Regulatory status in the United States
DeepSensi Public Benefit Corporation develops two different kinds of software functions, and they are regulated differently.
Our diagnostic device configuration is artificial intelligence clinical decision support software intended to help licensed physicians evaluate adult patients with undifferentiated or complex presentations. We consider this configuration a medical device. On July 31, 2026, we submitted a Pre-Submission to the U.S. Food and Drug Administration asking for its feedback on the device's regulatory pathway and validation plan. On the same date, we requested Breakthrough Device designation for this configuration. That request is pending, and no designation has been granted. This configuration has not been cleared, approved, or otherwise authorized by FDA and is not commercially available.
The Company's platform and corporate brand is DeepSensi Cognitive Engine. The device configuration described above has a separate name, DeepSensi Cognitive Medical OS. It is not cleared, approved or otherwise authorized by FDA and is not commercially available. The two names refer to different things, and we use the device name only where we describe the device.
Precision Suite is a separate software function. It gives a licensed physician an organized analysis of a patient's existing written records, with the sources behind each item, for the physician to review independently. Results go to the physician. A patient receives only what the physician chooses to share. Precision Suite does not analyze medical images or signals, is not intended for time-critical or emergency decisions, and makes no diagnostic accuracy claims. We believe Precision Suite meets the criteria for non-device clinical decision support in section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act. FDA has not reviewed or confirmed it.
The DeepSensi Edge Node home station is a consumer product and is not a medical device. It does not include any clinical monitoring, detection, or alerting feature. Such features are in development, have not been authorized by FDA, and are not offered for sale.
Canada
Where we state at checkout that Precision Suite is available to residents of Canada, it is offered there, outside Quebec, on the basis of Health Canada's guidance on software as a medical device, under which software that meets all of the guidance's criteria is not regulated as a medical device. Health Canada has not reviewed this position. Results go only to a physician licensed in the patient's province or territory.
Performance results
The performance results that we report relate to the diagnostic device configuration. They are development-cohort results from an internal measurement that is not independent of the Company. They are not claims about Precision Suite or the Edge Node. Prospective validation has not been completed.
Outside the United States and Canada
The criteria of section 520(o)(1)(E) do not apply outside the United States. In the European Union and in other jurisdictions, software of this kind may be regulated as a medical device. Precision Suite is not offered where local law requires an authorization that we do not hold.
What this statement does not say
Nothing in this statement means that any DeepSensi product is FDA-cleared, FDA-approved, FDA-compliant, or exempt as determined by FDA or by Health Canada. We will update this statement if FDA or Health Canada provides feedback that changes it.
