Jarame prepares an FDA pathway: 100,000-person RWD and a separated digital therapeutic module

[Press Release · 2026-08-17]

Refine real-world data through the AI Digital Care Log. Separate one treatment module. Then pursue a U.S. device pathway.

Dream AI Lab’s developmental-disability platform Jarame is preparing for U.S. FDA medical-device review. The plan is not to file the whole platform at once, but to isolate clinically intended functions as an independent digital-therapeutic module and enter in stages.

Jarame says about 100,000 people of developmental-disability real-world data have accumulated through the AI Digital Care Log. It also says improvement signals in the 30–65% range were observed on some treatment or function measures, depending on cohort and measurement conditions.

These figures are company-stated. They are not FDA-recognized clinical effectiveness. For a submission, analyzable subjects must be re-defined by diagnosis confirmation, baseline, actual intervention exposure, follow-up, instruments, concomitant therapy, missingness, and comparators—not by total users.

Why event counts are not clinical N

Jarame says data-processing methods used at Noah AI Labs—on the order of about 3.6 million events in a month—were applied to the AI Digital Care Log. Collected events are de-duplicated and normalized into person-level longitudinal records. For FDA use, the company plans a regulatory lineage that can trace source events, origin, decision rules, algorithm version, and edit history—not only the cleaned count.

Even millions of events are not millions of independent clinical samples. Total events, unique persons, completed therapy sessions, completed assessments, and long-follow-up subjects must be counted separately. Volume is a start. Lineage, completeness, bias control, and causal analysis must be joined before data can become RWE FDA can use.

RWE can support device decisions—if relevant and reliable

FDA’s December 2025 final guidance on real-world evidence for medical devices states that RWD may inform regulatory decisions when it is sufficiently relevant and reliable. Jarame’s large RWD could later support trial design, external controls, subgroup analysis, long-term safety, and post-market performance—after those quality tests, not because the count is large. (U.S. Food and Drug Administration)

First device: a working-name single module

The intended file is expected to be separated as working-name Jarame Therapeutic-01. The first product would not cover all developmental disability. It would freeze one age band, diagnostic condition, treatment goal, and clinical endpoint. Candidates include social communication, functional requesting, challenging behavior, or daily-living function—whichever currently has the strongest completeness and clinical validity.

Center search, home-therapy matching, scheduling, guardian–therapist communication, and general education stay on the existing platform. Patient-specific content selection, difficulty, intervention order, and next-step proposals that directly affect clinical outcomes move into separate device software. The architecture of that split is explained in Jarame’s FDA separation strategy.

Q-Submission first, pathway later

Before a formal file, Jarame plans FDA Q-Submission to discuss intended use, patients, endpoints, how far existing RWE can go, and what additional trial is needed. If no suitable predicate is found, a De Novo path is more likely for a novel low-to-moderate-risk device, but the final path must be set after predicate search and FDA discussion. (U.S. Food and Drug Administration)

Preparation covers more than clinical effect: software lifecycle, risk management, verification and validation, usability, cybersecurity, change control, complaints, CAPA, and post-market surveillance. FDA’s QMSR, effective 2 February 2026, incorporates ISO 13485:2016 by reference, so a quality system must cover development and operations. (U.S. Food and Drug Administration)

A platform of modules, not one frozen app

The strategy is to keep the AI Digital Care Log as developmental-disability RWD/RWE infrastructure and add indication-specific therapeutic modules on top. If the first module is authorized, later modules could cover communication, behavior, daily living, and sleep, with long-term effect and safety checked from actual use after market.