This is the moment Spectral AI's entire investment thesis has been built toward. Nearly eleven months after submission, the FDA has today granted De Novo classification for the DeepView® System for burn indications, authorising immediate commercial distribution across the United States in burn centres, trauma centres, and emergency departments. This is not a conditional approval or a limited clearance; it is full commercial authorisation, and it removes the single largest risk overhang on the st ....
