A software system that helps clinicians start and adjust blood pressure medication has become the second product accepted into a federal pilot that allows certain digital health devices to reach Medicare patients before the FDA has authorized them for that use.
The agency's participant list now names two manufacturers. Cadence Solutions joins with HypertensionOS, which supports clinician-supervised, protocol-bound initiation and titration of antihypertensive medication when predefined eligibility criteria and deterministic safety checks are met. Dexcom, named first to the pilot, joins a glucose health program intended to help patients and clinicians monitor metabolic and nutritional status and to aid in screening for prediabetes and type 2 diabetes.
