FDA: Page 28
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Biotronik to pay $12.95M to settle kickback allegations of 'lavish' meals, abuse of training programs
Federal prosecutors accused Biotronik of abusing a new employee program by paying physicians to provide “excessive” training and of funding lavish meals.
By Nick Paul Taylor • July 26, 2022 -
Drew Angerer via Getty Images
Philips and U.S. Justice Dept. in consent decree talks on sleep apnea, ventilator recall
The company made the announcement Monday during a second-quarter earnings call but provided few details.
By Ricky Zipp , Elise Reuter • Updated July 25, 2022 -
Explore the Trendline➔
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TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
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FDA to expand use of remote regulatory assessments beyond the pandemic
The agency plans to keep using remote assessments, saying they’ve been a “valuable tool” during the pandemic.
By Elise Reuter • July 25, 2022 -
Permission granted by iRhythm Technologies
iRhythm, Alphabet unit Verily get FDA clearances for Zio Watch and software system
Bolstered by an AI algorithm, the companies’ partnership is a step closer to catching up with the Apple Watch.
By Ricky Zipp • July 25, 2022 -
Dan Zukowski/MedTech Dive
Test makers urge House, Senate to include diagnostic reforms in user-fee bill
AdvaMedDx, Abbott and Roche are among companies asking lawmakers to address the “urgent public health issue.”
By Nick Paul Taylor • July 21, 2022 -
Sarah Silbiger via Getty Images
Smiths Medical's recall of syringe infusion pumps labeled Class I event after injuries, death
The company is asking customers to return devices if abnormal circuit board behavior causes the pump to stop.
By Nick Paul Taylor • July 21, 2022 -
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FDA patient advisers grapple with consent, oversight of virtual-reality devices in healthcare
The advisory group addressed patient consent in surgeries using augmented reality tools and how to distinguish clinical uses of virtual reality from entertainment products.
By Elise Reuter • July 20, 2022 -
Sarah Silbiger via Getty Images
Defibrillators, chest drains added to FDA's list of device shortages
The defibrillator supply disruption reflects both increased demand and problems sourcing a component, part or accessory.
By Nick Paul Taylor • July 20, 2022 -
Carl Court via Getty Images
Notified bodies have yet to issue MDR certificates for 85% of legacy devices: survey
The EU's Medical Device Regulation certification process is taking twice as long as the old directive pathway and smaller companies are struggling to get started, the poll shows.
By Nick Paul Taylor • July 18, 2022 -
Sarah Silbiger via Getty Images
FDA faces furloughs if Senate misses August deadline for user fee bill
If legislation isn’t passed before the August recess, the FDA would have to furlough workers, slowing its review of medical device and pharmaceutical products.
By Elise Reuter • July 15, 2022 -
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Medtronic warns European healthcare providers of safety problem in defibrillators
The warning adds to Medtronic’s growing list of product safety issues over the last 18 months.
By Ricky Zipp • July 15, 2022 -
Permission granted by Columbia University
Q&AFriday Q&A: Ian Lipkin, Columbia epidemiologist, talks COVID-19 testing as U.S. sees another wave
Lipkin explained why he’s not a fan of antigen tests, and stressed the need to keep PCR testing a core part of the pandemic response.
By Elise Reuter • July 15, 2022 -
Permission granted by DarioHealth
Lack of payment pathway clarity hinders digital therapeutics, analysts say
The report warns of a sector beset by payment issues, “snake oil” and “middling adoption.”
By Nick Paul Taylor • July 15, 2022 -
artJazz via Getty Images
EC publishes IVDR guidance in absence of completed Eudamed database
The commission recently announced a timeline for complete implementation of Eudamed, aiming for the second quarter of 2024.
By Ricky Zipp • July 13, 2022 -
Pablo Blazquez Dominguez via Getty Images
Quest launches monkeypox PCR test as U.S. attempts to catch up with rising cases
The company estimates it will be able to process 30,000 tests per week by the end of July. As of July 12, there were 929 confirmed cases in the U.S., the CDC reported.
By Ricky Zipp • July 13, 2022 -
Courtesy of Abbott
Abbott gets FDA breakthrough tag for deep brain stimulation system in depression
The breakthrough device designation builds on a series of clinical trials of other systems that have yielded mixed results.
By Nick Paul Taylor • July 13, 2022 -
Alex Wong via Getty Images
CMS makes 'market-moving proposals' to some medtech Medicare rates, say analysts
BTIG analysts warned in a recent report that the changes “might curtail usage of some higher-dollar” medical devices.
By Nick Paul Taylor • July 12, 2022 -
Carl Court via Getty Images
European Commission targets spring of 2024 for fully functional Eudamed database
The Commission is planning a two-phase transition to mandatory use of the database after it goes live.
By Nick Paul Taylor • July 11, 2022 -
Medtronic recalls over 1M dialysis catheters due to malfunction
The recall is the latest in a growing list of product safety issues for Medtronic, including Class I recalls and an FDA warning letter for its diabetes unit.
By Ricky Zipp • July 11, 2022 -
Chip Somodevilla via Getty Images
Ex-Mazor executive charged by SEC with insider trading over Medtronic's $1.6B buyout
Doron Tavlin, who was Mazor’s vice president of business development, is accused by the agency of profiting from his inside knowledge of the pending takeover.
By Nick Paul Taylor • July 11, 2022 -
Permission granted by iRhythm Technologies
CMS proposes national rates for cardiac monitoring; iRhythm's stock jumps
The proposed rule could end a years-long saga for the cardiac market, although pricing specifics may change in the final version.
By Ricky Zipp • July 8, 2022 -
Carl Court via Getty Images
High-risk IVD tests rules finalized by European Commission despite industry calls for change
MedTech Europe pushed back against some of the requirements, but the Commission has retained disputed parts of the document.
By Nick Paul Taylor • July 8, 2022 -
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Getinge recalls anesthesia machines due to cracked, broken suction power switches
The FDA labeled the recall a Class I event, marking Getinge’s fifth Class I recall since September.
By Ricky Zipp • July 7, 2022 -
Courtesy of Bose
Senators press FDA to finalize OTC hearing aids, accuse industry of 'astroturf' campaigns
The two cross-aisle politicians said they want to “expand access, reduce costs, and ensure a robust new market for safe and effective OTC hearing aids” and accused the device manufacturing lobby of “harming American consumers.”
By Elise Reuter • July 6, 2022 -
Sarah Silbiger via Getty Images
American Contract Systems' COVID-19 test recall gets Class I label from FDA
Off-site assembly by workers who may not have been properly trained prompted the company to recall COVID-19 tests amid concerns they may yield false results.
By Nick Paul Taylor • Updated July 6, 2022
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