Zepto Life’s FungiFlex mould panel is designed to identify 14 clinically important mould species based on cell free fungal DNA detected in plasma.
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it received expanded CE mark for its automated insulin delivery (AID) systems.
HORW, Switzerland, June 4, 2026 /PRNewswire/ — CeQur®, the company dedicated to simplifying mealtime insulin delivery for people living with diabetes, today announced two recent FDA clearances for CeQur Simplicity™: extended wear of up to seven days and a new 1-unit (1U) device.
Irvine, CA-based OrthAlign has announced FDA 510(k) clearance for the Lantern ASC system, a handheld orthopedic navigation solution designed for ambulatory surgery centers. The system pairs a reusable navigation unit with a procedural Smart Pack Kit to deliver accurate, real-time navigation for total knee, partial knee, and gap balancing procedures in both primary and revision cases.
GE HealthCare (Nasdaq:GEHC) announced today that it received FDA 510(k) clearance for its MIM Contour ProtégéAI+ 2.0 software.
Brain Navi Biotechnology Achieves Key Regulatory Milestone Following Recognition at the 22nd National Innovation Award
MILFORD, Mass., June 3, 2026 /PRNewswire/ — Waters Corporation (NYSE: WAT) today announced that the BD BACTEC FXI Culture System has received U.S. Food and Drug Administration (FDA) 510(k) clearance.
Clarius Mobile Health announced FDA clearance for its Ejection Fraction AI, an intelligent cardiac assessment tool integrated directly into the Clarius ultrasound app.
Philips (NYSE:PHG) announced today that it received FDA clearance for its Elevate Plus advanced imaging and AI and automation capabilities.
Pulmera announced today that it received FDA 510(k) clearance for its CBeam 3D intraoperative imaging platform.