News | June 19, 2007

SACS Receives FDA Clearance for Medical Signal Handling

June 20, 2007 — SACS Medical has been granted 510(k) clearance by the U.S. Food and Drug Administration for sales of its systems in the US.

"FDA clearance is a stamp of quality that will facilitate us in our current search for industrial partners for SACS Medical," says Stan Mikulowski, CEO, SACS Medical.

The clearance is for SACS Medical’s system for medical signal handling, which can handle EEG signals, among others. The system is used by specialist clinics to diagnose, monitor and treat patients spread over a large geographical area from one centralized location. 510(k) clearance is a prerequisite for sales of this category of medtech products in the US.

SACS Medical provides IT-solutions for signal handling in health care and medical research. The SACS concept covers all from flexible and user-friendly workstations to powerful server systems.

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