LPIXEL successfully secured approval on September 17, 2019, and will make EIRL aneurysm commercially available in Japan
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.
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.
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.
Source: Company Press Release