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 • April 30, 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

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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

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

Precision Neuroscience receives FDA clearance for brain implant

The electrode array, which can be implanted for 30 days to map brain activity, is a component of Precision Neuroscience’s planned brain-computer interface system.

By Elise Reuter • April 21, 2025

Medtronic gets FDA approval to use Simplera Sync glucose sensor with insulin pumps

The updated device allows users to pair the sensor with Medtronic’s insulin pumps, and is expected to grow the company’s diabetes business.

By Elise Reuter • April 21, 2025

HHS layoffs may be illegal, legal experts say

The federal health department sidestepped normal procedures as it laid off 10,000 employees, according to sources. One union has already filed an internal complaint, while at least two law firms are exploring suits.

By Rebecca Pifer • April 21, 2025

Ceribell wins FDA nod for algorithm to detect pediatric seizures

The clearance adds another feature for Ceribell to leverage as it tries to persuade hospitals to switch from conventional EEG systems.

By Nick Paul Taylor • April 21, 2025

Makary seeks to limit industry’s role in FDA advisory panels

Commissioner Martin Makary said the agency would, whenever possible, restrict drug company employees from participating as industry representatives on advisory committees.

By Ned Pagliarulo • Updated April 18, 2025

FDA cuts outlined in draft HHS budget

The draft budget would slash FDA’s budget authority, if approved by Congress.

By Elise Reuter • April 18, 2025

Budget draft outlines Trump’s plan to slash federal health programs

An OMB document proposes to cut the HHS budget by roughly one-third as well as eliminate several divisions and programs.

By Sydney Halleman • April 17, 2025

US launches probe that could set stage for pharma tariffs

The Commerce Department has begun a so-called Section 232 investigation into the national security effects of the U.S. importing pharmaceuticals and their starting materials.

By Ned Pagliarulo • Updated April 14, 2025

A judge blocked the FDA’s plan to regulate LDTs. What now?

One attorney said the ruling “isn’t quite the stake in the heart.” The FDA is unlikely to challenge the court’s decision, but Congress could still take on the issue.

By Susan Kelly • April 16, 2025

Intuitive wins FDA clearance for single-port robotic surgery stapler

CFO Jamie Samath said in January that the stapler clearance would trigger the start of “broad commercial efforts” for the single-port system.

By Nick Paul Taylor • April 11, 2025

Dexcom nets FDA clearance for 15-day CGM

The longer wear time should improve Dexcom’s margins and help it compete with Abbott, RBC Capital Markets analyst Shagun Singh said.

By Elise Reuter • April 10, 2025

RFK Jr. won’t appear before Senate panel this week

HELP committee chair Bill Cassidy, R-La., had invited Kennedy to testify April 10 on the sweeping layoffs of federal health workers Kennedy ordered last month. A hearing could still take place later. 

By Ned Pagliarulo • April 8, 2025

HHS layoffs characterized by confusion, errors

The sweeping workforce reduction that began Tuesday was made worse by mistakes and poor communication, including directions for some CMS employees to contact a director who died last year.

By Rebecca Pifer • Updated April 2, 2025

HHS layoffs could imperil medical device cybersecurity, Democrats say

The FDA has 3,500 jobs on the chopping block, which could hinder cybersecurity oversight, Democrats said during a House subcommittee hearing.

By Emily Olsen • April 2, 2025

‘Just goodbyes and crying’: CDRH hit in HHS mass layoffs

Teams working on communications and policy were cut from the agency on Tuesday, according to multiple FDA workers interviewed by MedTech Dive.

By Elise Reuter • April 2, 2025

HHS begins layoffs in chaotic fashion

The Trump administration sent out the first round of reduction-in-force notices early Tuesday morning, telling employees the cuts are necessary to improve efficiency.

By Rebecca Pifer • April 1, 2025

Texas judge overturns FDA’s lab developed test regulation, siding with industry groups

The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS Secretary Robert F. Kennedy Jr.

By Susan Kelly • April 1, 2025

Peter Marks, FDA’s top vaccine official, resigns

In his resignation letter, Marks cited disagreement with HHS Secretary Robert F. Kennedy Jr., who he said pushed “misinformation and lies.”

By Ned Pagliarulo • March 31, 2025

FDA OKs first at-home test for 3 STIs

Visby Medical’s at-home diagnostic, which can be purchased without a prescription, tests for chlamydia, gonorrhea and trichomoniasis.

By Nick Paul Taylor • March 31, 2025