FDA: Page 8
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Courtesy of Grail
Illumina avoids fine for Grail purchase in European court victory
Illumina will avoid a penalty of 432 million euros after a court ruled the European Commission did not have jurisdiction to challenge the company’s Grail acquisition.
By Susan Kelly • Sept. 3, 2024 -
Win McNamee/Getty Images via Getty Images
ARPA-H program to focus on AI degradation in medical tools
The agency will fund work to identify and auto-correct AI-enabled tools that are misaligned with their underlying training data.
By Nick Paul Taylor • Sept. 3, 2024 -
Sarah Silbiger via Getty Images
FDA finalizes Voluntary Malfunction Summary Reporting guidance
The agency clarified when companies can submit device malfunction reports in a quarterly summary, instead of individual reports every 30 days.
By Nick Paul Taylor • Aug. 30, 2024 -
Courtesy of Boston Scientific
Boston Scientific receives CE mark for updated TAVR technology
Changes include the addition of a larger valve size that company executives have said will open up 25% of the market in Europe.
By Nick Paul Taylor • Aug. 28, 2024 -
Courtesy of Illumina
Illumina wins FDA approval for companion diagnostic cancer test
Physicians can use the test to identify people eligible for treatment with Bayer’s Vitrakvi and Eli Lilly’s Retevmo, which target cancers that have specific genetic features.
By Nick Paul Taylor • Aug. 28, 2024 -
Sarah Silbiger via Getty Images
FDA seeks feedback on predetermined change control plans
The guidance describes changes companies can make to medical devices without filing a new 510(k) or premarket approval supplement.
By Nick Paul Taylor • Aug. 26, 2024 -
Courtesy of Procept Biorobotics
Procept wins FDA clearance for updated prostate surgery robot
Procept Biorobotics has added AI capabilities and switched to a single-use scope to support mass-market adoption.
By Nick Paul Taylor • Aug. 22, 2024 -
Permission granted by Peyton Helbert / AAMI
FDA defends Shuren’s tenure after report raises ethics concerns
The FDA backed Jeff Shuren, the agency’s former device leader, amid questions raised by The New York Times. Still, a spokesperson said the FDA has advised Shuren to take greater caution in managing recusal obligations.
By Susan Kelly • Aug. 22, 2024 -
"Government Accountability Office Building" by kafka4prez is licensed under CC BY-SA 2.0
FDA’s plan to expand device surveillance faces challenges, GAO finds
Funding issues and limited use of unique device identifiers are hurdles to expanding an FDA system to monitor medical device safety, the federal watchdog said.
By Nick Paul Taylor • Aug. 21, 2024 -
Courtesy of NowDiagnostics
FDA OKs first at-home syphilis test
NowDiagnostics’ over-the-counter test can return results in 15 minutes with a single drop of blood.
By Ricky Zipp • Aug. 19, 2024 -
Courtesy of Boston Scientific
Boston Scientific resubmits Silk Road merger filing, giving FTC more review time
A Boston Scientific spokesperson said the company still expects to close its $1.26 billion purchase of Silk Road Medical in the second half of the year.
By Ricky Zipp • Aug. 16, 2024 -
Erin Scott / U.S. White House. Retrieved from Flickr.
Biden pledges $150M for medical tech to improve cancer surgery
Awards include funding for microscopy and imaging tools to help surgeons ensure all cancer is removed during a procedure.
By Elise Reuter • Aug. 16, 2024 -
Retrieved from Globus Medical on August 14, 2024
Globus receives warning letter over spine navigation robot
The FDA said Globus delayed reporting complaints about misplaced screws, despite information that “reasonably suggests” the Excelsius GPS system malfunctioned.
By Nick Paul Taylor • Aug. 14, 2024 -
Courtesy of Medtronic
Medtronic wins FDA approval for asleep deep brain stimulation
Medtronic said Monday it is the first company to receive FDA approval to offer DBS surgery while a patient is asleep or awake.
By Nick Paul Taylor • Aug. 13, 2024 -
Rebecca Pifer/MedTech Dive
CMS finalizes notice on Medicare coverage for breakthrough devices
Through the new pathway, called Transitional Coverage for Emerging Technologies, the CMS will consider five medical device candidates yearly for national coverage.
By Elise Reuter • Aug. 8, 2024 -
Sarah Silbiger via Getty Images
FDA seeks feedback on health equity for medical devices
The agency plans to develop a framework for when devices should be evaluated in diverse populations to support marketing authorization.
By Nick Paul Taylor • Aug. 6, 2024 -
Courtesy of Labcorp
Labcorp wins FDA OK for pan-solid tumor liquid biopsy
Shakti Ramkissoon, Labcorp’s medical lead for oncology, said the test could allow laboratories and oncologists to profile solid tumors when tissue samples are limited or unavailable.
By Nick Paul Taylor • Aug. 6, 2024 -
Courtesy of Inspire Medical Systems
Inspire wins FDA approval for obstructive sleep apnea neurostimulator therapy
Inspire plans to start a soft launch of the device late in 2024 and move into a full release in 2025.
By Nick Paul Taylor • Aug. 5, 2024 -
Karen Ducey/Getty Images via Getty Images
Experts fear patient harm from FDA’s lab developed test rule
Decreased access to diagnostic tests, worsening patient care and practice closures are among the concerns the AMA and others have raised as the regulation takes effect.
By Susan Kelly • Aug. 5, 2024 -
Courtesy of Johnson & Johnson
J&J launches Velys Spine surgical robotics and navigation platform
With its Velys surgical robotics portfolio, J&J aims to take market share from competitors Stryker and Zimmer Biomet.
By Nick Paul Taylor • Aug. 5, 2024 -
Courtesy of Johnson & Johnson
FDA, Health Canada team up to raise awareness of J&J’s Megadyne recall
Agency officials are working together to communicate the risk of burns tied to Megadyne electrode pads.
By Nick Paul Taylor • Aug. 1, 2024 -
Sarah Silbiger via Getty Images
FDA sends warning letter to defibrillator battery manufacturer
Amco makes batteries for automated external defibrillators sold by companies including Philips, Stryker and Zoll.
By Nick Paul Taylor • July 31, 2024 -
Joe Raedle via Getty Images
Patient shares a day in the life with diabetes at FDA’s first Home Health Hub meeting
The initiative, led by new CDRH Acting Director Michelle Tarver, is intended to improve health equity by including people’s living conditions in device design.
By Elise Reuter • July 30, 2024 -
Sarah Silbiger via Getty Images
FDA officials outline benefits of AI lifecycle management
The digital health leaders detailed a seven-stage diagram for how the healthcare industry could monitor artificial intelligence software development.
By Nick Paul Taylor • July 30, 2024 -
Courtesy of Guardant Health
Guardant wins FDA approval for colon cancer blood test
Colorectal cancer screening rates could increase if the Shield test appeals to people who have avoided colonoscopies or stool-based tests, the company said.
By Susan Kelly • July 29, 2024
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