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

CMR Surgical gains FDA clearance for new robot
CMR gained FDA marketing authorization for its first-generation Versius robot in October 2024 through the de novo pathway. In April, the company said it raised more than $200 million to support the commercialization of Versius.

Blood test can detect single lung cancer calls using infrared technique
A UK research team has developed a pioneering blood test that could change the way lung cancer is detected and monitored.

New ALS diagnostic blood test boasts 97% accuracy
ALS is a debilitating paralytic disease characterized as the death of upper and lower motor neurons. Fortunately, ALS is relatively rare, with an incidence rate of 1.6 per 100,000 adults, resulting in about 30,000 cases in the United States at any one time.

AI that predicts sequences within antibodies could lead to new therapeutic treatments
A new artificial intelligence model could help design antibodies that better protect the body against viruses and disease. The AI model, known as ImmunoMatch, can predict and identify correct protein pairings within antibodies, potentially helping to strengthen the immune system. The research was conducted by a team from the University of Surrey and University College London and is published in Nature Methods.

Hamilton Launches GlucoSense, a First-of-Its-Kind, Real-Time, In Situ Glucose Sensor for Mammalian Cell Culture
BONADUZ, Switzerland, Dec. 16, 2025 /PRNewswire/ — Hamilton today announced the launch of GlucoSense, a breakthrough in bioprocess analytics that introduces the first reusable, in situ glucose sensor designed to deliver continuous, real-time measurements directly inside cell culture bioreactors.

Zephyrus Innovations™ announces US FDA 510(k) clearance for VaporShield™ CSTD
Zephyrus Innovations (Zephyrus), a privately-owned medical device company designing and manufacturing safety syringes and Closed System Transfer Devices (CSTDs), today announces that it has received product 510(k) Marketing Clearance from the US Food and Drug Administration (“FDA”) for its VaporShield ™ CSTD.

MPM Medical Expands U.S. Manufacturing Capabilities, Acquires FDA 510(k) for Surgical and Advanced Wound Care Collagen
New production capacity strengthens MPM Medical’s position as a leading U.S. manufacturer and follows the company’s recent launch of collagen at-home wound care kits

Net Health Expands Wound Intelligence with MolecuLight Integration
PITTSBURGH, Dec. 16, 2025 /PRNewswire/ — Net Health today announced the platform integration of MolecuLight with Tissue Analytics, its AI-powered mobile wound imaging and analytics solution.