FDA schedules first public MDUFA VI meeting ahead of negotiations

Officials want to know what current features should be reduced or stopped to “ensure the continued efficiency and effectiveness of the medical device review process.”

By Nick Paul Taylor • June 11, 2025

Baxter recalls Novum pump linked to 1 serious injury

The company has asked users to monitor patients frequently to ensure the appropriate infusion is being delivered.

By Nick Paul Taylor • Updated 18 hours ago

HHS staffers sue over ‘hopelessly error-ridden’ layoffs

Most of the 10,000 HHS employees let go this spring could qualify for the class, according to lawyers. It’s the latest in a string of litigation against the Trump administration for drastically downsizing the federal workforce.

By Rebecca Pifer • June 5, 2025

Smiths Medical recalls infusion pumps over 3 problems

Smiths has not reported any serious injuries or deaths related to the issues, but the FDA sees a risk of harm. 

By Nick Paul Taylor • June 4, 2025

HHS releases more detailed 2026 budget disclosing scope of cuts

On Friday, the HHS fleshed out a preliminary budget released in the spring and gave new details about which of its programs would be terminated if the Trump administration gets its way.

By Rebecca Pifer • June 2, 2025

Bivacor wins FDA breakthrough nod for titanium total artificial heart

The company has so far treated patients who were weeks or months away from a transplant, but the device is theoretically suitable for longer-term use.

By Nick Paul Taylor • June 2, 2025

Boston Scientific ends TAVR sales; J&J shares Monarch robot data

Boston Scientific said it would halt worldwide sales of its Acurate devices due to “increased clinical and regulatory requirements.”

By Elise Reuter • May 28, 2025

FDA finds Chinese lab copied or falsified data, endangering patients

The FDA said the findings raise doubts about the reliability and viability of premarket submissions based on the company’s data.

By Nick Paul Taylor • May 28, 2025

BD recalls esophagogastric tubes linked to 2 serious injuries, 1 death

A problem when preparing the devices for use can delay diagnosis or treatment, leading BD to update its instructions.

By Nick Paul Taylor • May 27, 2025

Stryker wins FDA clearance for minimally invasive back pain treatment

The company will compete with a device Boston Scientific acquired for $850 million.

By Nick Paul Taylor • May 22, 2025

FDA sets stricter approval standards for COVID vaccines

The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, Commissioner Martin Makary and top vaccine official Vinay Prasad wrote in NEJM.

By Delilah Alvarado • May 20, 2025

FDA clears first blood test to aid Alzheimer’s diagnosis

The FDA cleared the test for the early detection of amyloid plaques associated with Alzheimer’s in people aged 55 years and older with signs and symptoms of the disease.

By Nick Paul Taylor • May 19, 2025

Teal wins FDA approval for at-home cervical cancer screening device

The company plans to start shipping the device in June, starting in California and then expanding nationwide.

By Nick Paul Taylor • May 13, 2025

FDA, aiming to speed scientific reviews, names chief AI officer

Commissioner Martin Makary also said the agency would roll out a generative AI system across its centers that will help FDA scientists spend less time on repetitive tasks.

By Susan Kelly • May 9, 2025

AdvaMed calls for ‘zero for zero’ medtech tariffs between US and UK

AdvaMed and its British counterpart called for urgent action to ensure the situation “does not devolve into a crisis.”

By Nick Paul Taylor • May 7, 2025

State attorneys general sue over ‘unconstitutional’ HHS restructuring

The lawsuit alleges the Trump administration overstepped its authority in reshaping the federal health department and asked the court to reinstate workers laid off last month.

By Susanna Vogel • May 7, 2025

RFK’s FDA layoffs could slow safety communications, experts warn

The mass cuts, which included communications staff, could slow public notices on medical device recalls and other safety alerts.

By Elise Reuter • May 6, 2025

Edwards gains expanded TAVR label for asymptomatic patients

The medical technology company expects the new indication to increase sales in its transcatheter aortic valve replacement business with more patients becoming eligible for the treatment.

By Susan Kelly • May 5, 2025

Trump policies are upending healthcare. Track the effect on the medtech industry here.

The FDA has rolled out an AI tool agency-wide, while a proposed HHS budget shows large cuts for the National Institutes of Health.

By MedTech Dive Staff • Updated June 6, 2025

Medtronic wins FDA approval for defibrillation lead

Omniasecure, which was authorized for placement in the heart’s right ventricle, is the world’s smallest defibrillation lead, according to Medtronic.

By Nick Paul Taylor • Updated May 5, 2025

ICU Medical receives FDA warning letter over infusion pumps

Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.

By Nick Paul Taylor • April 29, 2025

Medtronic submits Hugo soft tissue robot for FDA approval

William Blair analyst Brandon Vazquez said 2025 could be the first year market leader Intuitive Surgical will face meaningful U.S. competition.

By Susan Kelly • April 28, 2025

Medtronic seeks FDA nod for insulin pump, furthering Abbott collab

Receiving FDA clearance would allow Medtronic to pair its pumps with a glucose monitor being developed for the company by Abbott.

By Elise Reuter • April 24, 2025

Device developers advance AI plans despite Trump uncertainty

Trump administration policies have raised questions about how the FDA will regulate AI in medical devices. AdvaMed board members think the agency should keep its leading role.

By Elise Reuter • April 24, 2025

FDA issues early alert for BD catheters due to leaks

BD recalled certain intravascular catheters tied to reports of 10 serious injuries after finding an increase in cracks from “material fatigue.”

By Susan Kelly • April 21, 2025