Zoll lands FDA clearance for automated external defibrillator

February 8, 2013 by MassDevice staff

Zoll Medical wins 510(k) clearance for its AED Plus CPR-assist technology.


Asahi Kasei (TYO:3407) subsidiary Zoll Medical won 510(k) clearance from the FDA for its fully-automated AED Plus device, which improves on the former semi-automatic model.

The new automated external defibrillator allows emergency responders to pre-program a shock instead of pushing the "shock" button.

"Like the semiautomatic AED Plus, the fully automatic version guides rescuers through the complete chain of survival, helping all sudden cardiac arrest victims, not just those who need a shock," president Jonathan Rennert said in a prepared statement.

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The clearance from the federal watchdog agency comes on the heels of Japanese Ministry of Health approval of Zoll's temperature regulation device, the first of its kind to win Shonin approval.