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.

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.

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.

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.

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.”

Updated March 27, 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.

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.

Solventum cuts 800 positions

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

Makary confirmed by Senate as FDA commissioner

The Johns Hopkins surgeon will helm the agency as layoffs loom and important decisions on treatments for rare and infectious diseases await.

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.

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.

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.

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.

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.

Academic medical centers say funding cuts jeopardize health research

Proposed cuts to National Institutes of Health funding threaten a critical pipeline of innovation and discovery necessary to fuel advancements in patient care, according to researchers and provider groups.

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.

Labcorp to close Los Angeles site, lay off 73 people

Labcorp lists the plant as part of its consumer genetics business and plans to begin eliminating positions in May.