Lifeshirt and Cybercare both received FDA 510K approvals ...
...anybody have any insights about how their products differ from STAY? What markets are they likely to target and how will this impact STAY?
Below are excerpts from their PRs this morning:
BOYNTON BEACH, Fla.--(BW HealthWire)--Aug. 30, 2000-- CYBeR-CARE, Inc. (Nasdaq:CYBR - news) announced today that it has received 510k market clearance (Regulatory Class II) from the FDA to sell in the United States its Electronic HouseCall(TM) (EHC500) system, a patented Internet-based technology that remotely monitors individuals in their homes for health care purposes. This model has a portable form factor, has self-contained wiring, has the same functionality as the EHC400 patient unit, and interfaces within the EHC network and the EHC600 provider unit. The EHC500 will be available in mid 2001.
The Electronic HouseCall(TM) system (EHC) allows full two-way audio and video communication between a patient and a caregiver 24 hours per day via CYBeR-CARE's patented technology. The EHC system collects patient's vital signs (such as temperature, blood pressure, blood oxygen content and pulse rate) and automatically records them in a central database within the network so that the caregivers have real clinical information about the patient's condition.
Linda L. Roman, Senior Vice President of CyberCare Technologies, Inc. stated, ``We are excited to be adding to our existing family of products the EHC 500, which will enhance our ability to manage a wider range of chronically ill patients. CyberCare's range of products are designed to meet our client's varied needs.''
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 transport services.
LOS ANGELES--(BUSINESS WIRE)--Aug. 30, 2000-- LifeShirt.com, (http://www.lifeshirt.com), the online vital signs monitoring company that uses a comfortable shirt with embedded sensors to continuously monitor a patient's vital signs, today announced that its research and development partner, Non-Invasive Monitoring Systems (OTC:NIMU - news) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an expanded indication of the core monitoring software known as ``RespiEvents(TM).'' Significantly, the FDA approval was received in less than 90 days from the initial application.
``This FDA 510(k) clearance for our ambulatory monitoring software enables the LifeShirt to gather vital signs as individuals sleep or engage in daily activities such as work or while exercising. This breakthrough establishes LifeShirt as a key player within the ever-evolving 'e-Health' space,'' said Andrew Behar, chief operating officer and founder, LifeShirt.com. ``This approval also marks a significant step forward in our efforts to bring the LifeShirt to market.''
RespiEvents(TM) is a software package that provides ongoing analysis of vital signs during waking and sleeping hours. The expanded indication allows for medically significant data that is currently monitored in hospitals to be gathered in an ambulatory mode. Specifically, it is intended to supply analysis of breathing patterns and to aid in identifying and classifying apnea and hypopnea based on lung tidal volume thresholds, displaying heart rate changes from electrocardiographic waveforms and displaying signals from physiologic recording devices such as a body position sensor and pulse oximeter. RespiEvents(TM) deploys ``Respitrace'' technology that was originated, patented and developed by Non-Invasive Monitoring Systems as the unsurpassed method for non-invasive measurement and analysis of respiration. LifeShirt.com is an e-health company. Its first product, the LifeShirt, is a comfortable garment with embedded sensors that was invented by Dr. Marvin Sackner, the company's medical director and CEO of Non-Invasive Monitoring Systems.
The LifeShirt continuously monitors and records more than 40 respiratory and cardiac physiological signs during work, play or sleep. The encrypted data is then uploaded for analysis. It was recently awarded U.S. patent 6,047,203, ``Physiologic Signs Feedback System'' and joined a portfolio of ten monitoring technology and software patents assigned to LifeShirt.com, Inc., from NIMS. This underlying technology is currently used in more than 1,000 hospitals worldwide including the Mayo Clinic, Johns Hopkins University Hospital and Los Angeles Children's Hospital and has been cited in more than 1,400 peer-reviewed scientific papers. |
