We Secured Breakthrough Device Designation from FDA on PEDRA Xauron Perfusion System

News
Category:
Published on:
February 2, 2021
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.

Related news

Events February 21, 2024
XXII Conferenza Nazionale Sulla Farmaceutica
Meet Giovanni Firenze, Partner Consulting Italy, onsite in Catania and learn more about the impact of the new AIFA reform.
Italy Regulatory
Events September 28, 2023
Regulatory Roundup
Look for our clinical development experts Chris Rao and Kenny Carberry as delegates onsite at MassMedic Regulatory Roundup.
MedTech Regulatory
Publications September 22, 2023
Impact of the New EU HTA Regulation on Access to Innovative Medicines in Europe
In this interview, Alira Health Partner Chus Castillo gives updates on HTA Regulation, related challenges, and potential effect on access to innovative medicines.
Biotech Healthcare Technology Regulatory Spain
Publications August 1, 2023
The EU Pharmaceutical Package: Impact on Orphan Medicinal Products
This article reviews the proposed changes in the EU Pharma Package for data protection related to orphan medicinal products (OMPs).
EU Pharma Regulatory
Publications July 10, 2023
The EU Pharmaceutical Package: Regulatory Protection Changes
Our regulatory experts present a more detailed analysis of the proposed changes introduced to Regulatory Data Protection (RDP).
EU Pharma Regulatory
Publications June 14, 2023
Medical Device Regulation: A Checklist for Preparation
This checklist can provide you with insight into where you stand in regards to MDR preparation and what you still need to address.
Medical Devices Regulatory
Publications May 25, 2023
The EU Pharmaceutical Package: Introduction to Changes
Alira Health’s Regulatory experts explore how the proposed package will disrupt the European regulatory landscape and what it means for companies.
EU Pharma Regulatory
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.