FDA: Page 5
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Courtesy of Intuitive Surgical
2025 outlookTop medtech trends in 2025: New products and M&A are bright spots, but Trump brings uncertainty
Experts highlighted surgical robotics, artificial intelligence and M&A as top trends this year. However, the Trump administration could create challenges for the industry.
By Ricky Zipp • Jan. 31, 2025 -
Sarah Silbiger via Getty Images
FDA warns about patient monitor cybersecurity vulnerabilities
Vulnerabilities in certain Contec and Epsimed patient monitors can allow people to gain access and potentially manipulate the devices, the FDA warned.
By Nick Paul Taylor • Jan. 31, 2025 -
Explore the Trendlineâž”
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Retrieved from Screenshot: The Food and Drug Administration.
FDA webpages on clinical trial diversity removed after Trump orders
The website changes raise concerns about “the interference of politics with the study and the practice” of science and medicine, a physician said.
By Elise Reuter • Jan. 27, 2025 -
Sarah Silbiger via Getty Images
Sara Brenner named acting FDA commissioner
Brenner, who worked in the FDA’s Center for Devices and Radiological Health, will take the helm of the agency until a new leader is confirmed.
By Elise Reuter • Jan. 24, 2025 -
Rebecca Noble via Getty Images
Senate sets date to vet RFK Jr.’s nomination to lead HHS
The Senate Finance Committee will meet on Jan. 29 to discuss the confirmation of RFK Jr., whose stances on vaccines and abortion have raised questions from Democrats and Republicans alike.
By Kristin Jensen • Jan. 23, 2025 -
Retrieved from Mass General Brigham on January 22, 2025
Deep Dive // 2025 outlookAI in medtech is taking off. Here are 4 trends to watch in 2025.
New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain around insurance coverage and generative AI.
By Elise Reuter • Jan. 22, 2025 -
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 -
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 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
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