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FDA Approves AI-Powered Handheld Device That Can Detect Skin Cancer

Jan 17, 2024 - forbes.com
The FDA has approved a handheld device by DermaSensor that uses artificial intelligence to detect skin cancer non-invasively. The device, which can identify all three common types of skin cancer, uses an AI-powered algorithm to analyze spectral recordings of suspicious skin lesions and provide immediate results. The FDA has authorized marketing for the device but has stipulated that it should only be used on lesions already deemed suspicious and that it should not be the sole diagnostic criterion.

The device will be priced via a subscription model at $199 a month for five patients or $399 a month for unlimited use. A study found that the device had a sensitivity of 96% across all forms of skin cancer and different skin types. Another study showed that the device reduced the number of missed skin cancer diagnoses by half. The development of the DermaSensor device cost $25 million.

Key takeaways:

  • The FDA has approved DermaSensor’s handheld device that uses artificial intelligence to non-invasively detect skin cancer.
  • The device can detect all three common types of skin cancer and signals to physicians whether a suspicious lesion should be investigated further.
  • The FDA authorized marketing for the device last week, but is also requiring that DermaSensor conduct additional post-market clinical validation performance testing.
  • The device will be priced through a subscription model at $199 a month for five patients or $399 a month for unlimited use.
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