Dive Brief:
- The Food and Drug Administration has selected Cadence, a software company that makes an artificial intelligence-assisted tool for hypertension management, as the second company for its digital health pilot.
- The Technology-Enabled Meaningful Patient Outcomes, or TEMPO pilot, exempts certain digital health devices from FDA premarket authorization requirements while allowing companies to collect real-world data through a related Medicare program.
- Cadence, which announced the FDA’s selection last week, plans to report real-world data related to the safety, performance and patient outcomes associated with its device to help inform how clinical AI systems are built and regulated in the future.
Dive Insight:
Cadence makes prescription software called HypertensionOS that is intended to help clinicians supervise medication management for patients diagnosed with Stage 2 hypertension. Clinicians with prescription authority, such as physicians or advanced practice registered nurses, may use the software to carry out routine steps in medication initiation and titration.
The software stays within predefined eligibility criteria and safety checks, Cadence said. The software is not intended for use in people with heart failure, pregnancy, active cancer or end-stage renal disease on dialysis.
“The opportunity for clinical AI is to extend the judgment and reach of clinicians by safely carrying out routine care within the boundaries they define,” Cadence CEO Chris Altchek said in a statement. “Our selection for TEMPO gives us the opportunity to help establish the evidence, safeguards, and operating model needed to bring that vision to millions of people living with chronic disease.”
A retrospective analysis of the software in more than 23,000 people found that people had an average blood pressure reduction of 7/5 mm Hg after 30 weeks.
The FDA’s TEMPO pilot coordinates with another new program by the Centers for Medicare and Medicaid Services to support the use of digital technologies for managing chronic conditions. Healthcare providers participating in the CMS model can offer devices chosen for the TEMPO program to improve patient outcomes.
Last month, diabetes tech firm Dexcom was the first company selected for the TEMPO program. In total, the FDA plans to accept up to 10 manufacturers in each of the CMS’ four focus areas: early cardio-kidney-metabolic conditions, cardio-kidney-metabolic conditions, musculoskeletal conditions and behavioral health conditions.
