FDA de novo clearance
As indicated by the FDA, the system can estimate pulse rate, heart rate, respiratory rate and/or breathing rates.
The Oxehealth Vital Signs system is installed in a patient's hospital room, where it can spot-measure pulse, heart, respiratory and breathing rates with no physical contact.
The IB-Stim device adheres behind the patient's ear for up to five days, and may assist with pain reduction for up to three consecutive weeks.
The Tandem Diabetes Care t:Slim X2 can work in tandem with other blood sugar management devices, or on its own.
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While the test offers information on whether or not certain treatments may be effective, the regulatory agency stressed that the results should never be used in care decisions.