CleveMed gets Canadian, European clearance for range of devices

CLEVELAND, Ohio — Cleveland Medical Devices Inc. has received Canadian and European regulatory approval to begin selling an array of devices, including sleep-apnea and movement-disorder diagnostic tools.

The clearance designations are “a big deal” to the company, also known as CleveMed, because they could help it double sales in the next two years, said Chief Executive Bob Schmidt.

All told, 10 products received clearance in the two countries, Schmidt said. The products include a wireless monitor for use in sleep labs, an education software system that includes hardware to be used in acquiring biological data and a movement-disorder assessment device.

The company plans to begin European and Canadian sales soon. It’s already selling the devices in Asia and the Americas, Schmidt said. He declined to disclose sales figures for the company.

CleveMed has been awarded several federal grants in recent years, including $1.23 million last year to develop technology for use in deep brain stimulation procedures.