Medical Device Daily
Cardiac Science (Irvine, California) said it has received regulatory approval from China’s State Food and Drug Administration (SFDA) to sell its latest line of automatic external defibrillators (AEDs), including the Powerheart brand public-access AEDs and the Powerheart CRM, a bedside monitor that automatically treats hospitalized cardiac patients who suffer life-threatening heart rhythms.
The approval provides clearance for Cardiac Science to begin shipments of its G3 series AEDs into China under the Powerheart and FirstSave brands, as well as under GE Healthcare’s (Waukesha, Wisconsin) Responder brand name, which Cardiac Science manufactures on a private-label basis for GE.
Cardiac Science-branded AEDs operate in the Chinese language and are sold through its local Chinese distribution partners. The GE Responder brand AEDs are marketed in China by GE Healthcare.
The AEDs are initially expected to be deployed primarily in medical and emergency rescue settings and used by hospitals, physicians and paramedics on fire vehicles and ambulances. More than 100 Powerheart CRMs are currently in use in Chinese hospitals.
Cardiac Science said that historically, as new markets for its products have developed, medical and first responder segments have been the first to deploy AEDs, followed by more widespread adoption for installation in government institutions, transportation, corporations and other public places where citizens congregate.
Chairman and CEO Raymond Cohen said Cardiac Science has gained what he termed “a solid market share position” in emerging AED markets around the world, with inter- national sales now accounting for about 40% of the company’s revenue.
“People all over the world are recognizing that AEDs offer an effective and inexpensive way to protect citizens against sudden cardiac arrest,” Cohen said. “While the U.S. market continues to lead the way in the awareness and adoption of AEDs, we believe the international market now accounts for over 20% of worldwide AED sales.”
He said that China, “which represents a large potential market for us,” joins an extensive list of countries where the company’s latest-generation Powerheart AED G3 line is approved for sale, including other Asia/Pacific countries such as South Korea, Thailand, New Zealand and Australia, as well as dozens of countries in Europe, South America and the Middle East. “We plan to pursue our business aggressively in these countries,” Cohen said.