FDA Grants Orchestra BioMed Additional Breakthrough Device Designation for AVIM Therapy

Therapy Food and Drug Administration (“FDA”) Breakthrough Device Designations span the broader population of patients with uncontrolled hypertension despite medication at increased cardiovascular risk ...
Regulatory Affairs Professionals Society

FDA, CMS propose new parallel review pathway for breakthrough devices

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel ...
Hosted on MSN

A breakthrough medical technology is nearing FDA review and a $5B market

There's a moment when a medical breakthrough stops being an idea and starts becoming a real solution. TriAgenics' Zero3 TBA treatment is approaching that moment. For decades, wisdom tooth removal has ...
Fierce Healthcare

CMS, FDA announce new program to speed up Medicare coverage of breakthrough medical devices

The Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced on Thursday ...
Hosted on MSN

Medtronic's Sphere-9 wins FDA breakthrough after VT trial success

Medtronic has received FDA breakthrough device designation for its Sphere-9 catheter after early trial results showed 65.5% of patients remained free from ventricular tachycardia recurrence at six ...
JD Supra

CMS and FDA Announce RAPID Coverage Pathway to Accelerate Medicare Coverage for Breakthrough Medical Devices

Faster Medicare Coverage. The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration ...