AI Medical Service (AIM) has completed its first regulatory review and device registration in Singapore for its artificial intelligence (AI)-based endoscopic diagnostic support device.
The Health Sciences Authority (HSA) of Singapore conducted the review and registration for the device, Endoscopic image diagnosis support software – gastroAI-model G.
Related: Sparrow launches FDA-approved phone stethoscope device in the US
It is designed to differentiate gastric lesions during endoscopy, classifying them as either neoplastic or non-neoplastic.
Medical startup AIM has been collaborating with the National University Hospital of Singapore (NUH) on joint research into endoscopic AI.
This partnership has demonstrated that AI can enhance endoscopists’ diagnostic capabilities, potentially detecting gastric cancer at earlier stages.
The Endoscopic image diagnosis support software – gastroAI-model G system functions by analysing still images from endoscopic examinations and providing immediate feedback.
It is capable of assessing whether a lesion is likely neoplastic, such as “Adenoma or Adenocarcinoma”, likely non-neoplastic, or “Low Confidence” for being neoplastic.
Furthermore, the software displays the confidence level of the diagnosis based on visual similarity with historical data and marks the lesion’s location on the image.
AIM is planning to continue its joint research with NUH, further developing AI products and expanding their functions and target organs to meet the needs of patients and practitioners in Singapore.
The company is also seeking approval in other ASEAN countries, through “the ASEAN Medical Device Directive” to streamline the medical device registration process across the region.
In December 2023, AIM received manufacturing and marketing approval for the AI-based endoscopic diagnostic support device that operates within the stomach.
