Zuno Medical Receives FDA De Novo Clearance for Zuno Smart Containers

CAMPBELL, Calif., September 15, 2022 (Newswire.com) - Zuno Medical, an innovative technology company, announced that the U.S. Food and Drug Administration (FDA) granted de novo clearance for Zuno Smart Containers in the United States. The Zuno Smart Container is the first and only rigid container system designed with real-time electronic monitoring for reliable processing and instant sterile barrier verification. 

"Processing failure delays in the OR are costly - in both time and money," adds Allan McNichol, CEO of Zuno Medical. "The Zuno Smart Container is unlike anything available today and allows for advanced, objective verification of the sterile barrier. It creates a new level of trust and confidence between all departments." 

During the autoclave sterilization cycle, the Zuno Smart Container creates a verifiable vacuum seal. The container continues to maintain and monitor the seal during transport and storage, enabling objective verification that the container's sterile barrier has not been compromised. A 2-step verification system consisting of both a visual and a tactile check allows users to confirm the sterile barrier is intact at any time and most critically before a set arrives in the operating room. 

"Our number one goal is patient safety," states Dr. Michael Bahk, a renowned orthopedic surgeon specializing in minimally invasive arthroscopy and shoulder arthroplasty. "Torn blue wrapped sets and filter errors often go unnoticed, jeopardizing patient care. Instant sterile barrier verification, even when prepping for cases the night before, removes the guesswork and eliminates the headaches."

Zuno Smart Containers are compatible with pre-vacuum autoclaves in use at healthcare facilities today and have been validated for use in four-minute sterilization cycles with a 30-minute dry time. They can hold instruments containing lumens with an inner diameter of 1.2mm or larger and up to 500mm in length. 

Zuno Smart Containers are available as a subscription service, granting rapid response times and eliminating the hassle of container maintenance and part replacement. With included routine service by Zuno technicians, healthcare professionals are afforded the peace of mind that Zuno Smart Containers are operating correctly. To learn more about Zuno Smart Containers and to evaluate the system in your facility, visit www.zunomedical.com. 

ABOUT ZUNO MEDICAL

Zuno Medical is an innovative technology organization headquartered in Campbell, CA. Specializing in breakthrough technology, Zuno Medical's corporate mission is to improve patient outcomes by providing innovative solutions to advance healthcare. For more information, please visit: www.zunomedical.com. 

Cautionary Statement Regarding Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zuno Medical's expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see Zuno Medical's periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zuno Medical's filings with the SEC. Forward-looking statements speak only as of the date they are made, and Zuno Medical disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers of this news release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release.

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Source: Zuno Medical