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Regulator names 2 more innovative medical devices
  • By Shim Hyun-tai
  • Published 2020.08.28 18:03
  • Updated 2020.08.28 18:03
  • comments 0

The Ministry of Food and Drug Safety has designated clinical decision support software that helps diagnose Parkinson's disease and a frameless stereotaxic navigation system for assisting breast cancer surgery as innovative medical devices.

The latest move has increased the total number of innovative equipment to four, following the first two products designated on July 22.

The Ministry of Food and Drug Safety has chosen two more products with the latest technology as innovative medical devices, following two similar designations on July 22. (MFDS)

Innovative medical devices are products that have improved or expected to improve safety and effectiveness from the existing equipment or therapies by applying the latest techniques, including information and communication, bio, and nanotechnology.

The designated products enjoy some benefits, such as getting evaluation priority over other medical devices or receiving a rapid screening by separated developmental stages.

The medical imaging software that assists the diagnosis of Parkinson's disease is under development with artificial intelligence (AI) technology.

The software finds the abnormal signs at the damaged brain site with magnetic resonance imaging (MRI) and aids healthcare providers' diagnosis, unlike the existing methods using positron emission tomography (PET) or computer tomography (CT).

The frameless stereotaxic navigation system can help surgery by locating breast tumors with augmented reality.

It provides medical personnel with three-dimensional images reconstructed with augmented reality technology that combines breast CT and actual body images of breast cancer patients, allowing a more accurate guide for removing the tumors.

"We will continue to support the development and commercialization of medical devices with advanced technologies by designating products as innovative medical devices, and also try to help the public experience new treatment technologies more quickly," the ministry said.

shim531@docdocdoc.co.kr

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