FDA: Page 2
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FDA prioritizes guidance on lab developed tests in 2025 plan
The Center for Devices and Radiological Health intends to develop final guidance on its enforcement discretion policy regarding special controls for LDTs, among other topics.
By Nick Paul Taylor • Oct. 18, 2024 -
Courtesy of Cue Health Press Kit
FDA labels Cue’s recall of COVID tests as Class II, revokes EUAs
Cue Health began the recall of nearly 250,000 COVID-19 test kits in May, shortly after the FDA advised people at home and healthcare professionals not to use the products.
By Nick Paul Taylor • Oct. 17, 2024 -
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Medical 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 -
Elise Reuter/MedTech Dive
The Medtech ConferenceLegacy medical devices keep regulators up at night
The FDA’s Suzanne Schwartz said at The Medtech Conference that addressing legacy devices is a “work in progress” and a problem regulators and industry need to work on together.
By Elise Reuter • Oct. 17, 2024 -
Win McNamee via Getty Images
Health officials outline industry role in AI oversight in JAMA article
FDA Commissioner Robert Califf and two colleagues warned that the “scale of effort” needed to repeatedly evaluate AI models “could be beyond any current regulatory scheme.”
By Nick Paul Taylor • Oct. 16, 2024 -
Elise Reuter/MedTech Dive
The Medtech ConferenceFDA, Health Canada give sneak peek into future AI regs
Canada’s device agency plans to issue guidance on machine learning, and the FDA plans to release a draft guidance next year on lifecycle management and premarket submissions for AI devices.
By Elise Reuter • Oct. 16, 2024 -
Courtesy of Medtronic
Medtronic to evaluate Affera in ventricular tachycardia
The FDA approved an early feasibility study of Medtronic’s Affera mapping and ablation system and Sphere-9 catheter in patients with ventricular tachycardia, an abnormal heart rhythm.
By Susan Kelly • Oct. 15, 2024 -
Courtesy of Metro Toronto Convention Centre
The Medtech Conference4 trends to watch at Advamed’s The Medtech Conference
As medtech companies, experts and regulators gather in Toronto, FDA leadership changes and the upcoming U.S. presidential election loom over the industry.
By Elise Reuter • Oct. 14, 2024 -
Retrieved from Aerial Lens on October 10, 2024
Baxter ups IV fluid allocations amid supply shortages
As hospitals around the U.S. report IV fluid shortages, Baxter has increased supply allocations for direct customers and distributors. It plans on returning to 90% to 100% allocation of certain supplies by the end of 2024.
By Ricky Zipp • Oct. 10, 2024 -
Courtesy of Procept Biorobotics
Procept secures FDA approval to study surgical robot in prostate cancer
The trial will compare the therapy to radical prostatectomy and could unlock a market that analysts value at $500 million.
By Nick Paul Taylor • Oct. 9, 2024 -
Sarah Silbiger via Getty Images
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 -
FG Trade via Getty Images
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
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