The FDA cleared Abbott's i-STAT 1 Wireless point-of-care blood analyzer last week, marking the fourth wireless-enabled medical device to receive FDA clearance so far this year. Ascom, Monica Healthcare and Mobisante have each received a 510(k) clearance this year for a connected medical device. The FDA has cleared more than a dozen software apps for mobile devices over the years including one this year: Mobile MIM, which just announced that for use in that country.
Abbott's device, however, is the newest connected medical handheld to join the growing list of FDA cleared medical tools. The wireless model improves upon the legacy wired i-STAT device by automatically transmitting readings to a central computer without necessitating that a physician synch with the device, according to .
"With i-STAT 1 Wireless, caregivers are able to share critical test information electronically without leaving the patient's bedside," Greg Arnsdorff, head of Abbott's point of care business, stated in the company's press release. "By empowering nurses to stay at the bedside, the new i-STAT 1 Wireless supports a patient-focused approach to treatment, allowing for expedited decision making that helps minimize time to treatment."
"With wireless, physicians can receive immediate test information in the electronic medical record, enabling them to act quickly when a patient's clinical status is rapidly changing," Arnsdorff stated.
Abbott estimates that some 50,000 i-STAT devices are in use worldwide and they process about 100 million test cartridges annually.
More from the company press release below:
PRINCETON, N.J., March 29, 2011 -- Abbott announced today it has received clearance from the U.S. Food and Drug Administration to begin marketing the i-STAT® 1 Wireless handheld, a new wireless version of the i-STAT® point of care testing system that is widely used in hospitals, emergency rooms and physicians' offices. The new i-STAT 1 Wireless handheld will allow real time transmission of diagnostic test results generated by i-STAT 1 directly from the patient bedside.
"With i-STAT 1 Wireless, caregivers are able to share critical test information electronically without leaving the patient's bedside," said Greg Arnsdorff, head of Abbott's point of care business. "By empowering nurses to stay at the bedside, the new i-STAT 1 Wireless supports a patient-focused approach to treatment, allowing for expedited decision making that helps minimize time to treatment."
The handheld analyzer can potentially save precious time by allowing caregivers to perform critical tests at the bedside and then transmit test results immediately so they can be reviewed by physicians anywhere they have access to electronic records. Eliminating back-and-forth movement from the bedside to a desktop transmission terminal somewhere in the department gives staff the ability to better focus on the patient.
"With wireless, physicians can receive immediate test information in the electronic medical record, enabling them to act quickly when a patient's clinical status is rapidly changing," Arnsdorff said.
With the 10-minute i-STAT cardiac troponin test cartridge, for example, emergency department staffs can test, transmit and treat from the bedside. This helps health care providers maintain compliance with testing guidelines from the American College of Cardiology and American Heart Association, which call for a turnaround time of less than 60 minutes. By sharing these test results via a hospital's existing wireless network, caregivers have rapid access to information that can help determine if a patient is having a heart attack.
The i-STAT 1 Wireless handheld is certified for compatibility with existing wireless networks. It is also is compatible with point-of-care data management systems used with earlier versions of the i-STAT System. The i-STAT 1 Wireless is the latest innovation from Abbott Point of Care, the U.S. market leader in bedside testing. The company offers the largest menu of diagnostic tests in a handheld platform and is used in nearly 2,000 hospitals in the U.S. and nearly 1,000 emergency departments.
About the i-STAT System
i-STAT 1 Wireless is a fully integrated system with a comprehensive test menu that enhances bedside testing workflow. The i-STAT System can aide the physician in accelerating patient care decision making by quickly providing patient results that can be acted upon. Weighing just 18 ounces, the intuitive analyzer needs only two or three drops of blood to provide lab quality results. Blood is added to disposable cartridges that contain test reagents; the cartridge is then inserted in the analyzer; and results are provided in minutes. In addition to cardiac markers, other i-STAT tests include chemistries, blood gases, electrolytes, and tests for lactate, hemoglobin, coagulation, and hematology. In the U.S., the i-STAT System is used in nearly 2,000 hospitals and in nearly 1,000 emergency departments. Some 50,000 i-STAT analyzers are used worldwide and process about 100 million test cartridges a year. The system is relied on by clinicians in emergency departments, intensive care units, operating rooms, catheterization labs, outpatient clinics and physician offices. Technical support is available 24 hours a day. To learn more, visit .
About Abbott Point of Care
Abbott Point of Care, headquartered in Princeton, N.J., develops, manufactures and markets critical medical diagnostic and data management products for rapid blood analysis. The company's premier product is the i-STAT, a market-leading handheld blood analyzer capable of performing a panel of commonly ordered blood tests on two or three drops of blood at the patient's side.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's website at .