FDA: Page 86
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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 -
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 -
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 finalize narrow coverage for glioblastoma treatment
The local coverage determination for Novocure's tumor treatment field therapy will go into effect Sept. 1.
By Susan Kelly • Updated July 19, 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 -
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 9, 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 9, 2019 -
CMS pushes back 2021 DME bidding program window to July
The Competitive Bidding Implementation Contractor released a 55-page guide and 18 additional fact sheets with instructions for the 2021 bidding round.
By David Lim • May 8, 2019 -
FDA finalizes laser guidelines, rebuffing calls for harmonization
The agency acknowledged the advantages of harmonization but will continue to enforce its own standards for now.
By Nick Paul Taylor • May 8, 2019 -
ACLA, AdvaMedDx, BIO call for VALID Act movement by year-end
Despite differences between clinical labs and diagnostic manufacturers, industry wants to keep the legislation at the top of mind for Congress before the election and user fee negotiations suck oxygen away from the effort next year.
By David Lim • May 7, 2019 -
Jacob Bell/MedTech Dive
FDA issues final guide on device submission meetings, feedback
The agency also announced it will hold a webinar on June 11 to discuss the Q-Submission program.
By Susan Kelly • May 7, 2019 -
Kendall Davis/MedTech Dive
Touchstone Medical Imaging pays $3M to settle HIPAA breach case
HHS found Touchstone failed to properly investigate the security incident until months after it learned of the breach.
By Nick Paul Taylor • May 7, 2019 -
EU issues device, diagnostics database requirements
The documents detail what data manufacturers will need to include in the European Database on Medical Devices for devices and in vitro diagnostics under its new regulations.
By Susan Kelly • May 6, 2019 -
Boston Scientific wins FDA approval for Vici stent
The go-ahead creates competition for BD's Venovo stent, approved in March. Cook Medical and Medtronic are currently working to get their own versions to market.
By David Lim • May 6, 2019 -
FDA seeks info on how patients view risks and benefits of devices
One health policy analyst was skeptical of the initiative, pointing to what she characterized as industry recruitment of desperate patients willing to use insufficiently tested products.
By Dana Elfin • May 3, 2019 -
FDA plan to limit old predicates not happening soon, 510(k) regulator says
A decision to cut off use of old predicates at a specific age would "be awful," Marjorie Shulman, the assistant director of 510(k)s at FDA, said.
By David Lim • May 3, 2019 -
FDA ends summary reporting, says it will not ban any breast implants
The agency laid out plans to improve the accessibility of safety information about breast implants and also announced it will make public all prior adverse event reports related to the devices within a matter of weeks.
By Maria Rachal • May 3, 2019 -
CMS to revamp coding for new medical technology
Medical device companies will now be able to apply for a new permanent Healthcare Common Procedure Coding System code twice a year instead of annually.
By David Lim • May 3, 2019 -
Medtronic gets FDA approval for wireless pacemaker programmer
The device is the follow-up to CareLink 2090, which has been dogged by cybersecurity weaknesses.
By Nick Paul Taylor • May 3, 2019
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