(Alliance News) - Almawave Spa announced Monday that it has obtained "prestigious certifications related to the use of Artificial Intelligence" in healthcare, a sector "that requires strict adherence to authority standards."

Almawave, over the past two years, has worked to obtain two prestigious certifications in the healthcare field-issued by the DNV certifying body-synonymous with authority and quality of offerings, it noted in a note.

The first, in accordance with the international standard ISO 13485, certifies the company's management system related to the development of healthcare software to support clinical decision-making; the second, in accordance with the European Medical Device Regulation 2017/745, certifies compliance with regulatory requirements related to the design, manufacture and marketing of medical devices in the countries of the European Union. In 2021, the requirement for this type of certification was also extended to Artificial Intelligence-based applications.

"Almawave is therefore one of the first companies in Europe to have MDR certification that is issued by a Notified Body," the company comments.

This certificate is related to "DevAIce," a Medical Device solution based on an AI application, developed in-house by the Almawave team and successfully validated in an operational clinical trial. Specifically, this solution, linked to Covid pathology, enables the creation of an indicator for predictive risk stratification for use in telemedicine.

This, by facilitating the remote monitoring of patients and thus providing physicians with information on disease progress, allows for accurate analysis of the patient's condition and the processing of valuable information to support medical personnel.

"I am very happy that Almawave has achieved these important certifications. Artificial intelligence will certainly be able to support a path not only of efficiency of Healthcare, but also of improvement of people's quality of life," commented Valeria Sandei, Ad of Almawave.

"The important thing is that the adoption of potential new technologies in the telemedicine area is always accompanied by strict criteria aimed at protecting people. MDR certification, particularly on innovative topics such as those we deal with, is a long and complex path, but aimed at ascertaining technical and clinical aspects of primary importance," Sandei concluded.

Almawave trades up 1.5 percent at EUR4.12 per share.

By Chiara Bruschi, Alliance News reporter

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