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While the test offers information on whether or not certain treatments may be effective, the regulatory agency stressed that the results should never be used in care decisions.
Housed on a biochip, the startup's technology can deliver results from a single drop of blood within 15 minutes.
Suzanne Schwartz, Associate Director for Science and Strategic Partnerships at the FDA, shared insights and advice on medical device security, including cybersecurity attack response and best practices for CIOs and CTOs.
The definition is broad, but an accompanying whitepaper attempts to pin down the category's place in the industry.
Also: Funding announcements for Think Research, Kinetic and Aura.
The company said its new investment will fuel commercialization of its Pivot program, which consists of an app, a connected carbon monoxide breathalyzer and other resources.
CEO Robbie Cape said the investment will be used to meet demand, build new capabilities and ensure high-quality care.
The collective entity offers its vertically-integrated service to patients in Northern California, and is eyeing platform partnerships elsewhere in the country.
The latest version will be able to track brain signals, heart beat and breathing patterns.
The company plans to use the new money to help speed up its growth and development.