Philips receives FDA premarket approval for its HeartStart FR3 and HeartStart FRx automated external defibrillators
June 23 2020 - 9:00AM
June 23, 2020
Amsterdam, the Netherlands and Cambridge, MA
– Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in
health technology, today announced that the Center for Devices and
Radiological Health (CDRH) of the U.S. Food and Drug Administration
(FDA) has granted premarket approval (PMA) for the company’s
HeartStart FR3 [1] and HeartStart FRx [2] automated external
defibrillators (AEDs), and their supporting accessories, including
batteries and pads.
The HeartStart FR3 is a professional grade AED with advanced
features to help medical personnel and first-responders treat
cardiac arrest. The HeartStart FRx is a public-access AED that
features intuitive, step-by-step voice instructions, including
cardiopulmonary resuscitation (CPR) guidance, for emergency use in
workplaces, schools and other public spaces, as well as for medical
professional use.
“We are pleased to receive premarket approval for our HeartStart
FR3 and HeartStart FRx AEDs,” said Arman Voskerchyan, Business
Leader Therapeutic Care at Philips. “This complements the premarket
approval that we received last year for our HeartStart OnSite and
HeartStart Home AEDs. Our industry leading portfolio of AEDs is
instrumental in helping save the lives of numerous sudden cardiac
arrest victims in the U.S. and worldwide. We look forward to
continuing to meet our commitment to our medical professional and
public-access customers, and especially to the victims of sudden
cardiac arrest who rely on our AEDs.”
FDA PMA information for the HeartStart FR3 and HeartStart FRx
defibrillators can be found here and here, respectively. These
devices have been marketed to date under FDA premarket
notifications (510(k)), but are now approved under PMA.
In 2019, Philips received PMA approval for its HeartStart OnSite
and HeartStart Home defibrillators, which are the only
over-the-counter AEDs available to consumers in the U.S.
[1] Model 861388 and Model 861389[2]
Model 861304
For further information, please contact:
Steve KlinkPhilips Global Press OfficeTel. +31 6
10888824E-mail: steve.klink@philips.com
Kathy O’ReillyPhilips Global Press OfficeTel.: +1 978 221
8919E-mail: kathy.oreilly@philips.comTwitter:
@kathyoreilly
About Royal PhilipsRoyal Philips (NYSE: PHG,
AEX: PHIA) is a leading health technology company focused on
improving people's health and enabling better outcomes across the
health continuum from healthy living and prevention, to diagnosis,
treatment and home care. Philips leverages advanced technology and
deep clinical and consumer insights to deliver integrated
solutions. Headquartered in the Netherlands, the company is a
leader in diagnostic imaging, image-guided therapy, patient
monitoring and health informatics, as well as in consumer health
and home care. Philips' health technology portfolio generated 2019
sales of EUR 19.5 billion and employs approximately 81,000
employees with sales and services in more than 100 countries. News
about Philips can be found at
http://www.philips.com/newscenter.
- Bystanders use HeartStart AED
- HeartStart FRx and FR3
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