We Secured Breakthrough Device Designation from FDA on PEDRA Xauron Perfusion System
Alira Health Secures Breakthrough Device Designation from the FDA on the PEDRA Xauron Perfusion System.
BOSTON, USA – Alira Health, a leading international healthcare and life sciences advisory firm, is proud to announce the firm’s Regulatory Affairs practice has secured a Breakthrough Device Designation from the FDA for the real-time tissue perfusion system, PEDRA Xauron Perfusion System.
“I am very excited and thankful for the opportunity to support a Breakthrough Device Designation with the PEDRA Team. This breakthrough designation will further expedite the premarket approval for an innovative technology that stands to benefit millions of patients suffering from critical limb-threatening ischemia (CLTI),” said Mary McNamara-Cullinane, Senior Vice President, Regulatory Affairs, Alira Health.
PEDRA’s real-time perfusion system is a non-invasive tool used for the treatment of critical limb-threatening ischemia (CLTI), a severe form of peripheral arterial disease (PAD). PAD is defined as a heavy blockage in the arteries of the lower extremities, which reduces blood flow.
FDA’s Breakthrough Device Program creates a pathway for patients to have more timely access to innovative medical devices by expediting their development, assessment, and review while preserving the statutory standards for premarket approval.
About PEDRA Technology, Inc.
PEDRA Technology is a medical device company that focuses on the use of tissue perfusion monitoring in the field of peripheral artery disease (PAD) and critical limb ischemia (CLI). The PEDRA™ Xauron™ Perfusion System is not currently approved for sale in the U.S. Learn more at PEDRAtech.com.
To read the press release on PR Newswire, click here.