RE:RE:RE:Stock movementA significant breakthrough in Skin Cancer detection…FDA approved
Prested, I read your post and Googled the latest skin cancer approval products, FDA, and this popped up;
Dermasensor:
https://readwrite.com/fda-approves-ai-powered-dermasensor-for-enhanced-skin-cancer-evaluation/ Further digging shows they invested 21 million dollars to get to this point, and they are trading at a ~$41 million valuation. Then I dug a little deeper and found this;
https://www.accessdata.fda.gov/cdrh_docs/pdf23/DEN230008.pdf It looks like they have a 3-year timeframe before they can sell their product commercially, unrestricted. They have a de novo (from the beginning) status, which comes with many restrictions, as detailed in the FDA filing above. MedX is cleared as a Class 2 medical device in 38 countries to be commercialized in the UK with Health Partners without any restrictions. MedX still has to prove itself and drive revenue, but it is quite apparent the medical device market is a long sales cycle. The devil is always in the details.