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.

• Carl Zeiss Meditec wins PMA for expanded laser treatments
  Carl Zeiss Meditec Inc.’s MEL 80 Excimer Laser won pre-market approval from the FDA for the treatment of hyperopia. This new indication complements the existing FDA approved applications of the surgical laser for myopia and astigmatism.
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• Access Scientific wins FDA clearance for Powerwand
  Access Scientific Inc. received FDA 510(k) clearance for the Powerwand — an extended-dwell, power-injectable 3.1 inch IV catheter delivered by means of the wands’s Accelerated Seldinger Technique. The device is designed to "transform the in-patient experience, by allowing many if not most patients to have one and only one needlestick for vascular access throughout their hospitalization," according to the company.
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• EnteroMedics wins CE Mark approval for Maestro RC system
  EnteroMedics Inc. (NSDQ:ETRM) received CE Mark approval of its second generation Maestro RC System for the treatment of obesity using VBLOC vagal blocking therapy. The Maestro RC System, a pacemaker-like device, is designed to offer a patient-oriented obesity therapy that affects the physiology of hunger and fullness without forcing punitive, mechanical limits to lifestyle and diet, or requiring surgical alteration of the anatomy. The company plans to commercialize the Maestro RC System in Australia.
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