CMR Surgical secures $200M for US robot rollout

Launching Versius in the U.S. is a top priority for CMR, which claims the system is the second most adopted soft tissue robot globally.

By Susan Kelly • 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 April 1, according to multiple FDA workers interviewed by MedTech Dive.

By Elise Reuter • April 2, 2025

3 takeaways from ACC 2025

Medtronic, Abbott and Boston Scientific had updates on their devices used in heart valve disease treatment at the event.

By Susan Kelly • April 2, 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

Bausch + Lomb recalls Envista intraocular lenses over safety risks

J.P. Morgan analysts said it was too early to discuss the financial impact of the recall, but estimated that $70 million to $90 million of revenue could be at risk this year.

By Nick Paul Taylor • March 31, 2025

Tandem eyes Medicare coverage expansion for Type 2

CMO Jordan Pinsker said Tandem hopes to expand Medicare coverage of its automated insulin delivery systems using new data shared at ATTD.

By Elise Reuter • March 31, 2025

J&J launches energy generator compatible with Ottava robot

Johnson & Johnson said the Dualto energy system’s design allows for up to 46% less footprint than separate generators.

By Nick Paul Taylor • March 28, 2025

‘Everything is word of mouth’: HHS employees face uncertainty in looming Trump layoffs

Many HHS department heads and employees were unaware of plans to fire some 10,000 employees until they were announced Thursday, sources said.

By Sydney Halleman , Ned Pagliarulo , Rebecca Pifer • March 28, 2025

Abbott snags early CE mark for Volt PFA device

With PFA becoming physicians’ preferred ablation method for treating AFib, Abbott is pushing to catch up with rival systems already on the market.

By Susan Kelly • March 28, 2025

Newly public Beta Bionics reports sales surge; Dexcom hires CCO

Sales of Beta Bionics insulin pumps spiked 145% in the fourth quarter behind solid new patient starts. Elsewhere, former Masimo exec Jon Coleman joined Dexcom, and Sibionics’ CGM earned the CE mark.

By Nick Paul Taylor • March 28, 2025

Dexcom rejects claims of unauthorized device changes in FDA warning letter

A company spokesperson said Dexcom plans to resolve the agency's concerns but stated no design changes were made to its glucose sensors.

By Elise Reuter • March 27, 2025

HHS to cut 10,000 employees in major restructuring under RFK Jr.

Advamed CEO Scott Whitaker said Thursday that “any reduction in force should be accompanied by policy and regulatory improvements that encourage innovation in medtech.”

By Ned Pagliarulo , Rebecca Pifer , Ricky Zipp • Updated March 27, 2025

Solventum cuts 800 positions

CEO Bryan Hanson told investors last week that the restructuring plan would save Solventum $120 million annually.

By Ricky Zipp • March 26, 2025

Senate committee advances Dr. Oz to lead CMS

Democrats on the Senate Finance Committee criticized the physician and TV personality ahead of the vote Tuesday for avoiding questions about potential cuts to Medicaid.

By Emily Olsen • March 26, 2025

Dexcom’s FDA warning letter reveals unauthorized changes to sensors

Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, according to the warning letter.

By Elise Reuter • March 26, 2025

Dexcom COO on 15-day glucose sensor, Type 2 coverage

Jake Leach caught up with MedTech Dive during the ATTD conference to discuss new data on the company’s glucose monitors and an FDA warning letter.

By Elise Reuter • March 25, 2025

5 tips for building a predetermined change control plan

The new framework is intended to make postmarket changes easier for products. Experts recommend having a clear roadmap and contacting regulators early.

By Elise Reuter • March 25, 2025

Abbott gets FDA nod to begin IVL trial after rivals buy up competition

J&J acquired the IVL device maker Shockwave Medical last year for $13.1 billion, and Boston Scientific agreed to buy Bolt Medical in January for up to $664 million.

By Nick Paul Taylor • March 25, 2025

23andMe files for bankruptcy; CEO Anne Wojcicki resigns

The DNA-testing company plans to sell its assets after the board rejected an acquisition proposal from Wojcicki.

By Elise Reuter • March 24, 2025

Why HCA is ‘all in’ on surgical robotics

Thomas Payne, HCA Healthcare’s national medical director of robotics, explains how the largest U.S. health system is vetting a new crop of market entrants.

By Susan Kelly • March 24, 2025

J&J boosts planned US manufacturing investment to $55B

Following big announcements from Lilly and Merck, J&J is pledging $55 billion over the next four years to open new plants.

By Jonathan Gardner • March 21, 2025

Smiths Medical recalls port implants, warns on endotracheal tubes

The business, acquired by ICU Medical in 2022, has been dealing with a series of recalls and quality issues over the past several years.

By Susan Kelly • March 21, 2025

FDA posts early alert after Calyxo urinary stone device tied to death

The alert describes a problem that can lead to excessive pressure in the kidney during procedures to remove urinary stones.

By Nick Paul Taylor • March 21, 2025

Tariffs are paused for USMCA-compliant goods. How can companies qualify?

Businesses that previously found pursuing USMCA treatment cost-prohibitive are scrambling to determine if they meet the trade deal’s requirements.

By Philip Neuffer • March 20, 2025

Dexcom shares 15-day CGM data; Tandem posts Type 2 pivotal data

Medical device companies presented new data this week at the Advanced Technologies & Treatments for Diabetes conference.

By Elise Reuter • March 20, 2025