ALACHUA, Fla., Jan. 26, 2026 /PRNewswire/ — Amend Surgical, a medical device company focused on novel products for oral wound-care and regenerative biomaterials, today announced that it has achieved ISO 13485:2016 certification, the global standard for medical device quality management systems.
CORONADO, Calif., Jan. 26, 2026 /PRNewswire/ — Spine Innovation, LLC, a medical device startup that develops novel interbody fusion implants, announced today that is has received FDA 510(k) clearance to market the LOGIC™ Titanium Implant System.
MannKind (Nasdaq:MNKD) announced today that it received FDA approval for an update to the prescribing information for Afrezza inhaled insulin.
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.