Murray Hill, N.J.-based C.R. Bard Inc. agreed to pay roughly $17 million to settle allegations that it violated the Anti-Kickback Statute in connection with the use of a self-referral form for sales of the company’s intermittent catheter.

Researchers from Children’s Hospital Los Angeles and the University of Southern California filed for protection of a pacemaker with a unique shape and configuration which is low profile.

A pair of investor calls on Jan. 22 added clarity to the rapidly evolving cardiac ablation market with Abbott Laboratories and Johnson & Johnson providing updates on their pulsed field ablation programs. Both outlined challenges in the U.S. market that continue to place them at a disadvantage compared to current market leaders Boston Scientific Corp. and Medtronic plc, though bright spots also shone through.

The volume of U.S. FDA warning letters to device makers oscillated significantly in recent years, but the agency posted a handful of these letters to kick off the new year. Five letters were posted Jan. 14, and dated between Dec. 6 and Dec. 19, 2024, but otherwise seem to have little in common.

With key officials yet to be confirmed at the U.S. Department of Health and Human Services, the acting secretary imposed an immediate pause throughout the department on publicly issuing any document or communication without first getting it approved by a presidential appointee.

Beta Bionics Inc. kicked off the new year with plans for an initial public offering of 7.5 million shares “as soon as practicable.” Expected to be priced at $14 to $16 per share, the IPO would gross $105 million to $120 million for the insulin delivery device maker.

In a boon for companies developing brain-computer interface (BCI) technologies, researchers have used a BCI and artificial intelligence to restore touch sensations in a bionic arm.

The backlog of requests for Medicare national coverage analyses is a matter of record, but a new analysis highlights how deep that backlog runs. CMS declared it will review a petition from Impulse Dynamics to consider coverage of cardiac contractility modulation, responding to a request the company filed more than two and a half years ago.

Masimo Corp. selected Catherine (Katie) Szyman, an industry leader with deep med-tech roots, to guide the company as it seeks to rebuild its reputation and revenues following a gritty two-year battle for control. Current CEO Michelle Brennan will serve as chairman of the Masimo board. Brennan stepped up to lead Masimo after founder and former CEO Joe Kiani resigned following a shareholder vote that ousted him from his position of board chair as part of a protracted proxy battle between Kiani and Politan Capital Management LP.

Roche AG secured U.S. FDA 510(k) clearance for its cobas liat sexually transmitted infection (STI) multiplex assay panels. The tests, which also received a Clinical Laboratory Improvement Amendments waiver, will enable clinicians to detect several STIs including chlamydia, gonorrhea and Mycoplasma genitalium, in as little as 20 minutes.