FDA
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Mercury Medical recalls emergency resuscitators
Healthcare professionals use the devices to provide newborns and infants with emergency breathing support.
By Nick Paul Taylor • Oct. 8, 2024 -
Courtesy of Exact Sciences
Exact Sciences wins FDA approval for Cologuard Plus colorectal cancer test
Exact Sciences expects to launch the updated test, which has higher specificity than its predecessor, with Medicare coverage and guideline inclusion in 2025.
By Nick Paul Taylor • Oct. 7, 2024 -
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TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
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Elucid wins FDA 510(k) nod for heart plaque image analysis software
The software turns coronary CT angiography images into 3D models that quantify and classify plaque morphology to improve predictions of heart attack and stroke risk.
By Nick Paul Taylor • Oct. 4, 2024 -
Permission granted by Becton Dickinson
BD agrees to settle most of its hernia mesh litigation
The settlement terms are confidential, BD said. The company disputes the lawsuit’s allegations and backs its product designs.
By Susan Kelly • Oct. 3, 2024 -
Jolygon via Getty Images
FDA authorizes Pi-Cardia’s valve-in-valve TAVR device
Pi-Cardia designed the Shortcut device to mitigate the risk of coronary artery obstruction by splitting aortic valve leaflets before valve placement.
By Nick Paul Taylor • Oct. 3, 2024 -
Courtesy of Siemens Healthineers
Siemens Healthineers wins FDA approval for 3D mammography system
The 3D capabilities are part of Siemens’ first completely redesigned mammography platform in over a decade.
By Nick Paul Taylor • Oct. 2, 2024 -
Stringer via Getty Images
GE Healthcare gets FDA nod for new PET imaging agent
Called Flyrcado, the radiotracer could help improve cardiac imaging accuracy in patients with a high body mass index and women, the company said.
By Susan Kelly • Oct. 1, 2024 -
Sarah Silbiger via Getty Images
Establishment Labs wins FDA approval for Motiva breast implants
Motiva is the first new breast implant to receive premarket approval since 2013, according to Establishment Labs, and enters a market reshaped by safety issues linked to other products.
By Nick Paul Taylor • Sept. 30, 2024 -
Permission granted by Peyton Helbert / AAMI
Lawmakers call for investigation of former FDA device director
The letter to the health department watchdog follows a New York Times report that raised concerns about Jeff Shuren’s potential conflicts of interest as head of the FDA’s device center.
By Elise Reuter • Sept. 26, 2024 -
Sarah Silbiger via Getty Images
FDA proposes reclassifying hepatitis B assays
The FDA plans to move the assays from higher-risk class III devices to class II, making them eligible for the 510(k) pathway.
By Nick Paul Taylor • Sept. 26, 2024 -
Permission granted by FDA
FDA names new head of medical device evaluation and quality
Ross Segan was chosen to lead the office, which handles premarket authorizations and recalls, in the agency’s Center for Devices and Radiological Health.
By Susan Kelly • Sept. 24, 2024 -
Sarah Silbiger via Getty Images
FDA posts draft guidance on biocompatibility testing of devices
To promote consistency and reliability in premarket submissions, the FDA shared approaches for device biocompatibility analysis.
By Nick Paul Taylor • Sept. 23, 2024 -
Courtesy of GE Healthcare
GE Healthcare wins FDA clearance for Alzheimer’s imaging software
The clearance adds a Centiloid scale tool to GE Healthcare’s Mim software to help clinicians determine the density of amyloid plaque.
By Nick Paul Taylor • Sept. 20, 2024 -
Justin Sullivan/Staff via Getty Images
Advamed backs FDA’s misinformation draft, calls for updates on AI and deep fakes
Advamed said the draft guidance “better reflects the wide scope of internet-based content seen in today’s information age” than an earlier version.
By Nick Paul Taylor • Sept. 16, 2024 -
Courtesy of Boston Scientific
Boston Scientific closes Silk Road Medical acquisition
Completion of the purchase comes three months after the companies announced the deal, and after Boston Scientific resubmitted its merger filing to give the FTC more review time.
By Ricky Zipp • Updated Sept. 17, 2024 -
Scott Olson via Getty Images
Apple wins FDA nod for hearing aid software for certain Airpods
Apple is the first company to receive authorization for over-the-counter hearing aid software.
By Nick Paul Taylor • Sept. 13, 2024 -
Sarah Silbiger via Getty Images
FDA warns 2 Chinese labs for oversight failures, animal care violations
The FDA said the problems “raise concerns about the quality and integrity of data generated by the labs,” which provide third-party testing and validation data services for device firms.
By Nick Paul Taylor • Sept. 12, 2024 -
Permission granted by Abbott
Dexcom, Abbott OTC glucose sensors add to busy year for diabetes tech
New over-the-counter sensors, an Abbott-Medtronic partnership and Roche’s first CGM are among diabetes technology’s top stories so far in 2024. Check out MedTech Dive’s roundup of the latest news.
By Ricky Zipp • Sept. 11, 2024 -
Sarah Silbiger via Getty Images
FDA to investigate presence of metals in tampons
Members of the Democratic Women’s Caucus last week urged FDA Commissioner Robert Califf to address the safety concerns.
By Nick Paul Taylor • Sept. 11, 2024 -
Adene Sanchez via Getty Images
Lab group urges lawmakers to rescind FDA final rule on LDTs
A survey found 48% of labs will discontinue LDTs if they do not qualify for an exception under the FDA final rule.
By Nick Paul Taylor • Sept. 9, 2024 -
Retrieved from The Food and Drug Administration.
FDA cracks down on ozone cleaners for CPAP machines
The agency sent warning letters to four companies and reminded the public it has not authorized any devices for cleaning or disinfecting CPAPs.
By Elise Reuter • Sept. 5, 2024 -
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European heart group recommends renal denervation for some patients
The European Society of Cardiology said the treatment may be considered for certain patients with uncontrolled, drug-resistant high blood pressure but outlined lingering concerns.
By Nick Paul Taylor • Sept. 4, 2024 -
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
