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SaMD based cardiovascular diagnostic device (ppg and ecg wearables)

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Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The contract involves engaging an external contractor to collaborate on the development of benchmark reference datasets specifically designed for validating and supporting algorithm development related to a Software as a Medical Device (SaMD) focused on cardiovascular diagnostics. This SaMD utilizes photoplethysmography (PPG) and electrocardiogram (ECG) wearable technologies to monitor cardiovascular health. The project aims to ensure the accuracy and reliability of these diagnostic devices through comprehensive dataset creation. This opportunity, forecasted by the Food and Drug Administration (FDA), falls under the NAICS code 541714, which pertains to research and development in the physical, engineering, and life sciences. While specific location details for the contract performance and solicitation number are currently unspecified, the FDA will oversee the contract management, with designated points of contact available for inquiries. The initiative highlights the agency's commitment to advancing innovative medical device technologies through rigorous validation standards.

General Info

Contract for developing benchmark datasets to validate SaMD cardiovascular diagnostic algorithms using PPG and ECG.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)View NAICS

Place of Performance

US

Set-Aside

NONE

Documents

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No documents available

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Timeline

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration
Contacts2 people available
OfficeN/A
Organization / Agency
Food and Drug Administration → Food And Drug Administration
Office AddressN/A
Contacts
Cdrh Acquisition Liaison
To Be Determined To Be DeterminedContracting Officer

Full Description

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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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National Institutes Of Health Olao

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