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.

The Medicare coverage story of the Cardiomems device has a Homeric air about it, spanning nearly a decade starting with an adverse local coverage determination in 2016. Abbott Park, Ill.-based Abbott Laboratories finally brought the story full circle with a successful national coverage determination that gives the device nationwide coverage for Medicare patients without the need to wrangle with Medicare administrative contractors.

The sedate uptake of pulsed field ablation (PFA) in Europe failed to presage the enthusiasm that drove the technology’s extraordinarily rapid adoption in the U.S. in 2024. Used to treat atrial fibrillation, PFA received its first U.S. FDA approval in Dec. 2023. At the time, Clarivate estimated that PFA had 7% of the global cardiac ablation market. By year-end 2024, it had 20% and Boston Scientific Corp. projected that PFA would represent up to half of the market by the close of 2025.

Boston Scientific Corp. notched another win with the U.S. FDA approval of its spinal cord stimulator (SCS), Wavewriter, for treatment of non-surgical back pain just a week after receiving the agency’s nod for its Farapulse pulsed field ablation system. The new indication comes four months after expansion of approved uses for Wavewriter to include painful diabetic peripheral neuropathy.

Trinity Biotech plc. paid $12.5 million to acquire Waveform Technologies Inc.’s biosensor and continuous glucose monitoring (CGM) assets. It also formed a partnership with Bayer AG to launch a CGM biosensor in China and India. These moves are part of Trinity’s transformation strategy to become a leading player in wearable biosensor technology.

Dexcom Inc. achieved the first integrations of an automated insulin delivery system (AID) approved for use in the U.S. with its G7 continuous glucose monitoring (CGM) integrating with Tandem Diabetes Care Inc.’s T2:slim X2, announced on Dec. 6, and integration with the Ilet Bionic Pancreas made by Beta Bionics Inc. revealed on Dec. 7.

The recently concluded American Diabetes Association’s (ADA) 83rd Scientific Sessions continued to build powerful use cases for continuous glucose monitors in an ever-wider population and to highlight the value of automated insulin delivery (AID) systems that are getting ever-closer to duplicating the function of a natural pancreas. In addition to the news from Medtronic plc and Dexcom Inc. BioWorld covered earlier this week, Abbott Laboratories, Tandem Diabetes Care Inc. and Insulet Corp. also presented bright projections for future performance.

Conformal Medical Inc. plugged the gap in funding needed to complete enrollment in the pivotal CONFORM trial for its left atrial appendage occlusion (LAAO) technology with completion of an oversubscribed $35 million series D fundraising round. The Conformal left atrial appendage seal (CLAAS) system is designed to close off the left atrial appendage in individuals with non-valvular atrial fibrillation to cut the risk of stroke and avoid the use of anticoagulants.

Abbott Laboratories received U.S. FDA approval for an expanded indication for its spinal cord stimulator (SCS) devices to include treatment of chronic back pain for individuals who have not had or are ineligible for back surgery. The FDA based its decision on the positive results from the DISTINCT study which showed that 85.2% of patients implanted with the SCS devices achieved significant reduction in back pain compared to 7.1% of those who received conservative medical management.