MedTech News
.................... by Andrew Celentano
Smart shoe insert could improve mobility for people with walking problems
Maintaining balance while walking may seem automatic—until suddenly it isn’t. Gait impairment, or difficulty with walking, is a major liability for stroke and Parkinson’s patients. Not only do gait issues slow a person down, but they are also one of the top causes of falls. And solutions are often limited to time-intensive and costly physical therapy.
Techsomed Secures FDA 510(k) Clearance for BioTraceIO360 Kidney Ablation Indication
The expanded clearance extends BioTraceIO360 beyond liver applications to kidney procedures, advancing Techsomed’s vision of a multi-organ, AI-driven image-guided therapy platform that standardises minimally invasive cancer care.
Picard Medical expands artificial heart IP with new U.S. patent
Picard Medical (NYSE:PMI) announced today that it expanded its IP portfolio with a new U.S. patent for its next-generation artificial heart.
Cionic wins FDA nod for next-gen neural sleeve for mobility
Cionic announced today that the FDA granted clearance for its second-generation product, the Neural Sleeve 2.
Virtuoso Surgical wins FDA breakthrough device designation for surgical robot
Virtuoso Surgical announced today that it received FDA breakthrough device designation for bladder lesion removal with its surgical robot.
Heartflow gets FDA nod for next-gen plaque analysis tech
Heartflow (Nasdaq:HTFL) announced that it received FDA 510(k) clearance for its next-generation Heartflow Plaque Analysis algorithm.
Shoulder Innovations Announces Full Commercial Launch of the InSet™ 70 Humeral Stem
GRAND RAPIDS, Mich., Sept. 22, 2025 /PRNewswire/ — Shoulder Innovations, Inc. (Shoulder Innovations, or the company) (NYSE: SI), a commercial-stage medical technology company exclusively focused on transforming the shoulder surgical care market, today announced the full commercial launch of the InSet™ 70 Humeral Stem (“InSet™ 70”).
QuidelOrtho Announces Availability of QUICKVUE™ Influenza + SARS Test for Professional Use
SAN DIEGO, Sept. 22, 2025 /PRNewswire/ — Building on its leadership in point-of-care diagnostic testing, QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a leading global provider of innovative in vitro diagnostic technologies, is expanding its QUICKVUE portfolio with the QUICKVUE Influenza + SARS Test, a CLIA-waived, 510(k)–cleared rapid, easy-to-use immunoassay designed for professional use in physician office laboratories, urgent care centers, emergency departments, pharmacies and decentralized hospital labs.