Innovative Health Receives 50th FDA Clearance to Reprocess Medical Devices
On average, the fastest-growing cardiology reprocessing company has received one FDA clearance every 10 weeks for the past 10 years.
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.
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.
"Fifty clearances in 10 years is something to be proud of," said Innovative Health CEO
This 50th FDA clearance comes at a time when Innovative Health is greatly expanding its customer base and implementing novel, sustainable reprocessing technologies in its
About Innovative Health
Innovative Health is an advanced medical device reprocessing company that offers smarter utilization of medical devices in hospitals' cardiology and electrophysiology programs.
View original content:https://www.prnewswire.com/news-releases/innovative-health-receives-50th-fda-clearance-to-reprocess-medical-devices-302657587.html
SOURCE Innovative Health
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