The Canary, a pre-market medical device, measures a breath biomarker that may be used to monitor infection status and provide a pre-symptomatic warning of a developing infection. The Canary monitor may also provide individualized treatment bio-feedback.
Isomark’s patented technology, maintained by Wisconsin Alumni Research Foundation (WARF), is being developed to monitor exhaled breath to detect infections caused by a metabolic change in the body from viral, bacterial, and fungal sources soon after onset. By providing a pre-symptomatic warning of a developing infection, the Canary could expedite the delivery of care while reducing unnecessary treatment and improving the predictive value of other diagnostics. The Canary could also be used as a tracker for a patient’s response to antimicrobial treatment.
A multi-center pilot study published in January 2019 demonstrated that the Canary predicts the presence of infection up to 48 hours before clinical confirmation. Furthermore, this same study showed that over half of the subjects being empirically treated for an infection did not actually develop an infection. The study suggests that the Canary may provide real value in infection diagnosis and treatment that could prompt earlier diagnosis and appropriate treatment while improving outcomes.
The Canary is currently in clinical trials before submission for FDA review. For Investigational Use Only. The performance characteristics of this product have not been established.
When patients cannot eat due to illness, surgery, or injury, they often receive nutrients via alternative methods. Estimating nutritional needs delivered via enteral or parenteral methods proves challenging, especially when patients have multiple morbidities, including obesity, large wounds, and decreased kidney and/or liver function.
The Canary Clinical Nutrition monitor is currently in proof-of-concept studies. Preliminary studies showed that the BDV is reflective of the amount of Parenteral Nutrition (PN) is given. By examining the changes in exhaled breath, the Canary may be helpful in determining whether the patient is receiving adequate nutrition, being underfed, or conversely, being overfed.
For Investigational Use Only. The performance characteristics of this product have not been established.
The Canary has the potential to augment clinical workflow, guiding the clinicians decision making process to potentially find an infection faster and/or find the right treatment faster.