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

MRI antenna can boost image quality and shorten scan times—without changing existing machines
Magnetic resonance imaging (MRI) is one of medicine’s most powerful diagnostic tools. But certain tissues deep inside the body—including brain regions and delicate structures of the eye and orbit that are of particular relevance for ophthalmology—are difficult to image clearly. The problem is not the scanner itself, but the hardware that sends and receives radio signals.

Scientists develop first-of-its-kind antibody to block Epstein Barr virus
Fred Hutch Cancer Center scientists reached a crucial milestone in blocking Epstein Barr virus (EBV), a pathogen estimated to infect 95% of the global population that is linked to multiple types of cancer, neurodegenerative diseases and other chronic health conditions. Using mice with human antibody genes, the research team developed new genetically human monoclonal antibodies that prevent two key antigens on the surface of the virus from binding to and entering human immune cells.

Medtronic’s blood pressure device wins coverage nod in Japan
Medtronic is investing in the rollout of the Symplicity Spyral renal denervation procedure, including hiring for new market development roles, CEO Geoff Martha said on an earnings call.

Senseonics launches automated insulin dosing system with 1-year CGM
The company has integrated its Eversense 365 implant with Sequel Med Tech’s insulin delivery system to automate the management of Type 1 diabetes.

GE HealthCare wins FDA nod for next-gen Signa MRI tech
GE HealthCare (Nasdaq: GEHC)+ announced today that it received FDA clearance for a trio of new MRI offerings.

Breath Diagnostics, Inc. Receives FDA Breakthrough Device Designation for OneBreath™ Platform to Aid Pre-Operative Pneumonia Risk Assessment
LOUISVILLE, Ky., Feb. 19, 2026 /PRNewswire/ — Breath Diagnostics, Inc., a leader in breath-based molecular diagnostics powered by patented microreactor capture technology, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its OneBreath™ platform.

FDA Clears IST’s ONE TRAY® for 365 Day Storage, Expanding Sterilization Flexibility for Surgical Facilities
DAYTON, Ohio, Feb. 19, 2026 /PRNewswire/ — Innovative Sterilization Technologies (IST) announced today that the ONE TRAY® sterilization container has received a second clearance from the U.S. Food and Drug Administration (FDA), significantly expanding its use across hospital and surgical facility workflows.

Sibel Health Receives FDA Acceptance into Drug Development Tool Qualification Program for Innovative Cough Monitoring Sensor
CHICAGO, Feb. 19, 2026 /PRNewswire/ — Sibel Health, a leader in medical-grade wearable sensor technology, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s recent Letter of Intent (LOI) into the Clinical Outcome Assessment (COA) Qualification Program under the Drug Development Tool (DDT) framework. The acceptance marks a significant milestone in advancing objective cough frequency measurement for adult patients with chronic refractory cough (CRC) using a novel Cough Monitoring sensor, the Aria sensor.