Device for skin cancer detection
The DermaSensor™ is a fast, point-and-click device developed by health technology company DermaSensor to allow general practitioners (GPs) to swiftly assess any lesions in patients for the risk of skin cancer.
The DermaSensor has been designed as an objective tool to help clinicians evaluate suspected lesions for the most prevalent types of skin cancer, including basal cell carcinoma, squamous cell carcinoma and melanoma, in a timely and efficient manner.
The device received CE marking in Europe and is registered and commercially available for sale in Australia and New Zealand. It received breakthrough device designation from the US Food and Drug Administration (FDA) in May 2021 and is currently awaiting approval in the US.
The DermaSensor device is a standalone handheld unit and base with a power socket, complemented by software, an operating manual and recyclable packaging.
Weighing 1.9kg, the device is installed with a standard 110v-250v/50-60Hz general power outlet (GPO). The battery lasts for a whole day in practice.
The handheld unit uses artificial intelligence (AI) and spectroscopy to rapidly assess skin lesions for potential cancer. The desktop base supports wireless charging, eliminating the need for any wall-mounted installation or hardware. Its small footprint and ergonomic design allow it to be set up quickly on a desk.
The device’s secure wireless connectivity enables easy data transfer between the device and the DermaSensor companion software.
The DermaSensor device ensures the early detection of skin cancer through non-invasive optical spectroscopy.
The tip of the handheld unit is non-invasively pressed on the lesion of concern, before light pulses of more than 40 distinct wavelengths are emitted from the tip. The device receives and analyses data from the cellular and sub-cellular structures of a lesion, using elastic scattering spectroscopy technology.
The unit captures five quick recordings through the scans, which are then analysed by a proprietary machine learning system, delivering an instant high-risk or low-risk result.
The entire process takes less than 30 seconds for a lesion. The precise optics in the tip can detect pathological abnormalities on skin lesions as small as 2.5mm in diameter. The user-friendly on-screen interface guides users through the assessment step-by-step.
A randomised, prospective clinical trial was conducted with 57 primary care physicians in the US to evaluate the DermaSensor device’s potential. In the trial, the physicians assessed more than 5,000 lesions in patients.
The study results showed that the DermaSensor output improved the physicians’ ability to diagnose skin cancer by 13% compared to the analysis with no device output.
According to the outcome of the study, the usage of DermaSensor enhances physicians’ skin cancer detection sensitivity from 81% to 94%, with no significant loss in specificity.
The DermaSensor device makes real-time spectroscopic measurements and may detect 93% of skin cancer while sparing up to 37% of unnecessary morbidity from benign excisions, with easy operation and painless patient experience.
The device lets clinicians make more confident clinical decisions, improves the standard skin examination process and enhances the reimbursement level. It maximises income by offering a value-based skin health service with out-of-pocket payments for patients.
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