BrightHeart secures CE mark for AI-powered prenatal ultrasound platform
June 25, 2026
This authorisation will expand the B-Right AI platform’s use to Europe, as BrightHeart continues to roll the technology out across the US.
This authorisation will expand the B-Right AI platform’s use to Europe, as BrightHeart continues to roll the technology out across the US.
Cyclana Bio, a biotechnology company pioneering tissue-level approaches to women’s health, has announced it has received Health Research Authority (HRA) and Research Ethics Committee (REC) approval for its 500-patient clinical observational study, PEMP (Predicting Endometriosis Mechanisms and Populations).
Spotlight Medical, a Paris-based oncology diagnostics company, has announced that myStage Dx has received CE marking under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746).
Draeger has received FDA 510(k) clearance to market the latest software update for its Evita V800 ventilator. The version 3.10 software release introduces additional features designed to enhance mechanical ventilation for patients with pulmonary conditions, including acute respiratory distress syndrome (ARDS).
The power-injectable implantable port system is designed to support long-term vascular access in adult and paediatric patients.
AorticLab announced today that its FLOWer device received CE mark approval for extended use in transcatheter cardiovascular procedures.
LEM Surgical announced today that the FDA granted a new 510(k) clearance for its Dynamis robotic surgical system.
Masimo, a Danaher (NYSE:DHR) company, today announced FDA clearance for an opioid-induced respiratory depression (OIRD) detection platform.
FiberSense has announced that its Continuous Glucose Monitoring (CGM) System has obtained CE marking under Regulation (EU) 2017/745 as a Class IIb medical device. The system is intended for continuous monitoring of blood sugar levels and glucose trends in adults with diabetes.
AngioDynamics (Nasdaq:ANGO) announced today that it received FDA investigational device exemption (IDE) to initiate the RELIEF study.