Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cleerly, Hologic, Hummingbird Diagnostics, Natera, Nucleix.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accuray, Aces Diagnostics, Aidoc, Aizip, Asahi Kasei, Celloscope, Cercare, Circle CVI, Converge Medical, Melling, Moleculight, Net Health, Onestep, Qure.ai, Protavio, Repado, Teal Health, Thermedical, Zimmer Biomet.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BD, Bluewind Medical, May Health, Medivis, MPM Medical, Roche, Zephyrus.
“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.
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