Brian Bossetta

Anteris Technologies has developed a next generation transcatheter heart valve for women and other patients with small anatomies in need of valve replacement. The company's president and director spoke to Medtech Insight about the product's innovative design and unmet need it aims to address.

In two separate warning letters published last week, the US FDA cited a manufacturer and a developer for marketing CPAP breathing devices without the required authorization; in a third letter from the same day, the agency rebuked a company for improperly classifying medical devices as unregulated ph

The FDA is proposing a rule that would allow device manufacturers to replace paper instructions for use with electronic labels. The proposal — part of the federal 2026 Unified Agenda — targets an NPRM publication in November 2026 and is expected to reduce regulatory burden on the industry.

HHS has delayed finalization of its HIPAA cybersecurity rule to July 2027, more than a year past the original May 2026 target. The department is still reviewing nearly 5,000 public comments and is separately seeking input on AI adoption in clinical care.

The US FDA has approved a novel dual-energy catheter ablation platform that enables electrophysiologists to deliver both pulsed field and radiofrequency energy through a single catheter. The platform provides physicians with greater flexibility to tailor ablation strategies based on patient anatomy.

In two recent warning letters, the FDA cited a Michigan manufacturer for marketing disinfection devices without required premarket authorization and a Tennessee firm for promoting its eyelid cleaning device for unapproved uses and for significant quality system violations.

Kinomatic and Whoop have launched a 12-week pilot to test whether continuous wearable monitoring can improve post-op outcomes and reduce opioid use in knee and hip replacement patients across three California clinics.

In two separate warning letters, the FDA cited ZIIP for alleged marketing authorization, promotional claims, and quality system controls violations related to its facial devices, and Nihon Kohden Digital Health Solutions for modifications to its patient monitoring software.

A malfunction in certain ResMed ventilators may cause the devices to stop delivering therapy, according to the FDA, which says the issue has been linked to five serious injuries and no reported deaths. Patients should continue using their ventilator unless instructed otherwise by their clinicians.

The FDA reports 35 serious injuries associated with a recall of spinal anesthesia kits from B. Braun Medical. In a letter to customers, the company instructed users to remove affected kits from inventory and discontinue their use. The FDA has classified the recall as Class I, the most serious.