DERM awarded Class III CE approval

DERM makes medical history as world’s first autonomous skin cancer detection system is approved for clinical decisions in Europe

The Class III CE marking under the European Medical Device Regulation (MDR) 2017/745 reflects the highest level of regulatory scrutiny and underlines DERM’s safety, accuracy and effectiveness in detecting cancer in patients without clinician review. al decisions on skin cancer without oversight marking a transformative era for global healthcare.

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Class IIa

Skin Analytics achieves Class IIa UKCA Mark for DERM. The UK’s first and only Class IIa certified AI dermatology device

Now a Class IIa medical device, DERM, uses machine learning algorithms to recognise the most common malignant, pre-malignant and benign skin lesions, including melanoma – the fifth most common cancer in the UK. Using a decade’s worth of research and development on skin lesions, it is designed to accelerate patient diagnosis and relieve pressure on the healthcare system. 

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Skin Analytics Awarded ISO 13485 Certification

Skin Analytics Awarded ISO 13485 Certification

ISO 13485:2016 is an internationally recognised quality standard for medical devices and is a pre-requisite for registration as a class II medical device under the MDR. This accreditation represents another important milestone for the company and our mission to help more people survive skin cancer. 

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AI Standards for Healthcare

AI Standards for Healthcare

The last thing we want to see is innovation being suppressed under volumes of red tape. At the same time, we’re trying to change healthcare, meaning that we’re dealing with people’s health and that’s not an area to “move fast and break things” for fairly obvious reasons.

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