FDA posts early alert about BD device linked to 30 injuries, 4 deaths

The alert was posted one day after BD sent customers a letter warning about the risk of atherectomy catheters breaking.

By Nick Paul Taylor • Feb. 10, 2025

Medtronic recall of brain fluid drainage systems linked to 15 injuries

The company will keep the systems on the market but is asking providers to check devices for visible cracks and return affected devices.

By Nick Paul Taylor • Feb. 4, 2025

Explore the Trendline➔

Medical 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

RFK Jr. clears key hurdle on path to HHS secretary

A key Senate committee voted to advance Robert F. Kennedy’s nomination even after some legislators raised concerns about his previous vaccine stances and confusion surrounding programs like Medicare and Medicaid.

By Sydney Halleman , Delilah Alvarado , Jonathan Gardner • Feb. 4, 2025

FDA labels recall of discontinued Olympus endoscope part as Class I

The update comes about six weeks after an early alert flagged reports of 120 injuries and one death linked to reprocessing of the device.

By Susan Kelly • Feb. 3, 2025

Troy Tazbaz, CDRH digital health leader, resigns

Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading key policies on artificial intelligence and software as a medical device.

By Elise Reuter • Jan. 31, 2025

Top 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

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

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

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

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

AI 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

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

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

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

5 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

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

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

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

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

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

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

Few 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

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

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

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