FDA approves AI-powered skin cancer-screening device that's just a teensy bit tricorder-ish
Testing for this can can involve taking a chunk out of your flesh, making this a case of AI tech being kinder to humans
The US Food and Drug Administration has approved a handheld AI-powered medical device that helps doctors diagnose skin cancer.
The tool was developed by medical tech manufacturer DermaSensor, looks like a smartphone, save for the pointed tip on its bottom edge that beams light at skin lesions and analyzes the reflected signal to diagnose them.
Cancerous skin cells reflect light differently to healthy cells. Software running on the device has been trained by an AI model to detect those differences. The machine therefore responds by recommending clinicians to either "investigate further," or "monitor" a patient, all within a few seconds. The device doesn't confirm whether patients have skin cancer: diagnosis is left to healthcare professionals.
DermaSensor’s kit has been trained to analyze different types of skin cancer, including melanomas, squamous cell carcinomas, and basal cell carcinomas. The biz believes that AI will help primary care physicians (PCPs) catch the diseases at an earlier stage, making treatment easier.
- Breast cancer screening AI app OK'd by watchdog
- AI laser probe for prostate cancer enters clinical trials
- FDA clears way for an AI stethoscope to detect heart disease
- Watchdog rubber-stamps cavity-detecting neural network for dentists
Officials at the FDA approved DermaSensor's software after analyzing the results of a study, led by the Mayo Clinic, that involved testing the device at 22 different clinics. The results showed that it had a sensitivity, or true positive rate, of 96 percent across 224 different skin cancer cases, and a specificity, or true negative rate, of 97 percent. In a separate study 108 physicians using the device found helped cut the rate of missed skin cancer cases in half, decreasing from 18 percent to nine percent.
Securing FDA approval means that the company can legally market and sell their device to doctors across the country. One out of five Americans will reportedly have suffered some type of skin cancer by the age of 70. Luckily, the disease can be curable if detected early.
"We are entering the golden age of predictive and generative artificial intelligence in healthcare, and these capabilities are being paired with novel types of technology, like spectroscopy and genetic sequencing, to optimize disease detection and care," Cody Simmons, co-founder and Chief Executive Officer of DermaSensor, said in a statement.
"Equipping PCPs, the most abundant clinicians in the country, to better evaluate the most common cancer in the country has been a major, long-standing unmet need in medicine," he added.
Last year an odd thing appeared on my right leg and my doctor was worried enough about it that he administered a local anesthetic and used a nasty tool called a “biopsy punch” to extract a little cylindrical chunk of flesh so it could be sent to a pathologist.
I didn’t have skin cancer!
But the wound needed a stitch and became a infected. I was on antibiotics for a fortnight and wasn’t allowed to cycle or swim. I now have a scar.
So bring on the DermaSensor – to avoid the unpleasantness I experienced, and perhaps also reduce the resources required for this sort of routine testing, plus the occasional complications it can create.
The device requires a subscription that costs $199 per month to treat up to five patients, or $399 per month to support unlimited users and scans. ®