Regulatory Approvals

Mawi DNA Technologies (Mawi), a leader in biosample collection technologies, announces the company received CE Mark and UK MHRA approval for its portfolio of...

Neural Sleeve™ First Algorithm-Powered Bionic Garment Designed to Help Those with Mobility Issues due to Multiple Sclerosis, Stroke, Cerebral Palsy, and Other Conditions, Regain...

Biobot Surgical has announced U.S. FDA 510(k) clearance of the iSR’obot Mona Lisa 2.0. The new robotic assisted transperineal needle-guidance system allows urologists to plan and...

GLEAMER, a French MedTech company pioneering the use of artificial intelligence technology in the practice of radiology, announced that the United States Food and...

SurGenTec®, a privately held spine and orthopedic technology company based in Boca Raton, FL, announced that it has received clearance from the U.S. Food...

System-Wide Ultrasound Platform, Blueprint, Works with Hospital and Health Systems’ Clinical and Administrative Infrastructures to Drive Point-of-Care Diagnostic Transformation Integration with Caption Health’s Platform Brings...

Masimo (NASDAQ: MASI) announced the FDA clearance of SedLine® brain function monitoring for pediatric patients (1-17 years of age) and the SedLine Pediatric EEG Sensor. With...

Viz.ai, the world leader in artificial intelligence (AI) powered care coordination, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for...

The RFID leader in medical devices expands its product offering by announcing FDA clearance for two new plating lines. Gramercy Extremity Orthopedics (GEO) announces FDA clearance...