Philips Gets FDA Nod For First OTC Defibrillator, Plans TV/Print Ad Campaign
This article was originally published in The Gray Sheet
Executive Summary
Philips Medical expects its HeartStart Home non-prescription AED to become increasingly affordable for consumers as production volume ramps up
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Medtronic, Philips Offer Observations On AED Oversight
The required pre-approval FDA inspections for Class III devices add "no additional value" to FDA's regulatory oversight of automated external defibrillators, Medtronic says in written comments to the agency
Medtronic, Philips Offer Observations On AED Oversight
The required pre-approval FDA inspections for Class III devices add "no additional value" to FDA's regulatory oversight of automated external defibrillators, Medtronic says in written comments to the agency
Defibrillator OTC
Philips Medical's HeartStart OnSite will join the HeartStart Home as the first defibrillators available to consumers without a prescription beginning in early February. Additional over-the-counter availability will make defibrillators more accessible to communities, schools and businesses for implementing early defibrillation programs, according to the company. Both devices received FDA clearance in September 2004 (1"The Gray Sheet" Sept. 20, 2004, p. 16)...