FDA: Page 85
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EMA posts draft guidance on drug-device combinations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 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
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 -
Integra LifeSciences recall draws Class I label from FDA
The New Jersey-based device maker began recalling 42,100 cerebrospinal fluid drainage systems after receiving complaints about broken stopcocks.
By Nick Paul Taylor • May 22, 2019 -
Sponsored by ZS
Expert Insights: Medtech leaders discuss vertical integration and hospital centricity
The American healthcare paradigm is currently in a state of flux, driven by social, political and economic factors that require every participant in the system to reconsider their place in the value chain.
By Brian Chapman • May 21, 2019 -
Real-world operations: NESTcc director on building a business and the future of device evaluation
The National Evaluation System for health Technology and its real-world evidence projects are finally getting off the ground. Now the center needs to secure industry's buy-in, said Rachael Fleurence, executive director.
By Maria Rachal • May 20, 2019 -
FDA warns diabetes patients against use of unauthorized devices
The agency said it received a report of a patient using a "do it yourself" management system who experienced an insulin overdose.
By Susan Kelly • May 20, 2019 -
Smiths Medical lobbies White House for better device-based opioid alternative reimbursement
The medical device industry is taking an all hands on deck approach to convince CMS for better payment in the Hospital Outpatient Prospective Payment System proposed rule.
By David Lim • May 17, 2019 -
Canada raises medical device regulatory fees
The final fee schedule reflects a compromise after industry pushed back against higher rates initially proposed.
By Susan Kelly • May 17, 2019 -
FDA classes J&J stapler recall as high risk ahead of advisory panel
More than 92,000 of the devices made by the pharma's Ethicon unit are implicated in the U.S. recall.
By Nick Paul Taylor • May 17, 2019 -
FDA calls Essure postmarket study progress 'adequate' in adverse event update
The agency said it received roughly 6,000 medical device reports related to the permanent birth control implant last year. Bayer halted U.S. sales at the end of 2018, but doctors can implant the device through the end of 2019.
By Maria Rachal • May 16, 2019
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