US-based bioabsorbable scaffold company R3 Vascular has been granted investigational device exemption (IDE) approval by the ...

US-based bioabsorbable scaffold company, R3 Vascular, has been granted investigational device exemption (IDE) approval by the US Food and Drug Administration (FDA) to launch its ELITE-BTK pivotal ...

Royal Philips announced enrollment of the first patient in THOR, a United States investigational device exemption (IDE) clinica ...

R3 Vascular announced today that the FDA granted investigational device exemption (IDE) to evaluate its drug-eluting ...

The technology is integrated with company’s electroanatomical mapping system, which helps guide operators during AF ablation.

Envoy Medical (COCH) announces that its Investigational Device Exemption, IDE, application for its pivotal study of the Acclaim Fully Implanted ...

Akura Medical, a Shifamed portfolio company, announced today that the FDA granted its Katana system investigational device exemption (IDE).

The Acclaim® Fully ImplantedCochlear Implant is differentiated from existing cochlear implants and may offer new option for hearing loss patients ...

The result calls into question the prospects of FDA approval for the Acurate neo2 valve, which is already in use globally.

Envoy Medical (COCH) announces that its Investigational Device Exemption, IDE, application for its pivotal study of the Acclaim Fully Implanted Cochlear Implant has been approved by the U.S. Food ...

Results were presented at Transcatheter Cardiovascular Therapeutics (TCT) 2024 conference from the first completed pivotal ...