Hoana's got a 520(k) and a fancy product name to go with it: the LG1 Intelligent Medical Vigilance System (trademarked, of course). (Press release)

The LG1(TM) system is a patient safety technology that tracks heart
rate, breath rate and whether the patient is in bed or trying to exit
the bed. The technology uses highly-advanced digital signal processing
(DSP) software algorithms. As a technology platform, this can
ultimately be implemented in a number of applications in healthcare,
not only in the acute-care setting, but elsewhere.

Hoana is targeting med-surg units in hospitals for initial sales. The target market opportunity is 8,000 hospitals with a total of about 1 million med-surg beds. Their technology provides the ability to monitor patients without any wires or sensors placed on the patient, and through more pervasive monitoring (Hoana would like you to equip all your beds with their product) avoid most “failure to rescue” situations.

Dr. Patrick Sullivan, CEO of Hoana Medical, states, “Under a controlled
research study in a commercial hospital, clinical testing demonstrated
LG1's ability to alert a nurse that a patient was crashing at 3:00am,
which may have gone unnoticed until the morning shift. It may have
helped save the patient's life.”

Hoana was founded in 2001 as a spin-off of Oceanit Laboratories, a
Hawaii-based engineering, science, and research company. Hoana's
PSA(TM) technology was developed for the US military as part of a
MEDEVAC platform to measure vital signs under battlefield conditions.

You can find a previous post on Hoana here.