Policy & Regulation: Page 2
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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
The latest letter to healthcare providers follows the agency's warning in February of a far higher mortality rate seen in post-approval study of Impella RP than was reported in initial clinical trials.
By Susan Kelly • May 22, 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 -
SponsoredExpert 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 -
Physicians call for Digital Health Scorecard to validate products
Following the models of consumer product evaluation organizations, doctors want transparent evaluations of new technologies.
By Nick Paul Taylor • May 16, 2019 -
B. Braun invests $1B in IV fluid manufacturing to alleviate shortages
FDA's task force on drug shortages is expected to submit a report to Congress by year's end outlining potential solutions to address root causes of scarcities.
By David Lim • May 15, 2019 -
Medical equipment hit by escalation of US-China trade war
Between tariffs already enacted and an additional $300 billion in products on the table, imaging equipment, diagnostic reagents, surgical gloves and contact lenses stand to be among the medical devices affected.
By Nick Paul Taylor • May 15, 2019 -
CMS will weigh broader mitral valve repair NCD, analysts predict
Cowen analysts think Medicare's Coverage Analysis Group is likely to reconsider the national coverage determination for mitral valve repair in the second half of the year, which could benefit MitraClip maker Abbott.
By Susan Kelly • May 14, 2019 -
FDA extends Abiomed heart pump use to 14 days
The new label more than doubles authorized length of use of the pumps and positions physicians to give critically ill patients longer to recover before deciding on next steps.
By Nick Paul Taylor • May 14, 2019 -
AliveCor snags FDA clearance for six-lead EKG
Alongside an April clearance for its KardiaAI software to help identify bradycardia and tachycardia, the company is positioning itself to compete with the latest Apple Watch's electrocardiogram function.
By David Lim • May 13, 2019 -
Medicare contractors propose narrow coverage for glioblastoma treatment
The local coverage determination for Novocure's device will likely be finalized by late summer or early fall and go into effect after a 45-day notice period.
By Susan Kelly • May 13, 2019 -
Sen. Murray renews scrutiny of duodenoscope makers
The top Democrat on the HELP committee is asking manufacturers Olympus, Fujifilm and Pentax how they plan to respond to FDA data showing what the senator calls "alarmingly high rates of contamination."
By David Lim • UPDATED: May 13, 2019 at 9:14 a.m. -
BD lowers guidance as FDA paclitaxel alert dents prospects
The medtech expects sales of paclitaxel-coated balloons to fall 50% in the wake of FDA recommending against use of the devices.
By Nick Paul Taylor • May 09, 2019 -
FDA grants De Novo to device for cerebral aneurysms
The temporary coil embolization assist device can deliver better outcomes than stents and balloon remodeling, Israeli manufacturer Rapid Medical says.
By Nick Paul Taylor • May 09, 2019
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