Press release

LPIXEL Announces Approval and Launch of Japan’s First Deep Learning-Powered SaMD for Brain MRI, EIRL aneurysm

0
Sponsored by Businesswire

LPIXEL Inc., a leader in image analysis and processing in life science and medical research, announced today the approval of “EIRL aneurysm,” its image analysis software that uses deep learning to identify suspected aneurysms from brain MRI. EIRL aneurysm will be the first deep learning-powered software as a medical device (SaMD) for brain MRI to receive approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

The PMDA is the agency responsible for regulating and approving pharmaceuticals and medical devices in Japan. LPIXEL successfully secured approval on September 17, 2019, and will make EIRL aneurysm commercially available in Japan.

Major Features

  1. Image Interpretation Support

    EIRL aneurysm supports the interpretation process by identifying sac-like structures of aneurysms in brain MRI that are larger than 2 mm. The sensitivity of the doctor interpreting the images without the software was 68.2%. In comparison, the sensitivity with the assistance of the software was 77.2%, suggesting an improvement in diagnostic accuracy.
  2. Seamless Integration with PACS and Modalities

    With its compatibility with DICOM, which is the universal format for image storage and transfer, image data can be sent and received with the pre-existing PACS and modalities installed in the hospital system. This seamless workflow allows for the analysis results to be delivered straight to the radiologist’s workstation.

About EIRL

EIRL is the collective name given to LPIXEL’s AI medical image diagnostic support technology. LPIXEL aims to provide solutions that enable a faster and more accurate diagnosis by implementing its unique algorithms to analyze medical big data, such as brain MRI, chest X-rays, and colonoscopy.

About LPIXEL

LPIXEL is a leader in advanced image analysis and processing technology encompassing the life science field. Founded in March 2014, LPIXEL is dedicated to offering research facilities top-tier image analysis technologies and medical diagnosis technologies, both of which adopt advanced AI technology. The company is currently working in collaboration with the University of Tokyo Hospital, the National Cancer Center Japan and other research institutions to further the development of its AI-based medical diagnosis technology. For more information, please visit https://lpixel.net/en/