FDA clears Abbott’s wireless handheld testing system | Regulatory roundup

The FDA granted Abbott Laboratories (NYSE:ABT) 510(k) clearance for the wireless version of its i-STAT 1 point of care testing system.

Healthcare providers use the Abbott Park, Ill.-based company’s handheld i-STAT 1 device to transmit diagnostic test results from the patient directly to electronic health records where doctor can access the data.

"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," head of Abbott POC business Greg Arnsdorff said in prepared remarks.

Abbott said its 10-minute i-STAT cardiac troponin test cartridge, which gives emergency department staff the ability to test, transmit and treat potential heart attack patients from the bedside, is one example of the system’s POC capabilities for increasing the pace of care.

About 50,000 i-STAT devices are in use worldwide and they process about 100 million test cartridges a year, according to the company.

Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.

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• EnteroMedics wins CE Mark approval for Maestro RC system
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