Analogic Receives 510k Approval for LIFEGARD II Non-Invasive Patient Monitors
June 28th, 2005 | Published in Company Profiles
Analogic is moving to market
(press release) with 5 new patient monitors targeting the hospital or
in non-acute environments such as a freestanding clinic or physician’s
office.
patient monitoring offerings. The first release consists of five
models. The basic units measure five parameters, while other models
also monitor continuous non-invasive cardiac output and end-tidal CO2.
Units come equipped with integrated printers for recording waveform and
parameter values. The first models of LIFEGARD II are scheduled to be
released this summer and additional models with cleared capabilities
are to be made available over the next 18 months.
Analogic is clearly targeting lower acuity areas outside the ICU with
these low end monitors. Surprisingly, no connectivity features are mentioned in the press release. The Philips C1 vital signs monitor manufactured by Analogic does have a serial port, so I'm assuming these monitors do as well.
UPDATE: David Kutas from Analogic was kind enough to email me to let me
know that there is an RS232 port on their new family of monitors along with USB. He also
informed me that the links to FDA documents that were in this post are for a previous
generation of products; the FDA documents for Lifegard II have yet to be posted.
UPDATE: Analogic's 510k has hit the FDA database, you can view their MDR record here.
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