Semler Scientific Plans To Seek New 510(K) Clearance From FDA For Expanded Use Of QuantaFlo Following Correspondence With FDA - Filing
Portfolio Pulse from Benzinga Newsdesk
Semler Scientific is planning to seek a new 510(k) clearance from the FDA for the expanded use of its QuantaFlo product. The new clearance would allow QuantaFlo to be marketed as an aid in diagnosing a broader range of cardiovascular diseases beyond its current use for peripheral artery disease (PAD). PAD diagnosis has historically accounted for over 99% of QuantaFlo's revenue. The company will continue to sell QuantaFlo for PAD diagnosis while awaiting FDA clearance for the expanded use.
January 22, 2024 | 9:17 pm
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POSITIVE IMPACT
Semler Scientific is seeking FDA 510(k) clearance to expand the use of QuantaFlo. This could potentially increase the product's market and revenue by allowing it to be used for diagnosing a wider range of cardiovascular diseases.
The news of Semler Scientific seeking FDA clearance for expanded use of QuantaFlo is directly related to the company and could have a positive impact on its stock price in the short term. If the FDA clearance is granted, it could lead to increased sales and revenue, as QuantaFlo would be applicable to a wider market. However, the impact is somewhat speculative until the FDA's decision is made, hence the confidence score is not at the maximum.
CONFIDENCE 75
IMPORTANCE 80
RELEVANCE 100