Devices & Diagnostics

NeuroWave releases new version of brain-monitor device in Europe, Canada

Cleveland neurotechnology device company NeuroWave Systems is ramping up its global marketing efforts by releasing the next-generation version of its flagship anesthesia-monitoring device in Canada and Europe. The new model of the NeuroSENSE Monitor, which uses an algorithm to help doctors tailor the amount of anesthesia patients need by displaying and interpreting electroencephalogram (EEG) signals […]

Cleveland neurotechnology device company NeuroWave Systems is ramping up its global marketing efforts by releasing the next-generation version of its flagship anesthesia-monitoring device in Canada and Europe.

The new model of the NeuroSENSE Monitor, which uses an algorithm to help doctors tailor the amount of anesthesia patients need by displaying and interpreting electroencephalogram (EEG) signals from both sides of the front of the brain, is smaller and lighter than its predecessor, according to a press release from the company.

Its 10.4″ compact version also includes more advanced software capabilities for users to access recorded data, and uses an advanced algorithm to better detect signals in noisy recordings.

The device received the CE Mark in June of 2010 and received a license to be marketed in Canada last August. NeuroWave signed a deal with CareFusion (NYSE: CFN) to distribute the device in December.

“With this new generation of NeuroSENSE product, we plan to implement an aggressive market expansion together with our distribution partners,” said Tatjana Zikov, president and CEO of NeuroWave, in a press release.

The company is raising up to $5 million to fund new hires to support the distribution of NeuroSENSE and to work on gaining FDA approval of the device, Zikov said in July. Chairman Bob Schmidt said the company has also brought manufacturing of the device to Cleveland from overseas.

“We’ve made significant progress there, reducing the price of the device,” he said.

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The company already has FDA clearance on its basic device, the NeuroFAST Monitoring System. He said the challenge now is getting U.S. clearance for the NeuroSENSE and other algorithms the company has developed to detect seizures and control delivery of anesthesia and analgesia drugs using brainwaves.

The company was created in 2003 and spun out of its parent company, CleveMed, in 2008. Initially it relied on federal and state grants and contracts to develop NeuroSense and its other brain monitoring technologies.