FDA: Page 95
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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 -
Explore the Trendline➔
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TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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 -
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 -
Jacob Bell/MedTech Dive
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
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