For people with type 1 or type 2 diabetes and the companies developing technologies to help them, the International Conference on Advanced Technologies & Treatments for Diabetes delivered an abundance of good news. On the type 1 diabetes front, Insulet Corp.’s RADIANT study demonstrated massive improvement in time in range as well as lower glycemic levels for patients switching from multiple injections to the Omnipod 5 automated insulin delivery system.
Tandem Diabetes Care Inc. reported that its next-generation automated insulin delivery algorithm, Control-IQ+ technology (Control-IQ+), is cleared by the U.S. FDA for use by people with type 2 diabetes (T2D) ages 18 and older.
As pulsed field ablation transformed the electrophysiology market over the last year, Boston Scientific Corp. emerged as the biggest winner by far. In its fourth quarter earnings call on Wednesday, the company quantified just how successful its Farapulse PFA system has been.
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.
During the week of July 24, 2023, the FDA published several notifications of potentially elevated risks associated with medical devices, including a recall of a delivery sheath for the Amplatzer device by Abbott Laboratories. The agency also announced that Abiomed Inc. will provide a correction for the instructions for use (IFUs) for the Impella because of an issue seen when implanting the left ventricular assist device in patients with transcatheter aortic valve replacement (TAVR) devices.
