A neurotechnology company is planning a clinical study aimed at helping it enter the deep brain stimulation market for Parkinson’s disease patients. Cleveland-based Great Lakes NeuroTechnologies is aiming to help surgeons and neurologists fine-tune deep brain stimulation (DBS) systems after they’ve been implanted in Parkinson’s patients. DBS involves implanting an electrode in the brain to […]
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 […]
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 […]
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 […]
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.
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:
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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.
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.
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.
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.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
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.
Cleveland Medical Devices Inc. has been awarded $60,000 from the Cuyahoga County New Product Development and Entrepreneurship Loan Fund to step up commercialization of its SleepView device for sleep apnea screening at home. CleveMed has a lineup of wireless diagnostic sleep systems, including SleepView, which is the smallest and lightest home sleep monitor with an […]
Medical device startup NeuroWave Systems Inc. has received the CE marking for its NeuroSense anesthesia monitor, enabling the company to sell its first product in Europe. The Cleveland Heights, Ohio company has been developing its brain-monitoring device since 2003 when it licensed the technology from co-inventor and now NeuroWave president, Tatjana Zikov. “This is a […]
Delphinus Medical Technologies Inc. has received $8 million in funding commitments to further develop an ultrasonic breast cancer detection device that could become an alternative to mammograms. The funding means that Delphinus can finally begin the process of commercializing its SoftVue device, which has undergone about 10 years of research and development. Unlike mammography, which […]
Cleveland Medical Devices spin-off company NeuroWave Systems Inc. is poised to introduce its first commercial product — the NeuroSense Monitor — without taking a single investor dollar. NeuroSense is a monitor that measures, analyzes and tracks the brain function of sedated or anesthetized patients. So far, NeuroWave and its former parent CleveMed have used federal […]
