The principle new information here for me is greater clarity on average FDA timescales for a decision on Spectral AI’s DeepView system. Notably ‘Based on historical data, a De Novo submission has averaged anywhere from 307 to 394 calendar days for a review to be complete and a decision to be made.’ This gives an ‘average’ decision window of potentially May 3rd to July 10th.
While there are certainly known unknowns here, such as the commercial potential, as well as the capability to reduce the device‘s form factor for a handheld version (for battlefield applications for example) I remain invested in this company and currently intend to be patient in waiting for the outcome of the FDA decision.
Spectral AI: Zacks maintains $5 valuation and expects mid-2026 FDA decision
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