Semler Scientific to seek 510(k) clearance from FDA for broader Quantaflo label

In a regulatory filing yesterday, Semler Scientific disclosed that Semler will seek a new 510(k) clearance from the U.S. Food and Drug Administration for the expanded use of QuantaFlo following correspondence with the FDA. “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. 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 filing stated.