DreaMed Advisor Pro

DEN170043

DreaMed Diabetes, Ltd. · granted 2018-06-12 · product code QCC · Clinical Chemistry

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.1)
“DreaMed Advisor Pro is a software device that is designed to provide insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 1 diabetes using an insulin pump and a continuous glucose monitoring (CGM) system.”
AlgorithmAlgorithmic software device
source quote (p.2)
“Algorithmic software device”
Adaptive (vs locked)No
source quote (p.9)
“Further, the device algorithm has designated limitations and parameters to changes which seem generally consistent with the scope of recommendations and diabetes management tips generated by the device and implementable in insulin pumps, and seem generally consistent with clinical decision making.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.9)
“There are risks relating to cybersecurity as well as risks relating to data corruption specific to use of this device. General and special controls are sufficient to mitigate against these risks.”

Validation studies (3)

Reader study (MRMC)

n=15 patients · 3 site(s)

endpoints: proposed recommended changes to insulin dosing including the basal rate, carbohydrate ratio, and correction factors; behavioral or lifestyle changes recommended

standards: ISO 14971 Medical devices - Application of Risk Management to Medical Devices., IEC 62366-1:2015 Medical Devices - Part 1: Application of Usability Engineering to Medical Devices, IEC62304:2006 Medical Device Software - Software Life Cycle Processes, ISO 15223-1 Medical Devices - Symbols To Be Used With Medical Device Labels, Labelling, And Information To Be Supplied - Part 1: General Requirements, ISO 14155 Clinical Investigation Of Medical Devices For Human Subjects - Good Clinical Practice

Retrospective clinical

n=13 patients · 1 site(s)

endpoints: percentage of CGM time within the sensor glucose range of 70-180 mg/dL; percentage of CGM readings below 70 mg/dL

standards: ISO 14971 Medical devices - Application of Risk Management to Medical Devices., IEC 62366-1:2015 Medical Devices - Part 1: Application of Usability Engineering to Medical Devices, IEC62304:2006 Medical Device Software - Software Life Cycle Processes, ISO 15223-1 Medical Devices - Symbols To Be Used With Medical Device Labels, Labelling, And Information To Be Supplied - Part 1: General Requirements, ISO 14155 Clinical Investigation Of Medical Devices For Human Subjects - Good Clinical Practice

Bench

n=63 other

endpoints: identify potential use errors involved with use of DreaMed Advisor Pro and their associated harms and severities

standards: ISO 14971 Medical devices - Application of Risk Management to Medical Devices., IEC 62366-1:2015 Medical Devices - Part 1: Application of Usability Engineering to Medical Devices, IEC62304:2006 Medical Device Software - Software Life Cycle Processes, ISO 15223-1 Medical Devices - Symbols To Be Used With Medical Device Labels, Labelling, And Information To Be Supplied - Part 1: General Requirements, ISO 14155 Clinical Investigation Of Medical Devices For Human Subjects - Good Clinical Practice

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision summary PDF.

Predicate network

Postmarket — what happened after clearance

Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to De Novo AI/ML devices in the Clinical Chemistry panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/DEN170043