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

Benzinga · Jan 22 16:17

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

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