HighLife wins CE mark for TMVR system
January 26, 2026
HighLife announced today that it received CE mark approval for its transcatheter mitral valve replacement (TMVR) system.
HighLife announced today that it received CE mark approval for its transcatheter mitral valve replacement (TMVR) system.
First-of-its-kind, rotation-free single-shot PFA catheter supported by strong safety and efficacy data adds to the groundbreaking Affera family of technologies in Europe
The patent’s focus on a constant-slope transition ensures a gradual and predictable stiffness profile
BELLEVUE, Wash., Jan. 22, 2026 /PRNewswire/ — Woori IO, an OSR company developing next-generation noninvasive glucose monitoring technologies, today commented on the U.S. Food and Drug Administration’s recent clarification regarding non-medical-grade wearable devices, noting that the FDA’s position establishes a regulatory framework highly conducive to Woori IO’s commercialization strategy.
Bridge to Life has received FDA De Novo clearance for its VitaSmart hypothermic oxygenated perfusion (HOPE) system for liver transplantation.
SonoMotion has received FDA 510(k) clearance for its Break Wave lithotripsy device to treat kidney stones.
Intuitive Surgical (Nasdaq: ISRG)+
has received FDA clearance for “several cardiac procedures,” CEO Dave Rosa said today while announcing the surgical robotics company’s latest financial and operating results.
MFUSE is designed to support clinicians in managing external bleeding by forming a flexible hydrogel barrier when applied to the wound site
SurGenTec’s ION-C system is now indicated for the treatment of cervical pseudoarthrosis when implanted bilaterally within the facet joints.
The Xpert GI Panel identifies pathogens directly from stool specimens collected in Cary-Blair transport media.