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Semler Scientific Plans To Seek New 510(K) Clearance From FDA For Expanded Use Of QuantaFlo Following Correspondence With FDA - Filing

Author: Benzinga Newsdesk | January 22, 2024 05:17pm

Semler will continue to market and sell QuantaFlo® as an aid in the diagnosis of PAD, which is responsible for over 99% of its historical revenue to date. The roll-out of QuantaFlo® as aid in the diagnosis of other cardiovascular diseases is subject to FDA clearance of the new 510(k) clearance. The new 510(k) is intended to enable expanded labeling for QuantaFlo® as an aid in the diagnosis of other cardiovascular diseases in addition to peripheral artery disease, or PAD.

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