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.
Pain is usually an indication something wrong with the body and the typical approach to pain is to take appropriate medicine that will help alleviate that pain.
Theranica, an Israel-based biomedical technology company focused on developing advanced electroceuticals for migraine and other prevalent diseases, announced on May 28 that the U.
The Tandem Diabetes Care t:Slim X2 can work in tandem with other blood sugar management devices, or on its own.
Also: Literature review finds telehealth treatments to be on par with in-person care; Survey finds consumers' interest in wearables for health tracking grows.
Also: L’Oréal unveils UV sensor clip, companion app; Urinary incontinence wearable receives De Novo clearance.
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.
The FDA announced today that it will allow marketing of Natural Cycles’ contraception app in the US for pre-menopausal women aged 18 years and older.
The FDA announced yesterday that it will permit marketing of Viz.