SaMD based cardiovascular diagnostic device (ppg and ecg wearables)

Past New Requirement Updated

Agency
Solicitation expected
Estimated value
$25,000 to $250,000
Set-aside
No set-aside

Forecast facts

Anticipated award
NAICS code
541714 Research and Development in Biotechnology (except Nanobiotechnology)
Points of contact

Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.

About this forecast

The Food and Drug Administration (FDA) is seeking an external contractor to develop benchmark reference datasets for validating and supporting algorithm development of Software as a Medical Device (SaMD) based cardiovascular diagnostic devices, specifically photoplethysmography (PPG) and electrocardiogram (ECG) wearables. This is a new requirement with no set-aside restriction, and the solicitation is forecasted to release on February 1, 2026, with an estimated award date of April 1, 2026.

The estimated award value ranges from $25,000 to $250,000, and the contract falls under NAICS code 541714 (Research and Development in Biotechnology). Interested contractors should contact the FDA's Center for Devices and Radiological Health (CDRH) Acquisitions team at cdrhacquisitions@fda.hhs.gov for additional information and to express interest in this opportunity.

Forecast text

We will use external contractor to work with us and develop benchmark reference datasets for validating (and algorithm development) for SaMD based cardiovascular diagnostic device (ppg and ecg wearables)

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