FDA approval brings GE portable ECG to U.S.
The FDA has cleared GE Healthcare's MAC 800, a portable electrocardiogram (ECG) device based on cell phone technology, which will immediately be introduced into the U.S. market.
Originally developed and introduced in China in 2008, the portable device combines the keypad of a phone with a color display and diagnostic software, according to the company.
GE said that its MAC 800 is less than seven pounds, including the battery. The unit's integrated handle enables clinicians to carry it like a briefcase. Its lithium ion battery keeps it running for approximately two hours and takes four-hours to recharge.
According to the company, the MAC 800 fits the connectivity needs of most practices, including LAN, modem, SD card and serial port to store and send ECG data from any location. Also, the MAC 800 offers the option of a PDF or XML output for storing and data sharing, and connects to a variety of vendors' EMR solutions via Cardiosoft, GE's cardiology information software system, creating a digital ECG workflow.
Originally developed and introduced in China in 2008, the portable device combines the keypad of a phone with a color display and diagnostic software, according to the company.
GE said that its MAC 800 is less than seven pounds, including the battery. The unit's integrated handle enables clinicians to carry it like a briefcase. Its lithium ion battery keeps it running for approximately two hours and takes four-hours to recharge.
According to the company, the MAC 800 fits the connectivity needs of most practices, including LAN, modem, SD card and serial port to store and send ECG data from any location. Also, the MAC 800 offers the option of a PDF or XML output for storing and data sharing, and connects to a variety of vendors' EMR solutions via Cardiosoft, GE's cardiology information software system, creating a digital ECG workflow.