Excel-Tech gains FDA 510(k) clearance of EMU 40 epilepsy monitor

By Elaine Rigoli

Tampa, Fla., June 1 - Excel-Tech Ltd. said Thursday that the Food and Drug Administration has provided 510(k) clearance for the company's EMU 40 epilepsy monitor.

The EMU 40 epilepsy monitor acquires a patient's surface-recorded brain data simultaneously with cardiac, oxygen and other vital signs, according to a news release.

It is primarily used by neurology specialists for patient monitoring and diagnosis of epilepsy.

The wireless capabilities of the EMU 40 epilepsy monitor allows for continuous brain monitoring in various hospital settings including inpatient, intensive-care unit and operating-room environments, the release said.

The EMU 40 epilepsy monitor is intended to replace the Mobee 32 epilepsy monitor.

Excel-Tech said it has agreed with Masimo Corp. to integrate Masimo's Signal Extraction pulse oximetry technology into the EMU 40 epilepsy monitor to allow for critical measurements of oxygen levels in the patient's blood.

Based in Oakville, Ont., Excel-Tech develops medical devices used to monitor the central and peripheral nervous systems.

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