Profusa Lumee Oxygen gains pre-approval orders as EU MDR decision looms
Profusa secures Lumee Oxygen orders ahead of EU MDR clearance. Discover what this means for CLTI monitoring and 2026 commercialization.
Gore’s TIPS expansion device wins CE mark: Could 6–10 mm range reshape portal hypertension shunt strategies?
Gore’s VIATORR device earns CE mark for 6–10 mm range, enabling tailored TIPS procedures. Find out how this could reshape portal hypertension care.
Medtronic expands Affera platform with Sphere-360 catheter CE Mark and IDE trial kickoff
Medtronic’s Sphere-360 catheter earns CE Mark and begins U.S. IDE trial. Find out what this means for the future of pulsed field ablation.
May Health’s Anavi System CE Mark highlights a new middle ground in PCOS infertility treatment
May Health’s Anavi System wins CE Mark. Find out what this means for PCOS infertility care, clinical adoption, and regulatory pathways in Europe.
What Nitinotes’ EASE trial tells us about the future of bariatric endoscopy
Nitinotes Ltd. has begun patient enrollment in its pivotal U.S. Investigational Device Exemption study evaluating the EndoZip Automated Suturing System for endoscopic sleeve gastroplasty (ESG). The first procedure in the EASE Clinical Trial was completed at Lenox Hill Hospital | Northwell Health in New York, marking the U.S. debut of the device. This study pits […]