
Siemens Healthineers wins FDA nod for heart-attack-predicting test
Siemens Healthineers says a new FDA clearance will advance the care of people at risk of heart attacks in the United States.

Siemens Healthineers says a new FDA clearance will advance the care of people at risk of heart attacks in the United States.

Boston Scientific (NYSE: BSX)+
announced today that it received FDA approval for its navigation-enabled Farawave Nav ablation catheter and clearance for new Faraview software.

Novocure announced on Tuesday that the FDA treated its Optune Lua wearable device for treating metastatic non-small cell lung cancer.

Momentis Surgical (formerly Memic) announced today that it received FDA 510(k) clearance for its Anovo robotic surgical platform.

CMR Surgical announced today that it received FDA de novo clearance to market its Versius surgical robot platform.

Medtronic (NYSE: MDT)+ announced today that the FDA approved an early feasibility study to evaluate its Affera system for treating VT.

Iota Biosciences, a subsidiary of Astellas Pharma, announced that it received FDA investigational device exemption (IDE) for its bladder implant.

AccurKardia announced that it received FDA breakthrough device designation for its aortic valve stenosis (AVS) ECG-based AI screening software.

Regenity Biosciences announced that it received FDA 510(k) clearance for its RejuvaKnee implant for soft tissue injuries of the meniscus.

Procept BioRobotics (Nasdaq:PRCT) announced today that the FDA approved an investigational device exemption (IDE) trial for its Aquablation therapy.