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.
The clinical distance between those two is the story. MedicalDaily previously reported on the selection of the first participant, a program built around monitoring and guidance. The new entrant sits closer to the prescribing decision itself.
The Mechanism Is Enforcement Discretion, Not Approval
The pilot does not approve anything. Under the Technology-Enabled Meaningful Patient Outcomes pilot, the FDA agrees not to enforce certain requirements when a manufacturer's device is offered in connection with the Medicare payment model for chronic care known as the ACCESS model. Those requirements can include premarket authorization and investigational device exemption rules, and the agency says they may also include informed consent and institutional review board requirements, decided on a case-by-case basis.
The agency states directly on the participants' page that the effectiveness of the devices selected for the pilot, for the intended uses under which they are participating, has not yet been evaluated by the FDA. Manufacturers collect, monitor, and report real-world data instead, and the agency expects them to eventually file a marketing submission using it.
That inverts the usual order. Conventional device review asks for evidence of safety and effectiveness before patients are exposed. This pathway gathers evidence during exposure, under conditions the agency negotiates on a case-by-case basis.
Eligibility is narrower than the headline suggests, as set out in the pilot's own criteria. Manufacturers must be based in the United States, the device must not present a potential for serious risk to patient health, safety, or welfare, and it must target one of four clinical use areas: early cardio-kidney metabolic conditions, cardio-kidney metabolic conditions, musculoskeletal conditions limited to chronic musculoskeletal pain, and behavioral health limited to depression or anxiety. Devices cannot be marketed for the same intended use outside the payment model, and finished products, not concepts, are required. The agency expects to select up to about ten manufacturers in each area.
The Reason the Second Entry Raises Different Questions
A glucose program that surfaces patterns for a clinician to interpret and a system that supports medication titration are different propositions, even under the same framework.
Antihypertensive titration carries defined risks in both directions. Too aggressive, and a patient becomes hypotensive, which in older adults raises the risk of falls and syncope. Too cautious and blood pressure stays elevated. The described product is protocol-bound and requires a licensed healthcare professional with prescriptive authority, such as a physician or an advanced practice registered nurse, which is a meaningful safeguard. Its listed indication covers outpatient management of adults who have diagnosed Stage 2 hypertension at the time of initiation, and patients who improve to Stage 1 while being managed with it may continue.
The population involved deserves attention. The payment model serves Medicare beneficiaries with chronic conditions, meaning older adults who are more likely to be on several medications at once and more susceptible to blood pressure that drops too far. These are the patients for whom titration decisions are least forgiving, and they are the ones in the pilot.
None of this establishes that anything will go wrong. It establishes that the safety margin narrows as the pilot moves closer to prescribing, and that the agency's listed contraindications field for both participants currently reads "not applicable."
The Unresolved Questions Underneath the Design
The pilot rests on a premise that has not been demonstrated: that real-world data collected this way can substitute, at least in part, for the prospective studies that device review has historically required. The agency expects participants to maintain a compliant quality management system, register and list their devices, and submit a plan covering data collection, monitoring, analysis, and reporting. What it lacks is a track record showing that data gathered this way carries a marketing submission.
There is also a selection question that needs to be named. The agency says it considers whether there is a reasonable expectation that a device could provide patient benefit, alongside risk, data collection plans, and alignment with the payment model's measured outcomes. Those are reasonable criteria. They are also judgments made without the evidence base a premarket review would normally supply, which is the point of the pilot and simultaneously its central uncertainty.
Several things are simply unspecified. What happens to a device, or to patients using it, if the real-world data proves inconclusive? What the public transparency will be, beyond an interim reporting plan the agency describes as possibly every six months. How a patient would learn that the software involved in their care is part of a pilot rather than operating under clearance, particularly where consent and review board requirements may not be enforced.
The Practical Position for a Patient Right Now
For nearly everyone, nothing. These products are offered under a specific Medicare payment model, not sold to the public, and cannot be marketed for the same use outside that model.
For a Medicare beneficiary whose practice participates in that model, the useful questions are ordinary ones. Ask whether any software is involved in medication decisions, what the clinician's role is in reviewing its recommendations, and whether the product has FDA authorization for that use or is operating under the pilot. A patient may decline participation in a care model without losing access to standard care.
Nobody should change or stop a blood pressure medication based on anything read here. Blood pressure that drops too low produces dizziness, lightheadedness on standing, fainting or falls, and any of those warrant a call to the prescribing clinician.
The pilot was established through a formal notice with no application deadline, and the agency says it will update the participant list as more manufacturers are selected.
Key Questions Answered
What is the TEMPO pilot? A program under which the FDA agrees not to enforce certain requirements, including premarket authorization, for selected digital health devices offered within a Medicare chronic care payment model.
Who are the participants now? Two manufacturers. Dexcom with a glucose health program, and Cadence Solutions with HypertensionOS, a system supporting clinician-supervised blood pressure medication titration.
Has the FDA found these devices effective? No. The agency states that the effectiveness of pilot devices for the intended uses in which they are participating has not yet been evaluated.
Which conditions are eligible? Early cardio-renal metabolic conditions, cardio-renal metabolic conditions, chronic musculoskeletal pain, and depression or anxiety.
Can I buy these products? Not for these uses. Devices in the pilot cannot be marketed for the same intended use outside the Medicare payment model.
What should a patient in the model ask? Whether software is involved in medication decisions, what the clinician's role is in reviewing it, and whether the product is authorized or operating under the pilot.
What happens next? Manufacturers collect and report real-world data and are expected to eventually file a marketing submission. The agency will add participants to its published list as they are selected.
