HONG KONG – Pentax Medical Co., of Tokyo, has gained CE marking for its artificial intelligence-based polyp detector Discovery. The detector assists endoscopists in finding potential polyps during a colorectal examination. The software has been trained using more than 120,000 files from about 300 clinical cases.
TORONTO – Montreal’s Dialogue Technologies Inc. has received class 1 CE marking for artificial intelligence (AI)-powered software that enables the company’s existing telehealth platform to reduce the time required to triage patients in emergencies. The new AI-driven Dialogue Intake software also has “human-in-the-loop” capability ensuring real-time medical intervention to verify the accuracy of information provided physicians during telehealth consultation.
HONG KONG – Dreamed Diabetes Ltd., of Petah Tikva, Israel, has received both FDA clearance and the CE mark for an insulin dosing decision support software based on artificial intelligence (AI).
Melbourne, Australia-based regenerative medicine company Avita Medical Ltd. has received good news from the FDA. The company, which also has a presence in Valencia, Calif., said the agency gave its thumbs up to an investigational device exemption application for a pivotal trial (NCT04091672) evaluating the safety and effectiveness of the Recell autologous cell harvesting device in combination with meshed autografting for the treatment of acute full-thickness skin defects, such as degloving, crush wounds, abrasions, lacerations and surgical wounds.
