Innovative Health Receives 50th FDA Clearance to Reprocess Medical Devices [Yahoo! Finance]
Abbott Laboratories (ABT)
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Source: Yahoo! Finance
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. 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 cli
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ABT
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- 10/15/25 - In-Line
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- 1/5/26 - Form 4
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