MedTech News
.................... by Andrew Celentano

Amend Surgical Proudly Announces ISO 13485 Certification, Advancing Toward Launch of Amend Tissue Tape™
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.

Spine Innovation Announces FDA 510(k) Clearance for LOGIC™ Titanium Expandable Interbody System
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 earns expanded FDA labeling for inhaled insulin
MannKind (Nasdaq:MNKD) announced today that it received FDA approval for an update to the prescribing information for Afrezza inhaled insulin.

HighLife wins CE mark for TMVR system
HighLife announced today that it received CE mark approval for its transcatheter mitral valve replacement (TMVR) system.

Penumbra launches next-gen Lightning Flash 3.0 thrombectomy system
Penumbra (NYSE:PEN) announced today that it launched the Lightning Flash 3.0 computer-assisted vacuum thrombectomy (CAVT) system.

The pandemic’s hidden toll: Millions of chronic conditions left undiagnosed
When COVID hit, health care systems around the world were turned upside down. Hospitals cleared beds, routine appointments were canceled and people were told to stay at home unless it was urgent.

Single gene found to influence gut bacteria balance and IBD susceptibility
Two recent studies from the University of California, Riverside, published in the same issue of Gut Microbes highlight the role of a gene called PTPN2 in protecting the gut from harmful bacteria linked to inflammatory bowel disease (IBD).

Using lab-grown lung tumors as test subjects for tailored cancer therapies
Lung cancer varies widely from patient to patient, and that diversity makes it hard to find effective treatments. Researchers at the Berlin Institute of Health at Charité (BIH) have developed a method to evaluate multiple therapeutic approaches on patient-derived “tumoroids”—miniature tumors grown from tissue removed during surgery at Charité.