FDA Clears CASMED’s FORE-SIGHT Tissue Oximetry OEM Module

CAS Medical Systems (NASDAQ:CASM) a leader in medical products for non-invasive patient monitoring of tissue oxygenation, announces receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its FORE-SIGHT® Tissue Oximetry OEM Module, an original equipment manufacturer (OEM) version of its next-generation FORE-SIGHT ELITE® Tissue Oximeter.

As quoted in the press release:

The OEM Module permits the highly accurate tissue oximetry values derived by CASMED’s FORE-SIGHT technology to be displayed on a monitor manufactured by a third party, rather than requiring a standalone FORE-SIGHT monitor.  The OEM Module includes a cable incorporating FORE-SIGHT technology that is connected to FORE-SIGHT disposable sensors placed on the patient’s forehead. The OEM Module is designed to require minimal user-interface modifications for use with third-party monitors.  CASMED expects a filing with the FDA for 510(k) clearance on its first OEM Module combination product before the end of 2018.

“Receiving FDA clearance is a major milestone as it creates a pathway for filing our OEM Module in combination with third-party monitors, making our best-in-class FORE-SIGHT oximetry technology available to manufacturers of other monitoring equipment and their customers,” said Thomas M. Patton, President and Chief Executive Officer of CASMED.  “Our OEM Module can open new sales channels for our disposable FORE-SIGHT sensors by allowing us to leverage partner selling resources to more quickly gain market share and expand the market for our oximetry.  We are making progress with an initial partner on our first co-development project, with the goal of a filing for FDA clearance on our first combination product by year-end.

Click here to read the full press release.