Business
Innovative Health Receives 50th FDA Clearance to Reprocess Medical Devices
Innovative Health, Inc. today announced that the company has received its 50th clearance from FDA to reprocess single-use medical devices used in electrophysiology and cardiology labs. This latest clearance is to reprocess the Agilis NxT Steerable Introducer, originally manufactured by Abbott, for two additional uses in the lab. Innovative Health is the only reprocessing company that is cleared to reprocess this market-leading introducer two (2) times.
About this update from Abbott Laboratories
[{"type":"text","content":"On average, the fastest-growing cardiology reprocessing company has received one FDA clearance every 10 weeks for the past 10 years. ","length":137,"tagName":"p","attribs":{}},{"type":"text","content":"SCOTTSDALE, Ariz., Jan. 13, 2026 /PRNewswire/ -- Innovative Health, Inc. today announced that the company has received its 50th clearance from FDA to reprocess single-use medical devices used in electrophysiology and cardiology labs. This latest clearance is to reprocess the Agilis NxT Steerable Introducer, originally manufactured by Abbott, for two additional uses in the lab. Innovative Health is the only reprocessing company that is cleared to reprocess this market-leading introducer two (2) times.","length":505,"tagName":"p"},{"type":"text","content":"An FDA clearance to reprocess a single-use device requires extensive reverse engineering, coding, cleaning research and validation, and development of testing and inspection procedures. A narrow focus on cardiology and electrophysiology device technology has been the key to Innovative Health's impressive speed in getting FDA clearances: This focus has allowed the company to develop deep competencies in the technological, clinical, and regulatory aspects of device reuse within these clinical areas.","length":506,"tagName":"p"},{"type":"text","content":"An increase in the number of times a device, such as the Agilis NxT Steerable Introducer, can be reused has a direct, positive financial impact in hospitals that utilize Innovative Health's reprocessing program. FDA-cleared reprocessed devices are safe to use, and Innovative Health provides only functional, high-quality reprocessed devices to its partner hospitals.","length":371,"tagName":"p"},{"type":"text","content":""Fifty clearances in 10 years is something to be proud of," said Innovative Health CEO Rick Ferreira. "A strong commitment to helping healthcare facilities drive down procedure costs, a positive, collaborative partnership with FDA, and our staff of experienced reprocessing professionals have made this possible. And this is also what will make more clearances in the future possible."","length":405,"tagName":"p"},{"type":"text","content":"This 50th FDA clearance comes at a time when Innovative Health is greatly expanding its customer base and implementing novel, sustainable reprocessing t...