronik's ultra-thin-strut stent Orsiro to highlight the limitations of noninferiority clinical trial designs.
By Nick Paul Taylor • Sept. 27, 2018 -
Jacob Bell/MedTech Dive
FDA reclassifies female condoms to reduce regulatory burden
The products will be categorized as Class II devices eligible for the 510(k) pathway.
By Nick Paul Taylor • Sept. 27, 2018 -
Explore the Trendline➔
Courtesy of Intuitive Surgical
TrendlineTop 5 stories from MedTech Dive
From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
FDA expands use of Baxter bone graft to spinal fusion
Rivals Medtronic, Johnson & Johnson, Stryker and Zimmer are all competing for the bone graft substitute piece of the advanced surgery market.
By Nick Paul Taylor • Sept. 27, 2018 -
FDA
FDA's Patel touts promise of software precertification program
Despite concern from the Clinical Decision Support Coalition that FDA may not have the legal ability to launch the pilot, the agency says it will work through its current authorities.
By David Lim • Sept. 26, 2018 -
Premier gets FDA clearance for saliva-based opioid tests
The regulatory nod expands use of OralTox to oxycodone and methadone.
By Nick Paul Taylor • Sept. 26, 2018 -
Industry lobbying CMS for speedy Medicare coverage of breakthrough devices
The Center for Medicare and Medicaid Innovation may launch a demonstration project to examine how to balance speeding devices to Medicare patients with the cost implications.
By David Lim • Sept. 25, 2018 -
Medtech companies race to adapt amid vertical integration, new tech threats
The industry is increasingly sharing the risk with payers as a way to prove product value.
By Kim Dixon • Sept. 25, 2018 -
AdvaMed chief: Success in warding off tariffs, but impact rising
While medical devices aren't explicitly on the most recent list of tariffs, the list likely includes component parts used by members of the industry.
By Kim Dixon • Sept. 25, 2018 -
FDA gives final guidance on device benefits, risks in 510(k) submissions
The recommendations will help in determining substantial equivalence for devices with different characteristics that don't raise new questions of safety and effectiveness, the FDA said.
By Susan Kelly • Sept. 25, 2018 -
FDA approves Cook PAD stent as competition heats up
The approval comes shortly after Boston Scientific received clearance to sell a rival device.
By Nick Paul Taylor • Sept. 25, 2018 -
EY warns stagnant R&D, data use threatens medtech growth
Medtech R&D investment of $15.9 billion remained "relatively unchanged" in 2017 — roughly $1 billion less than the $16.4 billion companies gave back to investors through share buybacks and dividends.
By David Lim • Sept. 24, 2018 -
ACLA lab payment lawsuit dismissed by judge
The clinical lab lobby had argued HHS did not collect data from a wide enough range of laboratories when establishing Medicare payment rates.
By David Lim • Sept. 24, 2018 -
OIG advisory opinion cracks door open for device bundle warranties
The guidance comes as HHS awaits feedback on ways to improve the Anti Kickback Statute to ease obstacles to coordinated or value-based care.
By David Lim • Sept. 21, 2018 -
FDA says Florence unlikely to cause critical device shortages
The agency is closely monitoring 10 sites that make critically important devices and biological products.
By Nick Paul Taylor • Sept. 20, 2018 -
Heparin device guidance to cut overdose risk finalized
The text addresses the labeling and safety testing of heparin-containing devices and combination products.
By Nick Paul Taylor • Sept. 20, 2018 -
MYnd gets breakthrough tag for mental health decision support tool
The technology works by comparing the brain activity of a patient to those of people with similar patterns to zero in on the drugs that have worked in analogous situations in the past.
By Nick Paul Taylor • Sept. 19, 2018 -
HHS launching database of patient safety culture at ambulatory surgical centers
The decision comes as the centers are treating more patients — a trend being pushed by payers moving care away from more expensive inpatient settings.
By Les Masterson • Sept. 18, 2018 -
ACLA, AdvaMedDx urge CMS to delay payment cuts
The clinical lab trade group sued HHS last year over data collection from labs used to set Medicare reimbursement rates.
By David Lim • Sept. 18, 2018 -
Device lobby backs FDA combo product GMP plan
AdvaMed is pushing to add a section on the annual stability expectations for drug-device products and clarify rules on sampling before finalizing the text.
By Nick Paul Taylor • Sept. 18, 2018 -
FDA tests new way to shorten 510(k) review times
The agency hopes a pilot program will make submissions more efficient, cutting time to a final decision to as little as 60 days.
By Susan Kelly • Sept. 17, 2018 -
Gottlieb: FDA pursuing faster approval path for diagnostics
The agency chief said it should focus its premarket reviews on a subset of higher risk or highly novel tests, companion diagnostics and tests for home use.
By Susan Kelly • Sept. 14, 2018 -
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 -
Jacob Bell/MedTech Dive
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 -
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
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