CleveMed licenses home sleep monitoring system to Midmark

Cleveland Medical Devices has signed a deal to license its home sleep monitoring technology to health equipment distributor Midmark.The SleepView monitor, which has already obtained regulatory clearance from the U.S. Food and Drug Administration, can help doctors conduct home sleep tests and make better treatment decisions for patients suffering from obstructive sleep apnea, according to [...]

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Parkinson’s disease monitoring firm gets $2M in NIH grants

Great Lakes NeuroTechnologies has received two federal grants totaling about $2 million to further develop its technologies for home-based monitoring of patients suffering from movement disorders, such as Parkinson’s disease.The largest of the two grants from the National Institutes of Health, $1.7 million, will go toward the development of a portable essential tremor monitor that [...]

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Parkinson’s disease monitoring is focus of Great Lakes NeuroTech

A Cleveland startup has developed a web-based system that assesses the severity of Parkinson’s disease symptoms and helps doctors better tailor medications to people with Parkinson’s.Great Lakes NeuroTechnologies has been around since 2006 as a division of Cleveland Medical Devices, but was spun off earlier this year as a stand-alone company to focus on movement [...]

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Meridian Bioscience gets FDA OK on pediatric C. difficile test

Diagnostics company Meridian Bioscience (NASDAQ: VIVO) has received federal regulatory clearance to begin selling a pediatric version of its C. difficile test. An earlier version of the test, which the company calls the “illumigene,” was cleared for commercialization by the FDA in July. However, that clearance didn’t apply to children.

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FDA 510(k) reaction: The entrepreneur

Bob Schmidt is a medical device entrepreneur who has started several companies, including Cleveland Medical Devices (CleveMed), Orbital Research, Neurowave Systems and Flocel. Schmidt said this about today’s proposed changes to the U.S. Food and Drug Administration’s 510(k) program:

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A look at Northeast Ohio’s growing neurotechnology industry

Cleveland Clinic neuromodulation spinoff Intelect Medical may have stealthily exited Cleveland to set up shop in Boston, but the company’s recent $78 million sale to Boston Scientific (NYSE: BSX) highlights Northeast Ohio’s growing strength in neurotechnology. Here’s a brief overview of the key players in Northeast Ohio’s rising neurotechnology industry.

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Neurowave strikes European distribution deal with CareFusion

Medical device startup NeuroWave Systems Inc. has reached a deal in which CareFusion (NYSE: CFN) will distribute NeuroWave’s brain-activity monitoring system in Germany and Scandinavia. It’s an important step for Cleveland Heights, Ohio-based NeuroWave, which in June received European regulatory clearance to begin selling its NeuroSense brain monitor for assessing anesthesia levels.

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NeuroWave Systems gets FDA clearance for brain-monitoring system

Medical device startup NeuroWave Systems Inc. has received regulatory clearance from the Food and Drug Administration to begin selling a brain-activity monitoring system. The Cleveland Heights, Ohio-based company’s NeuroFAST Monitoring System is intended for use in hospital operating rooms, emergency departments and intensive care units with patients who’ve experienced some sort of brain trauma, such as seizures.

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What can Kasich do to make Ohio’s medical industry happy?

When it comes to keeping smiles on the faces of Ohio’s medical industry leaders, Governor-elect John Kasich’s predecessor did him a big favor. It’s called Ohio Third Frontier.

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eHealth: a remedy for what ails doctors… and U.S. healthcare

Bob Schmidt thinks he has an answer for the mega trends of rising healthcare costs, fewer doctors to treat more patients, and provider pay-cuts by the federal government: eHealth. And for Schmidt’s Cleveland Medical Devices (CleveMed), eHealth means dreaming up diagnostic devices for sleep and movement disorders that can cut up to 90 percent of the cost of traditional tests — and even help primary care physicians find new revenue sources.

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