“If at first you don’t succeed, try, try again” seems to be the motto of U.S. lawmakers – at least when it comes to the bipartisan Biosecure Act. After missing a ride last year in the must-pass annual defense spending bill, a version of the bill that seeks to protect the genetic data of Americans while securing U.S. pharmaceutical supply chains made it into the 2026 National Defense Authorization Act, which is now just a Senate vote away from becoming law.

Nephrodite Inc.'s Holly, an implantable, continuous renal replacement system, received U.S. FDA breakthrough device designation as a novel and potentially life-changing treatment for end-stage kidney disease. The system is designed to enable continuous blood filtration and allow patients freedom to go about their days without frequent, hours-long visits to a dialysis clinic or being hooked up to a filtration system at home.

The U.S. FDA recently cleared two new medical devices to treat benign prostatic hyperplasia, offering men with enlarged prostates additional treatment options which are minimally invasive. The approvals include Proverum Medical Ltd.’s Provee System and Zenflow Inc.’s Zenflow Spring Implant and Delivery System, both are first-line interventional therapeutic options which offer relief to the millions of men living with the condition.

Sometimes the darkest products (names) bring a bright spot of news to their developers, as the U.S. FDA clearance for Galway, Ireland-based Medtronic plc's Onyx liquid embolic system demonstrates. Onyx gained the indication for embolization of the middle meningeal artery as an adjunct to surgery for the treatment of symptomatic subacute or chronic subdural hematoma based on the EMBOLISE trial results. The approval represents a significant advancement in treating this common neurosurgical condition.

Ebenbuild GmbH is hoping that its digital twin technology platform that combines AI and physics-based computational models tailored to individual patients will transform respiratory care. From drug development to optimizing mechanical ventilation in critical care, the company’s software-based solutions aim to reveal what is happening in the ‘black box’ of the lungs, helping clinicians to improve outcomes and reduce mortality.