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Automated external defibrillator maker CardioReady advises caution on the FDA's new regulatory proposals, urging that increased oversight not stand in the way of public proliferation.

MassDevice On Call

The FDA this month issued a new proposal on the regulatory oversight of automated external defibrillators, but at least 1 medical device maker is worried that enhanced oversight may harm public safety.

Philadelphia-based CardioReady, maker of AED systems, urged that the FDA ensure that any new oversight not jeopardize the proliferation of AEDs, in the interest of public health.

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