2024-02-29 21:52:00
© Reuters.
VALENCIA, California – AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), specializing in regenerative medicine and skin restoration, has recently submitted a response to the United States Food and Drug Administration (FDA) regarding additional information for your RECELL GO™ device.
This step marks the continuation of the FDA review process under the Breakthrough Devices Program, following a request for information in October 2023.
The company’s response includes data from internal testing, which is intended to support the RECELL GO™ premarket approval (PMA) supplement. With FDA review expected in the remaining 90 days, AVITA Medical anticipates approval by May 30, 2024.
CEO Jim Corbett expressed his confidence in RECELL GO™, highlighting its potential to reduce training burdens and facilitate broader adoption in various medical applications.
RECELL GO™ is an extension of AVITA Medical’s RECELL® system, which uses the patient’s own skin cells to promote the healing of burns and other skin defects. The technology has been approved by the FDA for specific treatments and has obtained international approvals for a broader range of applications.
The company’s optimistic outlook for RECELL GO™ is based on its potential to streamline the training process for medical professionals, which may lead to greater use and impact on patient care. AVITA Medical has a history of developing innovative wound management devices and views RECELL GO™ as a strategic addition to its product portfolio.
The information provided in this article is based on a press release from AVITA Medical, Inc. As the company awaits the FDA’s decision, the healthcare community and investors are closely monitoring the potential expansion of AVITA’s regenerative medicine offerings.
This article has been generated and translated with the support of AI and reviewed by an editor. For more information, see our T&Cs.
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