Top device firms report safety data late: BMJ

BD, Medtronic and Abbott were among the top 10 device companies with the highest number of late reports to the FDA, the study found.

By Elise Reuter • March 18, 2025

FDA adds hemodialysis devices to shortage list amid B. Braun disruption

The disruption is expected to impact patient care, may require adjustments to the management of hemodialysis patients and could continue through the early fall of 2025.

By Nick Paul Taylor • March 17, 2025

J&J’s Monarch robot wins FDA nod for AI software update

Using Nvidia and GE Healthcare technology, the robotic surgery system is intended to help doctors detect lung cancer earlier.

By Susan Kelly • March 13, 2025

FDA accuses Mid-Link of copying or falsifying medical device test data

The agency will reject all data from the Chinese service provider’s studies after Mid-Link failed to address concerns outlined in a warning letter last year, FDA officials said.

By Nick Paul Taylor • March 12, 2025

Douglas Kelly, deputy science director at FDA’s device center, leaves agency

Kelly, who made several key hires at the CDRH and helped negotiate the last user fee agreement, announced his departure in a LinkedIn post Sunday.

By Elise Reuter • March 11, 2025

The top 3 impacts of Trump’s health data purge

Interrupted access to health-related data has already led to worse outcomes and could undermine faith in the U.S. healthcare system, experts say.

By Michael Brady • March 10, 2025

New FDA pulse oximetry guidelines could stall under Trump

The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones. Experts raised concerns that it might not be finalized.

By Elise Reuter • March 10, 2025

Dexcom receives warning letter based on FDA inspections of 2 plants

The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek clearance for new products.

By Nick Paul Taylor • March 10, 2025

Following FDA cuts, Trump nominee Makary vows ‘independent’ staff review

The Johns Hopkins surgeon highlighted rapid growth at the agency, but pledged key staff will have “all the resources they need to do their job well.”

By Jonathan Gardner • March 6, 2025

Makary, under review to run FDA, evades pressure to reinstate canceled vaccine meeting

Questioned by senators at a Thursday hearing, President Donald Trump's FDA nominee said he would reevaluate which scientific topics require an advisory committee's input.

By Ned Pagliarulo • March 6, 2025

Trump administration policies could create headwinds across healthcare: Fitch

The credit ratings agency is most concerned about Medicaid cuts and how government layoffs will affect device approvals.

By Susanna Vogel • March 5, 2025

Philips pulls endovascular implant from market after 20 injuries

Philips stopped selling its Tack endovascular system because of cases where additional interventions were needed to remove the implant.

By Elise Reuter • March 5, 2025

FDA recall notice details J&J pause of Varipulse

Four of the 132 patients treated with Varipulse in the first two months of the U.S. launch had a form of stroke shortly after surgery.

By Nick Paul Taylor • March 3, 2025

Tandem’s insulin pump tech wins FDA nod for Type 2 diabetes

Tandem is following competitor Insulet’s lead with the second automated insulin delivery system indicated for Type 2 diabetes.

By Elise Reuter • Feb. 27, 2025

‘Fear and uncertainty’: Biotech investors warn of impact from NIH research cuts

The Trump administration’s plans to reduce NIH grant funding could have long-term consequences for the U.S. drug industry, investors said.

By Gwendolyn Wu • Feb. 27, 2025

CAP urges HHS to revoke lab developed test rule, citing Trump order

The pathologists group wants the regulation terminated in light of an executive order from President Trump that calls for federal agencies to “alleviate unnecessary regulatory burdens.”

By Nick Paul Taylor • Feb. 26, 2025

FDA brings back some fired device staff

An industry source said “most, if not all” of the people at the CDRH who were recently dismissed are now being asked to return.

By Elise Reuter • Feb. 24, 2025

Medtronic gains FDA OK for self-adjusting DBS system for Parkinson’s

The brain-computer interface technology personalizes therapy based on an individual’s brain activity.

By Susan Kelly • Feb. 24, 2025

In FDA job cuts, experts see threat of far-reaching impact

"Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency commissioner Robert Califf.

By Jonathan Gardner , Delilah Alvarado • Feb. 21, 2025

Device industry scrambles as FDA job cuts cause delays

The cuts at the FDA’s device center could add “months, if not years” to the time it takes to bring products to market, an attorney said.

By Elise Reuter • Feb. 20, 2025

Medtronic nears FDA submission for Hugo robot

CEO Geoff Martha said Medtronic would submit its application for urological procedures to the Food and Drug Administration by the end of March.

By Ricky Zipp • Feb. 18, 2025

RFK Jr. confirmed as HHS secretary

Robert F. Kennedy Jr., a prominent vaccine critic, was confirmed Thursday by the U.S. Senate in a 52-48 vote to serve as the nation’s top health official.

By Emily Olsen • Feb. 13, 2025

Judge orders FDA, health agencies to restore removed webpages

District Judge John Bates wrote the removals harm “everyday Americans, and most acutely, underprivileged Americans, seeking healthcare.”

By Elise Reuter • Feb. 12, 2025

Trump orders agencies to plan for ‘large-scale’ job cuts

While Trump’s executive order provides substantial power to Elon Musk’s DOGE effort, it’s not specifically targeted to health agencies like the FDA.

By Ned Pagliarulo • Feb. 12, 2025

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