FDA
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Elise Reuter/MedTech Dive
Tarver warns that US device supply chain vulnerabilities could harm patients
The new director of the FDA’s device center contrasted a European rule with the lack of mandatory reporting requirements for potential device shortages in the U.S.
By Nick Paul Taylor • Jan. 17, 2025 -
Retrieved from Hologic on January 16, 2025
Hologic receives FDA warning letter over Biozorb implantable markers
Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.
By Elise Reuter • Updated Jan. 16, 2025 -
Explore the Trendline➔
Sitthiphong via Getty Images
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 -
Patrik Stollarz / Staff via Getty Images
Philips recall of heart monitor software tied to 109 injuries, 2 deaths
Some electrocardiogram events, such as atrial fibrillation or abnormally rapid heartbeats, over two years were not reviewed by healthcare professionals due to a data routing issue.
By Ricky Zipp • Jan. 14, 2025 -
Courtesy of Intuitive Surgical
Deep Dive // 2025 outlook5 medtech trends to watch in 2025
After a busy 2024, experts called out competition in soft tissue robotics, uncertainty from a Trump White House and continued success for pulsed field ablation as trends to watch this year.
By Ricky Zipp • Jan. 9, 2025 -
Sarah Silbiger via Getty Images
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FDA aims to stem AI device bias, boost transparency in draft guidance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 -
Wavebreakmedia via Getty Images
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 recalls Accolade pacemakers tied to 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 • Dec. 17, 2024 -
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 when President-elect Donald Trump returns 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
