AI Medical Technology Receives ISO 13485:2016 Certification
Clinical study in Swedish primary care facilities to validate Dermalyser AI-driven decision support tool for diagnosing malignant melanoma progressing well
Stockholm, Sweden, Nov 2, 2022. Swedish Artificial Technology start-up AI Medical Technology announces its quality management system is now ISO 13485:2016 certified by BSI under the certificate number MD762240. This indicates that AI Medical Technology’s quality management system conforms to the recognized international standard for the design, manufacture and distribution of medical devices. The certification also demonstrates that AI Medical Technologies’ quality management system is aligned with EU regulations which will support commercialisation of its Dermalyser AI-driven decision support tool when CE marking is achieved.
“We are delighted to reach this next stage in our journey to provide dermatologists and physician with an accurate and reliable decision support tool to ensure rapid and accurate melanoma diagnosis,” says AI Medical Technology’s CEO Christoffer Ekström. “Currently we are receiving extremely promising feedback from our ongoing multi-center, prospective, non-interventional study involving 37 Swedish primary care facilities. As well as evaluating the clinical performance and user friendliness of Dermalyser, this will significantly build our image library – with over 100,000 skin lesion images by far the biggest in the sector – our AI learns from. Our aim is to complete the trial by the end of the year.”
For more information, please contact:
Christoffer Ekström, CEO AI Medical Technology
Cell phone: +46721748339
About malignant melanoma
According to Cancer Today, the incidence of new cases of malignant melanoma in 2020 was over 320,000 worldwide, https://gco.iarc.fr/today/home and every 4 minutes, a person dies of skin cancer. With a growing trend, patient cases are expected to reach almost 500,000 by 2040. Statistics further show that as many as 99% of the cases are curable if they are diagnosed and treated early enough, thus underscoring the importance of continuous self-examination and visiting your doctor in the case of a suspected skin lesion. Hence, early and accurate diagnosis is vital for saving more lives.
About AI Medical Technology
AI Medical Technology is a company operating in the interdisciplinary fields of data science, software development, and medicine. The company is dedicated to developing AI-powered diagnostic solutions that enable frontline healthcare practitioners to make easier, faster and more reliable diagnoses for their patients. AI Medical Technology was founded by a diverse team of driven, passionate tech entrepreneurs, software developers and clinicians. Following the initial funding round in 2021, the team is now focused on bringing the first product, Dermalyser, a clinically validated decision support tool for the diagnosis of all skin cancers through clinical trials and to the market. https://aimedtech.org/.