CYBeR-CARE Receives FDA 510k Clearance to Market Its Electronic HouseCall 400 & 600 Systems.Business Editors/Health, Medical & Technology Writers BOYNTON BEACH Boynton Beach, city (1990 pop. 46,194), Palm Beach co., SE Fla., on the Atlantic coast; inc. 1920. A major suburban area, it is also a beach resort and vegetable-shipping point. , Fla.--(BUSINESS WIRE)--June 16, 2000 CYBeR-CARE, Inc. (Nasdaq:CYBR CYBR Copy Byte Right ) announced today that it has received 510k market clearance (Regulatory Class II) from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. to sell its Electronic HouseCall(TM) (EHC EHC Environmental Health Criteria EHC Environmental Health Center (NSC) EHC Eishockeyclub (German) EHC Extended Health Care (Plan) EHC Emory and Henry College 400 & 600) systems, a patented Internet-based technology Refers to the communications infrastructure of the Internet, which is based on the IP protocol. IP is part of the TCP/IP protocol suite. It may also refer to voice over IP (VoIP), which uses the Internet to make telephone calls. See VoIP, IP and TCP/IP. that remotely monitors individuals in their homes for health care purposes in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . Numerous independent industry studies have indicated that patient monitoring can significantly reduce patient health care costs, estimated at 35% - 40% annually, while improving care. The EHC systems allow full two-way audio and video communication between a patient and a caregiver 24 hours per day via CYBeR-CARE's patented technology. The Electronic HouseCall(TM) system also collects patient's vital signs (such as temperature, blood pressure, blood oxygen content and pulse rate pulse rate n. The rate of the pulse as observed in an artery, expressed as beats per minute. ) and automatically records them in a central database within the network so that the caregivers have real clinical information about the patient's condition. CYBeR-CARE intends to market the EHC units mainly to health care organizations which are at risk for the total costs of caring for chronically ill patients. These patients represent approximately one percent of the population, however, they are responsible for approximately one third of all health care dollars spent in the U.S. (expense per patient averages $70,000 annually), as well as in other countries. Insurance companies may save four to six times the amount they currently pay per patient per year as a result of the use of the EHC systems. John Haines, President of CyberCare Technologies, said, "Independent industry studies show that thousands of dollars per patient per year can be saved, after paying for all of the costs of the technology and the caregiver's time. This is an incredible value proposition for the payers and the patients alike. It not only saves a lot of money, but it does so while providing better care for the patients." "This is what the U.S. healthcare system has been waiting for," said Paul Pershes, President of CYBeR-CARE, Inc. "There is tremendous worldwide demand for this technology as demonstrated by the number of inquiries for the EHC systems that we have received. Now we will be able to provide the same benefits to U.S. customers as we will be providing to individuals in Asia, Europe and other markets." Based in Boynton Beach, FL, CYBeR-CARE is a technology assisted health management company with four business lines. The Company's Electronic HouseCall(TM) System, a patented Internet-based technology system provides for the remote monitoring of individuals for health care purposes. In addition, CYBeR-CARE operates physical, occupational and speech therapy centers, an institutional pharmacy and one of the world's largest air ambulance air ambulance Emergency medicine A helicopter or, less commonly, a fixed wing aircraft, used to evacuate a person who requires immediate medical attention that cannot be provided at his/her current location transport services. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995: The statements which are not historical facts contained in this press release are forward-looking statements that involve certain risks and uncertainties including but not limited to risks associated with the uncertainty of future financial results, additional financing requirements, development of new products, government approval processes, the impact of competitive products or pricing, technological changes, the effect of economic conditions and other uncertainties detailed in the Company's filings with the Securities and Exchange Commission. |
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