Seluna Ltd. launched a clinical study to validate its sleep diagnostic software, designed to support doctors to rapidly diagnose childhood sleep disorders and prioritize treatment for those who urgently need it. The study follows Seluna’s recent securing of nearly £650,000 (US$875,000) in funding.

A district judge has issue an Aug. 27 ruling enjoining Biosense Webster Inc. from tying its support for cardiac mapping equipment to purchases of the company’s catheters used in these procedures. According to the Association of Medical Device Reprocessors, the ruling triples previously announced damages, which will now cost Biosense nearly $450 million for violations of state and federal antitrust law.

Medtronic plc received U.S. FDA approval for the expanded redo TAVR indication of the Evolut transcatheter aortic valve replacement system. The approval allows for valve-in-valve implantation of a new Evolut valve inside a failed previously implanted TAV made by any manufacturer in patients with severe aortic stenosis considered high-risk for open-heart surgery.

The 50 million Europeans with peripheral artery disease have a new treatment option thanks to help restore blood flow to vessels below the knee now that Abbott Laboratories' Esprit BTK everolimus-eluting resorbable scaffold system has received CE mark. The stent, made of a material similar to dissolvable sutures, dissolves within three years.

A new entry in the peer-reviewed literature on Boston Scientific’s Agent drug-coated balloon seems to call into question whether in-stent restenosis should be treated with another stent, a discussion that could torque practice away from the stent-in-stent approach and toward the use of drug-coated balloons.

The U.S. FDA has cleared Artrya Ltd.’s 510(k) for its Salix coronary plaque (SCP) module that is a bolt-on module to the company’s Salix coronary anatomy platform.

The U.K. National Institute for Health and Care Excellence has recommended that physicians in the U.K. use the least expensive, clinically appropriate TAVR device when possible, concluding a pricing review that commenced roughly a year ago.

Medtronic plc posted nearly 50% year-over-year growth in its cardiac ablation business this quarter, with a 72% increase in revenue in the U.S., largely driven by pulsed field ablation. With significant opportunity in renal denervation and a new committee to look at growth including M&A and divestitures and another to review operations, analysts think the company stands a good chance of shedding its “chronic underperformer” image.

Onward Medical NV secured U.S. FDA investigational device exemption (IDE) approval for a pivotal study to assess the safety and efficacy of its implantable spinal stimulation technology, the ARC-IM system. The Empower study BP study will focus on addressing blood pressure instability in patients with spinal cord injury (SCI).

Some Apple Watch users will be able to monitor their blood oxygen levels through their iPhone, thanks to a software update the company planned to issue Aug. 14. The Cupertino, Calif.-based company pulled the feature from its watches in the U.S. in 2024, following a patent dispute with Masimo Corp., of Irvine, Calif., that threatened an import ban.