However......
I didn't see anything on the website about whether this solution works for all skin types. Having worked extensively in this space (computer vision deep learning for histopathology, cytology and biology, not skin specific) there are always confounding factors and biases in these models when analysing samples from minority groups. How does this model deal with lighter or darker skin? What about age? Sex? Hairy or smooth? Was the training set varied enough to cover these scenarios? Maybe consumers don't care about this kind of information, but that's the first thing I went looking for (well, the second thing. The first thing I looked for was the model used; DINOv2 if I read correctly).
Buried in an FAQ it says, "Our clinical evidence package (Document ID: IVY-CLIN-001, March 2026) includes the full summary report, audit protocol, reviewer credentials, sampling methodology, and ICD-10 mapping. Available on request." I really think that's the kind of thing that should be available up front.
The website also says, "Built to international medical-device and information-security standards." Then there are little breakout boxes for ISO13485, ISO27001 and UKCA-Class 1. Are you truly an ISO13485 and ISO27001 certified company? Or just somewhat disingenuously implying that. If you are, then publish your audit certificates. (Tiny text says, "Standards listed refer to our implementation framework. Certifications are issued upon successful audit by relevant regulatory bodies.") Is your model a UKCA-Class 1 certified medical device? If so, why not IVDR and FDA 510k as well? I was pretty surprised to see the offering is from a UK/HK company, as the marketing is pretty squarely at a US audience in my view, including the pricing in dollars. What about HIPAA and how you handle PHI? No mention of SOC2, which is more widely recognised (asked for) in the US than ISO27001.
I appreciate you may have built a nice product, that works quite well in common use cases, but this is a tough and highly regulated space to play in. Good luck.
bellamoon544•1h ago