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AI skin cancer tool receives ClassIIA status in UK first

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AI dermatology company Skin Analytics has received regulatory clearance in the UK for its DERM medical device.

The advancement to Class IIA status makes Skin Analytics the first and only AI-based dermatology technology to secure the certification in the UK.

The AI-powered device is designed to speed up patient diagnosis by identifying cases earlier.

Rapid diagnostics has been identified in the NHS Long Term Plan as the biggest factor in cancer survival rates, which aims to increase the proportion of cancers diagnosed at Stages 1 and 2 from half to three quarters by 2028.

James Hamlyn, Quality Assurance and Regulatory Director of Skin Analytics, said:

Skin cancer rates are doubling in the UK every 10-15 years and about 30 per cent of dermatology posts in the NHS are unfilled.

“Healthcare systems are not equipped to deal with the volume of patients they need to see, especially in the light of the backlog created by Covid. AI can bridge this gap.

“Achieving Class IIA UKCA certification is therefore a significant milestone for our field and is a tribute to our organisation’s rigorous quality and evidence standards.”

DERM uses machine learning to help dermatologists identify the most common malignant, pre-malignant and benign skin lesions, including melanoma.

The technology is already supporting clinicians at five NHS sites. To date, DERM has helped assess more than 23,000 NHS patients, found 1,473 skin cancers and avoided 4,713 dermatology appointments.

Tom Wilson, Interim Rapid Diagnostic Centre Programme Director, Mid and South Essex Joint Commissioning Team commented:

“Mid and South Essex Health & Care Partnership started deploying Skin Analytics as a two year initial pilot across its primary care providers.

“The Trust was looking for a tool that could support GPs with decision-making, specifically, whether to refer a patient to the urgent two week wait referral, meaning that healthy patients can be identified as early as possible, freeing up capacity to focus on urgent cases.

“The strength of Skin Analytics’ technology is its ease of use with most practices only needing minimal training and the speed with which a GP receives feedback from the AI powered system.

“We have been impressed with the support shown by the whole Skin Analytics team to deploy the service across a large number of providers, particularly in regards to the team’s rigorous safety and risk management.”

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