
Signum Surgical wins FDA de novo nod for bioabsorbable implant
Signum Surgical announced today that the FDA granted de novo clearance for its BioHealx implant for treating anal fistula.

Signum Surgical announced today that the FDA granted de novo clearance for its BioHealx implant for treating anal fistula.

This tiny, biocompatible sensor may overcome one of the biggest hurdles that prevent the devices from being completely implanted.

Researchers have developed a “blood vessel-on-a-chip” for heart disease with the potential to change the future of drug testing and development. The technology could also reduce our reliance on animal testing.

The minimally invasive, 3d-printable device offers safer application and removal, along with improved bioelectronic performance.

A new surgical procedure gives people more neural feedback from their residual limb. With it, seven patients walked more naturally and navigated obstacles.

Developed using Unity, the software allows viewing of advanced 3D reconstructions directly on a surgeon’s computer.

IceCure Medical (Nasdaq:ICCM) announced today that the FDA granted clearance for its next-generation single-probe cryoablation system

Each patch now replaces up to 12 mealtime injections, equaling more than 1,000 fewer injections annually, according to a news release.

A heart attack is a life-threatening condition, with patients remaining at risk of premature death long after the actual attack—50% to 60% of patients die subsequently as a result of sudden cardiac death, triggered by cardiac arrhythmia.

SILVER SPRING, Md., June 27, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test that can be used to bring diagnosis to appropriately certified point-of-care settings for individuals at risk for hepatitis C.