Ypsomed gets FDA nod for digital add-on for autoinjectors
September 4, 2025
Ypsomed announced that the FDA granted 510(k) clearance for SmartPilot, a digital connectivity add-on for its Ypsomate autoinjectors.
Ypsomed announced that the FDA granted 510(k) clearance for SmartPilot, a digital connectivity add-on for its Ypsomate autoinjectors.
Roche announced today that it received CE mark approval for its port delivery platform containing its Susvimo therapeutic.
Medtronic (NYSE: MDT)+
announced that it received regulatory approval in Japan for its Symplicity Spyral renal denervation (RDN) system.
GE HealthCare (Nasdaq: GEHC)+
announced that it received FDA 510(k) clearance for its Revolution Vibe CT imaging system.
Surgerii Robotics announced on LinkedIn today that its Shurui single-port surgical robot garnered CE mark approval in Europe.
The submission for CT:VQ was supported by a clinical validation package that spanned a variety of lung conditions.
Imperative Care announced today that the FDA granted 510(k) clearance for its Symphony thrombectomy system to treat pulmonary embolism (PE).
Medtronic (NYSE: MDT)+
today announced major regulatory milestones for its MiniMed 780G automated insulin delivery system.
Abbott (NYSE: ABT)+
announced today that it received CE mark for an expanded indication for its Navitor TAVI system.
Medtronic (NYSE: MDT)+
announced today that it received FDA approval for the expanded redo-TAVR indication of its Evolut system.