In a big step for healthcare tech, the U.S. Food and Drug Administration (FDA) has officially cleared a new handheld device that uses artificial intelligence (AI) to help doctors spot skin cancer. The gadget, developed by Miami-based company DermaSensor, could make early detection faster, easier, and more accurate.
How It Works
Imagine your doctor waving a small scanner over a mole or spot on your skin. That’s exactly what this device does. It takes special light readings from the skin and runs them through an AI algorithm. In just seconds, the device can tell if the spot might be cancerous and needs a closer look.
What makes this tool so useful is that it doesn’t require cutting into the skin or sending samples to a lab. It’s quick, painless, and non-invasive.
What Can It Detect?
The device can flag all three of the most common types of skin cancer:
- Basal cell carcinoma
- Squamous cell carcinoma
- Melanoma (the most dangerous form)
It’s not meant to replace a doctor’s full diagnosis, but it can act like an early warning system—giving doctors extra support when deciding whether to biopsy or refer a patient to a specialist.
What the FDA Says
The FDA gave the green light for the device to be used only on skin spots that a doctor already finds suspicious. So it’s not for everyday use on random moles, but rather as a second opinion tool during exams.
The FDA is also asking DermaSensor to do more testing after the launch to make sure the device works well across all skin tones and types.
How Much Does It Cost?
According to Reuters, doctors can get access to the device through a subscription plan:
- $199/month for up to 5 patients
- $399/month for unlimited use
This model allows clinics and practices to use the device regularly without paying a huge upfront fee.
Why This Matters
Until now, detecting skin cancer has mostly depended on a doctor’s eyes and experience. But a study last year showed DermaSensor could correctly detect skin cancer 96% of the time—across over 200 types of cancer and different skin tones.
In another study, it helped cut missed skin cancer cases in half. That’s a major improvement when you consider that early detection often makes all the difference in treatment success.
The Bigger Picture
AI is changing medicine fast. From Google working on medical chatbots to gene-editing breakthroughs, healthcare is entering a high-tech era. This new skin cancer scanner is just one more example of how smart tools can support doctors and help patients.
DermaSensor’s journey wasn’t cheap—research and development cost the company $25 million, according to their post on X (formerly Twitter). But with the FDA’s approval now in hand, this device could soon be in doctor’s offices across the country.
Source:
https://www.fda.gov/news-events/press-announcements/fda-roundup-january…
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-clea…
https://www.targetedonc.com/view/fda-approves-first-ai-powered-skin-can…
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