CleveMed Blogs

CLEVELAND, OHIO, October 27, 2009 – CleveMed recently had its Quality Management System certified to the requirements of ISO 13485:2003 and the Canadian Medical Device Conformity Assessment System by BSI, one of the world′s leading certification bodies. BSI also certified CleveMed to European Medical Device Directive 93/42/EEC which is required to place the CE mark on its products. These certifications allow CleveMed to distribute its products to the large European and the Canadian markets and strengthen its worldwide market presence.

CleveMed designs, manufactures, and sells a number of telemetry-based patient monitors for sleep disorders such as sleep apnea and movement disorders including Parkinson′s disease. Accuracy, portability and ease-of-use allow CleveMed′s products to be uniquely suited to speed diagnosis and improve disease management of these disorders in emerging US and international markets. These non-traditional, growing markets include the home, hospital rooms, private practices, and many others. As a leader in miniaturized wireless telemetry, physiological monitors CleveMed has been successfully commercializing a research andeducation product line that will benefit tremendously from international markets as well.

“CleveMed undertook the rigorous medical device certification as part of its commitment to developing products with the highest quality that fulfill un-met clinical needs for patients and providers” stated Hani Kayyali, President of CleveMed. “It is a testament to our continued growth and excellence in these important medical fields.”

Robert N. Schmidt, Chairman and CEO of CleveMed stated “This is an important milestone for the company. Opening up new markets for us in Europe and around the world will allow us to double our commercial sales over the next year or two.”

About CleveMed

CleveMed is pioneering the use of novel wireless monitoring systems for high growth neurology and rehabilitation applications. Through these innovations, CleveMed has developed a growing range of products that address the needs of the medical, research and academic communities around the world. Cleveland Medical Devices Inc.′s mission is to develop, manufacture and market rehabilitation and monitoring products that improve quality of life and allow patients to leave the hospital earlier, thus lowering total health care costs. For more information, please visit www.clevemed.com

For More Information Contact:

Amy Rickard
Cleveland Medical Devices Inc.
Phone: 216.791.6720
arickard@clevemed.com
www.clevemed.com

While most people know what tremor is when they see it, they may not realize that many different types of tremor exist and why it is important to recognize them. The current gold standard of visual assessment may be blind to subtle characteristics unique to different tremor types. Tremor is a common motor symptom associated with a number of neurological disorders. Defined as rhythmic, involuntary, to-and-fro movements of a body part, tremor is most common in the hands, but can occur in the arms, legs and head. Tremor can be an especially debilitating movement disorder symptom and make activities of daily living, such as dressing, eating and writing, difficult or sometimes impossible without the help of a family member of caretaker.

Several movement disorders produce tremor as a motor symptom. The two most common are essential tremor (ET) and Parkinson’s disease (PD). ET is a common disorder characterized by uncontrolled trembling of the hands and often involuntary nodding of the head. It is the most prevalent movement disorder, affecting nearly 10 million people in the United States alone. PD is a progressive disease associated with the destruction of brain cells that produce dopamine and characterized by muscular tremor, slowing of movement, partial facial paralysis and peculiarity of gait and posture. There are currently about 1 million people in the United States living with PD.

In addition to different disorders producing tremor, different tremor types may exist within a particular disorder, each with unique physical characteristics. Two of these important characteristics are amplitude and frequency. Amplitude refers to how big the movement is while frequency refers to the speed or rate at which the oscillation is happening. Rest tremor is one type that occurs when the affected limb is completely at rest. Resting tremors occur at a specific frequency, usually 4 – 7 Hz, and are most commonly associated with PD, but in some cases found in other movement disorders. Postural tremor occurs when a specific body part is held motionless against gravity, such as extending the arms out, pointing with the hands or sitting upright without back support. Postural tremor typically occurs at a frequency of 9 – 11 Hz and can be associated with PD or ET. Other types of tremor include kinetic tremor, which occurs during a voluntary movement such as writing, drinking or eating and intention tremor, which is unique in that is occurs during a visually guided movement toward a target destination.

Distinguishing tremor types and quantitative features is very important for research, clinical judgments and intervention efficacy. CleveMed has developed a device called Kinesia™ that can be used to detect and monitor subtle differences in tremor characteristics. Kinesia is a small wireless device worn on the patient’s finger and wrist to monitor three dimensional motion. Currently being evaluated in several clinical studies around the United States, this device is intended to help standardize tremor evaluations and provide clinicians with a tool to better quantify tremor features when the signs are too subtle for clinical differentiation alone. Improving and standardizing the clinical evaluation of tremor may ultimately improve the understanding of tremor subtypes, increase efficacy of interventions and maximize patient quality of life.

Night @ Room 101: Sapphire PSG collects sleep data in Sleep Lab

Day @ Room 101: Sapphire PSG (Full PSG Sleep System) easily tucked away in a supply shelf during the day.

They do say a picture is worth a thousand words! So here, I posted two doodles to better illustrate the following point: Sapphire PSG has successfully aided facilities in becoming multi-purpose spaces, since it’s small and can be easily stored away when not in use.

For example, a night-time sleep lab space can be used as a daytime clinic in the same facility.