FDA: Page 84
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Germany, Ireland push EU to assess device regs preparedness
The delegations think a significant reduction in notified bodies is likely but hope to avoid delaying implementation "unless absolutely necessary."
By Nick Paul Taylor • June 12, 2019 -
EU names UDI issuers in move to new medtech regs
Four organizations will support implementation of UDI systems under the new EU Medical Device Regulation and In Vitro Diagnostics Regulation.
By Susan Kelly • June 11, 2019 -
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 -
Quest, LabCorp breach stirs questions of cybersecurity risk from outside vendors
The breach could result in new regulations and rules governing how U.S. companies select and assess their vendors, according to Moody's.
By Rebecca Pifer Parduhn • Updated June 11, 2019 -
Edwin Lopez/MedTech Dive
Medtech avoids tariff blow as US, Mexico reach deal
President Donald Trump late Friday called off plans for a 5% tariff set to go into effect today on imports from Mexico.
By Susan Kelly • June 10, 2019 -
Kendall Davis/MedTech Dive
Deep DiveInside Quest Diagnostics, LabCorp's supply chain breach
The intrusion happened inside the American Medical Collection Agency, but responsibility is shared through its partner ecosystem.
By Samantha Schwartz • June 6, 2019 -
FDA approves DT MedTech's total ankle replacement implant
The company will aim to compete with Stryker and Zimmer Biomet.
By Nick Paul Taylor • June 6, 2019 -
House committee passes 6% increase in FDA funding
The committee wants one FDA priority, the Transform Medical Device Safety, Cybersecurity, Review, and Innovation initiative, to make do with the same level of funding as it received in fiscal 2019.
By Nick Paul Taylor • June 5, 2019 -
Device industry praises FDA AI/ML framework, asks for Class III software inclusion
AdvaMed and the Combination Products Coalition applauded the agency's work on a regulatory approach for the emerging technology, but gave a slew of recommendations for FDA to consider as it develops a potential draft guidance.
By David Lim • June 4, 2019 -
EMA posts draft guidance on drug-device combinations
The European Medicines Agency published the text to inform companies of their obligations under the regulations set to come into force across the continent next year.
By Nick Paul Taylor • June 4, 2019 -
FDA consults surgical device experts on down-classing certain hemostatic agents
Johnson & Johnson's Ethicon opposes loosening premarket requirements for the devices, maintaining strict controls are needed to ensure patient safety.
By Maria Rachal • May 31, 2019 -
DME industry ramps up lobbying efforts ahead of 2020 proposed rule
Key health lawmakers in the House and Senate are lending support to AAHomecare in its bid to prevent CMS from adding non-invasive ventilators to its competitive bidding program in 2021.
By David Lim • May 31, 2019 -
GS1 updates UDI guideline to reflect changes to FDA position
Among the almost 20 new subsections added by GS1 are several intended to help device companies get started with UDIs.
By Nick Paul Taylor • May 31, 2019 -
Medtech groups call for immediate action to avoid EU regulatory cliff
The trade groups think the system is "very unlikely" to be ready in time, raising fears of severe supply disruption.
By Nick Paul Taylor • May 30, 2019 -
Medtronic gets FDA greenlight to expand His-bundle pacing portfolio
The catheter system is designed to address the challenges of His bundle anatomy by giving physicians more maneuverability and an adjustable form.
By Nick Paul Taylor • May 30, 2019 -
Health Canada makes it official: Macrotextured breast implants off the market
Regulators concluded Allergan's Biocell surface implants boost the risk of developing cancer, outweighing potential benefits. The decision conflicts with FDA's stance citing insufficient evidence to support a U.S. ban.
By Maria Rachal • May 29, 2019 -
FDA experts meet to mull up-classing surgical staplers
Thursday's advisory panel meeting comes amid identification of adverse tissue reactions, infections and complications associated with device malfunction and user error — and 412 reports of death.
By Maria Rachal • May 29, 2019 -
IMDRF posts guidance on custom-made device exemptions
The text covers the eligibility of products for custom-made device pathways and the rules governing such technologies.
By Nick Paul Taylor • May 29, 2019 -
FDA approves Novocure device to treat rare lung cancer
The marketing authorization on the strength of a single-arm study drew criticism, with one prominent physician calling it a "new low" for FDA.
By Nick Paul Taylor • May 28, 2019 -
Industry slams FDA idea to limit old 510(k) predicates
Between 2015 and 2018, approximately 20% of 510(k) applications were cleared based on a predicate older than 10 years, according to FDA.
By David Lim • May 24, 2019 -
FDA authorizes Zika test, mulls revoking emergency clearances
The agency granted the first non-emergency marketing authorization for a Zika virus diagnostic to InBios.
By Nick Paul Taylor • May 24, 2019 -
Faulty platelet counts trigger Class I recall of Beckman Coulter devices
FDA is aware of more than 2,000 U.S. laboratories that may be affected by the inaccurate platelet counting but, so far, the agency hasn't received any reports of serious adverse events.
By Nick Paul Taylor • May 24, 2019 -
Quality failings spur FDA crackdown on 2 defibrillator businesses
Inspectors identified the same problems in 2018 as two years prior, leading the agency to send warning letters.
By Nick Paul Taylor • May 24, 2019 -
Anti-Kickback Statute safe harbor revisions set for July
The newly released Spring 2019 Unified Agenda lays out government plans to align domestic and international medical device quality systems, define which types of software are considered devices, and more.
By David Lim • May 23, 2019 -
FDA wants new companies to help test its Pre-Cert Program
One pilot company's CEO told MedTech Dive FDA's search for new companies "is not a surprise to us" and "is a really good thing for the Pre-Cert program."
By David Lim • May 23, 2019 -
FDA on Abiomed right heart device: patient selection is key
In its latest update on the safety of Impella RP, FDA said Monday the most recent post-approval study results for the device show comparable survival outcomes among patients who would have qualified for premarket studies.
By Susan Kelly • Updated Dec. 3, 2019
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