Abbott wins CE Mark for i-Stat handheld blood tester

Abbott (NYSE:ABT) said today it won CE Mark approval in the European Union for its i-Stat Alinity handheld blood testing platform.

The i-Stat Alinity system is designed to perform a wide range of blood tests and analyses, including blood chemistries and blood markers. The company claims the device has the “largest menu of blood tests on a single device.”

“As a global leader in point of care testing, Abbott’s i-Stat Alinity builds on our rich diagnostics heritage to help healthcare providers deliver care when and where it’s needed. Whether in emergency departments, critical care settings or rural areas, i-Stat Alinity allows clinicians to make timely and informed treatment decisions that help people get back to better health,” Abbott point of care diagnostics VP Sharon Bracken said in a press release.

The device requires only 2 to 3 drops of blood, Abbott said, and can deliver results in between 2 and 10 minutes, with connectivity features to allow testing to be conducted in a variety of environments.

Features of the newly-cleared device include improved quality control, single-cartridge testing for multiple tests, wireless or wired connectivity and cloud connectivity, Abbott said.

Earlier this week, anti-trust regulators in the European Union granted conditional approval for the $25 billion merger of  Abbott and St. Jude Medical (NYSE:STJ).

The European Commission’s decision on the deal requires the divestiture of a pair of device lines: St. Jude must deal its Angio-Seal and Femoseal vascular closure assets, including a manufacturing plant in Puerto Rico, and Abbott must deal the Vado steerable sheath it bought with the acquisition of Kalila Medical earlier this year.

Happily for Abbott and St. Jude, those assets are already slated for a $1 billion sale to Japan’s Terumo (TYO:4543).

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