Aesculap Received FDA Breakthrough Device Designation for Its M.scio® System, a Non-invasive Pressure Measurement System

The M.scio® System has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The non-invasive telemetric pressure measurement system is designed to offer continuous, long-term monitoring of intracranial pressure (ICP) related to cerebrospinal fluid (CSF) for managing hydrocephalus, utilizing a permanent, fully implantable sensor.

This an important step forward towards identifying the need for equipping neurosurgeons with an innovative technology to improve care for hydrocephalus patients.

Hydrocephalus is a condition for the buildup of fluid in the brain that affects mostly babies, but it can also affect people at any age.

The M.scio System is designed for both surgical and medical treatments for enhancing patient management. The M.scio System is designed to provide an alternative treatment to the currently available ICP monitoring modalities.

This designation is an acknowledgement from the agency that the device has the potential to provide more effective treatment than existing options.

Source: https://www.prnewswire.com/news-releases/fda-grants-aesculap-breakthrough-device-designation-for-the-mscio-non-invasive-telemetric-pressure-measurement-system-302231633.html