FDA: Page 21
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Permission granted by iRhythm Technologies
FDA hits iRhythm with warning letter over problems at heart monitor facility
iRhythm can continue to manufacture and sell its products and does not expect the warning letter to materially affect its financial results.
By Nick Paul Taylor • June 1, 2023 -
deliormanli via Getty Images
Patient advocacy groups urge FDA to regulate lab-developed tests if VALID Act doesn’t pass
Legislation has been proposed in Congress to bring diagnostic tests under a single regulatory framework, but if it doesn’t pass, the FDA has authority to regulate lab-developed tests, the groups said.
By Elise Reuter • May 31, 2023 -
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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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MedTech Europe sets out position on cybersecurity, making case for reliance on MDR
As the number of connected medical devices grows, the industry group argues that Europe’s new medtech regulations should remain “the primary avenue” for medical device cybersecurity.
By Nick Paul Taylor • Updated June 12, 2023 -
Courtesy of Grail
Illumina accused of ‘playing delay tactics’ to push back EU decision on divesting Grail: Financial Times
Delaying the decision to divest Grail could let Illumina sell the liquid biopsy business when the market is more favorable.
By Nick Paul Taylor • May 30, 2023 -
Permission granted by Josh Makower
Q&AFriday Q&A: Stanford Biodesign’s Makower on expediting Medicare coverage for breakthrough devices
The director and co-founder of the Stanford Byers Center for Biodesign has been urging CMS to get patients access to breakthrough devices.
By Susan Kelly • Updated May 26, 2023 -
Courtesy of Boston Scientific
Boston Scientific cancels $230M stent deal after regulators erect barriers to acquisition
The Federal Trade Commission said Boston Scientific took the action in response to investigations by its staff and overseas enforcement partners.
By Nick Paul Taylor • May 26, 2023 -
Scott Olson via Getty Images
FDA teams with Veterans Health Administration to make medtech supply chains more resilient
Rather than amassing reserves of physical supplies, “digital stockpiles” would create a network of trusted suppliers that have the ability to make products at or near the point of use.
By Nick Paul Taylor • May 24, 2023 -
Boris Jovanovic via Getty Images
Beta Bionics wins FDA nod to challenge Medtronic for automated insulin pump market
Beta Bionics’ device, aimed at people with Type 1 diabetes, has eliminated most of the data entry required by competitors.
By Nick Paul Taylor • May 22, 2023 -
Retrieved from Istock.
Thermo Fisher gets FDA clearance for first blood test of severe preeclampsia risk
A study found the test is a better predictor of the risk of developing preeclampsia with severe features than standard clinical measures.
By Nick Paul Taylor • May 22, 2023 -
Carol Highsmith. (2005). "The Apex Building" [Photo]. Retrieved from Wikimedia Commons.
FTC moves to strengthen Health Breach Notification Rule’s applicability to digital health apps
Regulators are increasingly leaning on the HBNR to crack down on the sharing of sensitive medical data, and the FTC is looking to strengthen its case.
By Rebecca Pifer • May 18, 2023 -
ArtemisDiana via Getty Images
Rapid AI adoption could cause medical errors, patient harm, WHO warns, urging oversight
Warning that caution is not being exercised with use of artificial intelligence in healthcare, the World Health Organization called for rigorous oversight of the new technology.
By Susan Kelly • May 17, 2023 -
Courtesy of Abbott Laboratories
Abbott wins FDA spinal cord stimulation approval to challenge Nevro for back pain market
The label expansion comes 16 months after Nevro won FDA approval in non-surgical refractory back pain and four months after Boston Scientific released data on its rival device.
By Nick Paul Taylor • Updated May 17, 2023 -
Gromit702/iStock/Getty Images Plus via Getty Images
AdvaMed cites EPA’s own impact assessment to push back against ethylene oxide proposals
Medtech firms and environmental regulators are at loggerheads as the industry looks for a safe and cost-effective alternative to ethylene oxide for sterilizing reusable devices.
By Nick Paul Taylor • May 12, 2023 -
Courtesy of Hologic
New breast cancer screening guidelines could boost mammography sales
Hologic, which makes mammography machines, could see an increase in its installed base, according to Needham analysts.
By Elise Reuter • May 9, 2023 -
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FDA calls for ‘nimble’ regulation of ChatGPT-like models to avoid being ‘swept up quickly’ by tech
The head of the agency said the models are “ushering in the revolution that many of us were hoping for,” but cautioned that the sector will need to be regulated appropriately.
By Nick Paul Taylor • May 9, 2023 -
Mark Wilson via Getty Images
Boston Scientific gets DOJ subpoena for documents related to heart monitoring
The disclosure comes as cardiac monitoring device maker iRhythm also said it received a request from the Justice Department.
By Susan Kelly • May 5, 2023 -
Drew Angerer/Getty Images via Getty Images
CDC Director Walensky to step down in June
Rachel Walensky, who has served as director since 2001, was criticized for the federal government’s handing of the pandemic, announcing in August last year that she planned to reorganize the CDC.
By Sydney Halleman • May 5, 2023 -
Sarah Silbiger via Getty Images
FDA posts draft guidance on studying medical devices in decentralized clinical trials
Analysts at Cowen said the draft could reassure sponsors they can run decentralized trials without complicating approvals.
By Nick Paul Taylor • May 4, 2023 -
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Great Britain proposes allowing CE marks until 2030 to minimize Brexit disruption
The extended timeline to create a new regulatory system in England, Scotland and Wales is intended to prevent medical device shortages.
By Nick Paul Taylor • May 1, 2023 -
Courtesy of Illumina
Illumina gets cybersecurity warning from FDA over sequencing software
The vulnerability could result in an attacker gaining control of an instrument remotely and altering genomic data results, the agency said.
By Susan Kelly • Updated April 28, 2023 -
Courtesy of Medtronic
Medtronic diabetes warning letter lifted by FDA
The resolution will allow Medtronic to bring new products to market faster, such as its new continuous glucose monitor, Simplera.
By Elise Reuter • April 25, 2023 -
Courtesy of Medtronic
Medtronic wins FDA approval for long-delayed MiniMed 780G insulin pump
Analysts called the FDA approval a “positive” for Medtronic that “should somewhat aid in a turnaround of its U.S. diabetes franchise.”
By Nick Paul Taylor • April 24, 2023 -
Michaela Wong/MedTech Dive
Supreme Court maintains access to abortion pill, blocking restrictions on its use
The decisions stayed by the Supreme Court could affect future challenges to the FDA’s authority to regulate drugs and medical devices.
By Delilah Alvarado • Updated April 22, 2023 -
Andrii Yalanskyi via Getty Images
Report names connected medical devices with the biggest cybersecurity risks
The findings come as medical device makers face upcoming FDA requirements for providing cybersecurity information as part of their pre-market submissions.
By Nick Paul Taylor • April 21, 2023 -
Dragan991 via Getty Images
OpinionEnding free COVID tests risks worsening the pandemic
If Americans start paying out of pocket for COVID tests, they'll test much less — if at all, argue representatives of the Testing at Home Coalition.
By Amy Kelbick and Eric Zimmerman • April 20, 2023
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