Tandem secures CE mark for AID systems in T2D and T1D with pregnancy
June 8, 2026
The regulatory clearance covers the t:slim X2 and Tandem Mobi insulin pumps with Control-IQ+ technology.
The regulatory clearance covers the t:slim X2 and Tandem Mobi insulin pumps with Control-IQ+ technology.
The automated system is now available in the US, offering faster bloodstream infection detection and higher vial-loading capacity for high-throughput microbiology laboratories.
The app-integrated tool automates left ventricular ejection fraction assessment, supporting real-time cardiac evaluation in primary care and emergency settings.
Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its Nellcor pulse oximetry system with the Nell-EQ intelligent processor.
Medtronic (NYSE:MDT) today announced the receipt of CE mark approval for its Stealth AXiS surgical system for ENT procedures.
GE HealthCare has received FDA 510(k) clearance for MIM Contour ProtégéAI+ 2.0, an AI-enabled auto-contouring software designed to assist radiation oncology care teams with treatment planning.
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.