Philips Obtains FDA Pre-market Authorization for its HeartStart Home Defibrillators and HeartStart OnSite Defibrillators

Koninklijke Philips N.V. a global leader in electronics and healthcare, recently revealed that the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration has ratified the company’s premarket approval submission for the products related to defibrillator segment which includes HeartStart Home Defibrillators and HeartStart OnSite Defibrillators and as well as the applicable accessories including pad electrodes and batteries.

It has been notified that Philips’ HeartStart Home defibrillators and Philips’ HeartStart OnSite defibrillators are the only OTC automated external defibrillators accessible to the consumers based in North America especially in the U.S., whereas on the other hand, HeartStart Home Defibrillators is the only automated external defibrillators focused on home environments. Arman Voskerchyan – Business Leader at the Therapeutic Care Division at Philips stated that, “We are committed to delivering high quality, innovative AEDs to provide personalized therapy to victims of sudden cardiac arrest”. He further added that the premarket approval of HeartStart Home defibrillators and HeartStart OnSite defibrillators available in the U.S. resembles vigorous work of his team that supplied the in-depth clinical, technical and as well as the production data incorporated in the PMA filing for these medical devices.

The worldwide defibrillators market has achieved substantial growth over the past few years. The market is likely to attain 1.7x growth in terms of revenue in the next 10 years as per study conducted by one of the market research firm. Various awareness and training programs along with technological advancement into this area is projected to fuel the market growth.

Daniela is America News Hour journalist and an expert in Finance, agricultural investments, economics, financial markets, new media, international relations & politics. Daniela has been a writer and editor for the past 11 years. She started out as a freelance content writer. Today, her articles have been picked up by major and local news sources and websites such as the CNET, Engadget, BuzzFeed and many more.

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