Universal Meditech Receives FDA Approval for HeartStarter 3000
March 8, 1990
(Business Wire)
Mountain View, Calif. -- Universal Meditech, Inc., a medical device company, today announced that the U.S. Food and Drug Administration (FDA) has approved the HeartStarter 3000, the first automated external defibrillator (AED) that is approved for use by laypeople.
The HeartStarter 3000 is a portable device that can be used to deliver an electric shock to a person's heart who is experiencing sudden cardiac arrest. Sudden cardiac arrest is the leading cause of death in the United States, killing about 250,000 people each year.
The HeartStarter 3000 is about the size of a briefcase and weighs about 15 pounds. It contains a computer that analyzes the heart's rhythm and determines if a shock is needed. If so, the computer automatically delivers the shock.
The HeartStarter 3000 is designed for use by laypeople, such as people who work in businesses or schools where sudden cardiac arrest is a risk. The device has a voice-activated instruction system that guides the user through the process of using the device.
"We are very pleased that the FDA has approved the HeartStarter 3000," said John Fialka, chairman and CEO of Universal Meditech. "This approval is a major milestone for our company and for the fight against sudden cardiac arrest. We believe that the HeartStarter 3000 has the potential to save thousands of lives."
Universal Meditech plans to begin marketing the HeartStarter 3000 immediately. The device is expected to be available in businesses, schools, and other public places in the coming months.