For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical ...

Following a greenlight from the US FDA, Philips has enrolled the first patient in a trial of its newest intravascular ...

J&J inherited the Javelin catheter as part of its $13.1bn acquisition of Shockwave Medical, which completed in June 2024.

The Invisalign® Palatal Expander, launching in the UAE markets today, November 4, 2024, offers a revolutionary approach to ...

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

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

Akura Medical, a Shifamed portfolio company focused on reshaping the landscape of venous thromboembolism (VTE) care, announced today the US Food and Drug Administration has approved its ...

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

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

Award-winning medical technology innovator, Quanta Dialysis Technologies®, has confirmed the US Food and Drug Administration (FDA) has given 510(k) clearance for the use of its Quanta Dialysis System ...

With a unique world-first ability to perform laser atherectomy and laser-based intravascular lithotripsy using a single device, Philips takes a major step forward in the treatment of peripheral artery ...

"FDA grants clearance for study of Envoy Medical’s cochlear implant" was originally created and published by Medical Device ...