FDA Approves First AI-Powered Device to Detect All 3 Common Skin Cancers

To aid medical professionals in the detection of common skin malignancies, the Food and Drug Administration (FDA) of the United States has given its approval to the first AI-powered handheld medical gadget.

Specifically, basal cell carcinoma, squamous cell carcinoma, and melanoma are the three most common types of skin cancer, and this technology intends to provide a more precise method of detecting all three of these malignancies.

Table of Contents

1 Real-Time, Non-Invasive Detector of Skin Cancers
2 FDA Study
3 Medical Milestone

Real-Time, Non-Invasive Detector of Skin Cancers

DermaSensor, the forward-thinking firm that is responsible for the gadget, have only lately revealed that their real-time, non-invasive skin cancer evaluation system has received permission from the FDA.

As a result of this significant achievement, 300,000 primary care physicians in the United States now have access to a tool that allows for quantitative, point-of-care testing for all forms of skin cancer. This will help improve the diagnosis of skin cancer in primary care settings and speed up patient access to treatment that is important.

The fact that it is anticipated that one in every five people in the United States will be diagnosed with a kind of skin cancer by the time they reach the age of 70 highlights the significance of this accomplishment.

In the United States, the treatment of skin cancer is expected to cost $8.1 billion annually, and there are around 5.5 million new instances of skin cancer each year. On the other hand, according to DermaSensor, early identification has the potential to cure 99 percent of skin cancers, including melanoma, which has the potential to be lethal.

With the artificial intelligence-powered spectroscopic technology offered by DermaSensor, medical professionals are expected to be able to examine suspected skin lesions for cancer in a noninvasive manner. It is anticipated that the wireless handheld device will provide an objective result by utilizing an algorithm that has been approved by the FDA.

FDA Study

The excellent performance of the device was highlighted by the findings of a study conducted by the FDA with over one thousand patients and directed by the Mayo Clinic across twenty-two research centers.

A negative result suggested a 97 percent possibility of the lesion being benign for all skin cancers, whereas a positive result indicated a sensitivity of 96 percent for all 224 skin cancers. The study demonstrated overall sensitivity of 96 percent.

The DermaSensor device was used in a companion clinical utility research that involved 108 physicians. The results showed that the device effectively reduced the number of missed cases of skin cancer by half, hence improving the accuracy and trust of physicians while evaluating malignant lesions.

Cody Simmons, co-founder and Chief Executive Officer of DermaSensor, made a statement regarding the revolutionary influence that artificial intelligence has had in the field of healthcare, particularly when it is combined with cutting-edge technology such as spectroscopy and genetic sequencing.

The first gadget to receive approval from the FDA, which provides primary care physicians with an automated tool for analyzing worrisome lesions, was something that Simmons acknowledged his satisfaction in.

Medical Milestone

The benefits of this breakthrough extend beyond primary care physicians and extend to dermatologists as well, which will lead to increased collaboration between the two kinds of medical professionals.

DermaSensor is positioned to improve collaboration between primary care and dermatology, thereby streamlining referrals that are prioritized and improving the amount of recommendations for patients who have skin cancer.

Dr. Maurice Ferre, co-founder and chairman of DermaSensor, stated that the accomplishment of this medical milestone is a monument to the twelve years and tens of millions of dollars that our firm has invested in research and development in order to bring this powerful technology to market.

Beginning with the very first FDA pre-submission meeting that took place in 2016, we are extremely grateful to the Food and Drug Administration (FDA) for their collaboration and dedication to this field. After beginning the enrollment of patients in our pivotal study with the FDA in the middle of the year 2020, we are now overjoyed to have received clearance for our FDA-Breakthrough Designated De Novo submission,” he expressed further.