Pneumeric™ Inc., Medical Device Manufacturer of the Capnospot™, Receives FDA 510(k) Clearance with Superiority Claim

 // News

March 28  

Rochester, Minn. March 28, 2023 – Pneumeric™ Inc., developers of the Capnospot™, a disposable medical device that allows visual detection of gases during decompression by detecting carbon dioxide. Yesterday Pneumeric™ Inc. achieved an important milestone with the U.S. Food and Drug Administration.  The FDA issued Pneumeric a 510(k) clearance for the Capnospot™ device with a superiority claim to the current standard of care.  The issuance of the superiority claim validates Pneumeric’s position that the objective, visual detection provided by the Capnospot™ device is truly superior to the current standard of care.  Both the issuance and claim position Pneumeric™ to begin improving trauma patient care.

Pneumeric will be entering into the commercialization phase very soon.  Users and distributors have expressed excitement at the opportunity to partner with Pneumeric™ as the Company enters the market.

Traumatic chest injuries can cause a tension pneumothorax, occurring when pressurized gas builds up in the pleural cavity. During traumatic air leaks, death may result due to a gas buildup decreasing the cardiac system’s ability to sustain life. By performing a needle thoracostomy procedure, tension pneumothoraxes can be rapidly decompressed to restore cardiac filling and pressure equilibration. While the technique appears simple, it remains difficult for field providers to confirm therapeutic decompression rapidly and accurately. The Pneumeric Capnospot™, a disposable medical device that allows visual detection of CO2 gases during decompression, provides a real-time confirmatory color change that allows providers confirmation of accurate needle placement.

“Our simple yet innovative device is a significant improvement over the current method for needle thoracostomy,” says Dr. Johnathon Aho, M.D., Ph.D. “This simple, inexpensive device has clear applicability for first responders and trauma casualty caregivers, supplying rapid visual feedback confirmation that will ultimately save lives.”

For more information about Pneumeric™ Inc., please visit : Pneumeric™ Inc: Pneumeric™ Inc. is a leading medical device manufacturer that has developed the Capnospot™, a colorimetric capnography device with the potential to provide visual, objective, real-time feedback regarding needle placement during needle decompression

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