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. PRINCETON, N.J., Ma- Abbott announced today it has received clearance from the U.S. More from the company press release below: "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.Ībbott estimates that some 50,000 i-STAT devices are in use worldwide and they process about 100 million test cartridges annually. "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 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. 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 MedGadget. 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 Health Canada has cleared it for use in that country.Ībbott's device, however, is the newest connected medical handheld to join the growing list of FDA cleared medical tools. ![]() Ascom, Monica Healthcare and Mobisante have each received a 510(k) clearance this year for a connected medical device. 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.
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