Applied Cardiac Gets FDA Approval for Core Heart MonitorThursday, September 1, 2011
Laguna Hills-based medical device maker Applied Cardiac Systems Inc. has received regulatory clearance for a new product.
The Food and Drug Administration cleared Applied’s Core device, the company said.
Core is worn on a patient’s hip. It’s used for three types of cardiac monitoring —immediate EKGs; mid-range Holter monitoring, which monitors electrical activity; and a longer-term monitor that works up to 30 days and automatically detects heart abnormalities.
Core is “the bridge from the now to the tomorrow,” said Loren Manera, Applied’s chief executive and major shareholder, in an earlier interview.
The device is an example of a recently established field called telemedicine, which involves transferring medical information via interactive audiovisual media for remote examinations and diagnoses. Core sends signals to a receiving station that relays them to the wearer’s doctor.
Earlier, Applied, a privately held company that was established in 1981, said that it expects to post a pretax profit of $982,460 on revenue of $14 million.