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AI Medical Technology trials Dermalyser for diagnosing malignant melanoma




At the beginning of Skin Cancer Awareness Month, Swedish Artificial Technology start-up AI Medical Technologies announces the start of a clinical trial at 30 Swedish primary care facilities with Dermalyser, a diagnostic decision support system empowered with advanced artificial intelligence (AI).

The study is a prospective, pivotal confirmatory multi-centre, non-interventional clinical investigation with the following aims:

  1. Evaluate the clinical safety, performance and benefit of Dermalyser in patients with cutaneous lesions  where malignant melanoma cannot be ruled out
  2. Examine the user-friendliness of the device itself
  3. Document health economics data
  4. Trial is expected to be concluded in Q4, 2022.

Dermalyser is a decision support tool for medical professionals, from general practitioners to consultants, to classify suspected skin cancers such as malignant melanoma.

The equipment consists of a mobile phone with an app on which a dermatoscope is mounted for taking pictures with the mobile phone camera.

After entering patient information, the user takes a picture of the patient’s skin lesion, and a melanoma risk rating is displayed onscreen within a few seconds. The diagnostic precision and speed of results are far higher than traditional or alternative methods.

“The artificial intelligence behind Dermalyser is based on analysing an unrivalled library of 100,000 skin lesion images with the confirmed diagnosis”, says Christoffer Ekström, CEO of AI Medical Technology.

“Our solution shows an outstanding performance of 95 per cent sensitivity and 78 per cent specificity – exceeding that of a trained dermatologist – and we now look forward to validating this with real-world data in our clinical study”.

The clinical study is a multi-centre, prospective clinical trial to assess the diagnostic performance of Dermalyser when identifying malignant melanomas in patients seeking primary care for melanoma-suspected cutaneous lesions.

Magnus Falk, specialist in general medicine and Principal Investigator, comments:

“Since this study intends to study clinical applicability and diagnostic reliability, it is important to reflect the reality of primary care.

“Therefore, we intend to include patients from health centres representing different demographics, size, staffing and geographical location across several Swedish regions.”

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