FDA: Page 4
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FDA finalizes guidance on device shortage reporting rules
The final version adds information on the devices affected by the guidance and the impact of revised legislation on voluntary notifications.
By Nick Paul Taylor • Jan. 8, 2025 -
Elise Reuter/MedTech Dive
FDA aims to stem AI device bias, boost transparency in draft guidance
The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI devices.
By Elise Reuter • Jan. 7, 2025 -
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 issues much-anticipated guidance on pulse oximeters
The FDA released the guidance in response to concerns that the devices are less accurate in people with darker skin pigmentation.
By Elise Reuter • Jan. 6, 2025 -
Sarah Silbiger via Getty Images
FDA posts early alert about safety risk of Medline’s fluid delivery sets
The agency issued the alert as part of a pilot to improve the timeliness of communications about actions it believes are likely to be high-risk recalls.
By Nick Paul Taylor • Jan. 6, 2025 -
Stock via Getty Images
FDA closes 2024 with string of early alerts on device safety risks
Olympus advised providers to stop using an endoscope accessory due to an infection risk linked to 120 injuries and one death.
By Susan Kelly • Jan. 3, 2025 -
Aleksandr Grechanyuk via Getty Images
FDA-commissioned review finds no safety concerns linked to tampons
Officials commissioned the independent review in September in response to a study that found tampons may expose users to metals.
By Nick Paul Taylor • Jan. 3, 2025 -
Permission granted by Children's National Hospital
Q&AFew medical devices are designed for children. An FDA-Children’s National collaboration aims to change that.
Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the many challenges with developing devices for children and infants.
By Elise Reuter • Jan. 2, 2025 -
Permission granted by CMR Surgical
Robots, AI and PFA: The top medtech Q&As of 2024
From challenging market leaders to the growing influence of artificial intelligence, medical device executives had a lot to discuss this year. Check out MedTech Dive’s top Q&As of 2024.
By Ricky Zipp • Dec. 20, 2024 -
Permission granted by Becton Dickinson
BD receives FDA warning letter over quality system violations
Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety complaints were also listed that BD didn’t report within the required timeframe.
By Nick Paul Taylor • Dec. 20, 2024 -
N/A via Getty Images
Medical device recalls under the spotlight in 2024
Medtech regulators and watchdogs took a closer look at recalls in 2024. Here’s a recap of notable recalls and product safety actions in the past year.
By Elise Reuter • Dec. 19, 2024 -
Courtesy of Boston Scientific
Boston Scientific updates cryoablation catheter instructions after 4 death reports
The update followed a higher than expected number of reports of esophageal injury after catheter ablation procedures for atrial fibrillation.
By Nick Paul Taylor • Dec. 19, 2024 -
Justin Sullivan via Getty Images
Trump’s return to office brings uncertainty for medtech industry
With about one month before inauguration day, check out a roundup of MedTech Dive’s coverage on what President-elect Donald Trump’s new administration means for medical device companies.
By Ricky Zipp • Dec. 18, 2024 -
Sarah Silbiger via Getty Images
Namandjé Bumpus, FDA’s No. 2 official, to depart agency at end of year
Bumpus replaced agency veteran Janet Woodcock as principal deputy commissioner in February 2024. She was previously the FDA’s chief scientist.
By Ned Pagliarulo • Dec. 17, 2024 -
Courtesy of Boston Scientific
Boston Scientific pacemaker recall tied to 832 injuries, 2 deaths
Certain Accolade pacemakers can permanently enter safety mode, which limits the devices’ ability to treat patients properly and requires early replacement.
By Ricky Zipp • Updated Feb. 25, 2025 -
Permission granted by Zimmer Biomet
Zimmer receives FDA nod for stemless shoulder implant
The Osseofit devices are intended to match patients’ shoulder bone anatomy and preserve healthy bone in total shoulder replacement procedures.
By Elise Reuter • Dec. 16, 2024 -
Sarah Silbiger via Getty Images
Q&ACDRH cyber official on compliance with new rules, ongoing security threats
Nastassia Tamari discussed compliance with new device cybersecurity requirements, the risks of legacy devices and frequent cyberattacks in healthcare.
By Ricky Zipp • Updated Dec. 17, 2024 -
Leon Neal / Staff via Getty Images
4 takeaways from the FDA’s first digital health advisory committee
Industry and patient representatives debated how the FDA should regulate generative AI in medical devices and address new challenges with the technology, such as the use of complex models that can change quickly.
By Elise Reuter • Dec. 12, 2024 -
Chip Somodevilla via Getty Images
How Trump’s second term will affect the medtech industry
From M&A and tariffs to new health leaders, here are the top issues for the medtech industry to watch during President Donald Trump’s return to office.
By Ricky Zipp • Dec. 10, 2024 -
Sarah Silbiger via Getty Images
FDA issues final guidance on postmarket updates to AI-enabled devices
By using pre-determined change control plans, manufacturers can update AI-enabled devices without filing an additional FDA submission.
By Elise Reuter • Dec. 4, 2024 -
Permission granted by Movano Health
Movano receives FDA nod for smart ring’s pulse oximeter feature
Movano Health plans to market the Evie Ring to organizations that run clinical trials and healthcare companies that are helping patients manage chronic diseases.
By Nick Paul Taylor • Dec. 3, 2024 -
Noam Galai via Getty Images
Advamed CEO stresses need for safety, efficacy after Trump picks Makary to lead FDA
Martin Makary, a Johns Hopkins surgeon and researcher, has been critical of the FDA. He could have the most influence over device policy among Trump’s nominees.
By Ricky Zipp • Nov. 27, 2024 -
gorodenkoff via Getty Images
Zimmer wins FDA approval for cementless partial knee implant
The device is established in Europe, where the company said it has a 60% market share, but will be the first product of its type available in the U.S.
By Nick Paul Taylor • Nov. 26, 2024 -
Noam Galai via Getty Images
Johns Hopkins surgeon Makary is Trump’s pick to lead FDA
A prolific medical researcher and author, Martin Makary criticized the FDA and CDC for their decision-making during the pandemic, although he describes himself as pro-vaccine.
By Jonathan Gardner , Ned Pagliarulo • Nov. 24, 2024 -
Courtesy of Medtronic
Medtronic nets FDA nod for smart insulin pen app
The clearance paves the way for the launch of Medtronic’s Smart MDI system, which combines its InPen and Simplera continuous glucose monitor for people who take multiple daily insulin injections.
By Susan Kelly • Nov. 22, 2024 -
Sarah Silbiger via Getty Images
FDA plan would alert public sooner on high-risk device recalls
The Center for Devices and Radiological Health’s pilot program is meant to cut the time between the FDA’s awareness of potentially high-risk recalls and when the public is notified.
By Ricky Zipp • Nov. 22, 2024
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