MedTech News

FDA clears EEG for brain analysis from Forest Devices
Forest Devices announced today that it received FDA 510(k) clearance for its SignalNED Model RE system for brain state analysis.

FDA approves expanded label for Boston Scientific Ingevity+ pacing leads
Boston Scientific (NYSE: BSX)+
announced today that it received FDA approval to expand the indication for its current-generation Ingevity+ pacing leads.

FDA approves enhanced Philips LumiGuide endovascular navigation wire
Philips (NYSE: PHG)+
announced today that it introduced the FDA-approved, 160 cm version of its LumiGuide endovascular navigation wire.

Edwards launches Sapien 3 valve with Alterra prestent in Europe
Edwards Lifesciences (NYSE: EW)+
announced that it launched its Sapien 3 transcatheter pulmonary valve implant (TPVI) system with Alterra adaptive prestent in Europe.

Medtronic unveils novel approach to studying adaptive deep brain stim for Parkinson’s
Medtronic (NYSE: MDT)+
today announced the publication of its novel approach to studying adaptive deep brain stimulation (aDBS).

Senseonics receives FDA clearance for one-year CGM
Commercial partner Ascensia is in discussions with insulin pump manufacturers to create an automated insulin delivery system.

Biotronik earns expanded FDA nod for pacing lead, delivery catheter system
Biotronik announced today that it received FDA approval for its Selectra 3D catheter and Solia S lead for use in left bundle branch area pacing (LBBAP).

Penumbra receives CE Mark for Lightning Flash 2.0 and Lightning Bolt 7
The company says that Lightning Flash 2.0 will be the most advanced thrombectomy system on the European market to address venous and pulmonary thrombus.