If continuous health monitoring in the home is to be successful, systems must require minimal interaction by the patient. Few people will accept hooking up to sensor wires, patches, or clips that can be inconvenient and uncomfortable. Apparently the FDA agrees, and recently granted the company Donisi a de novo clearance for its contact-free multiparameter biometric measurement system.
According to Donisi, the eponymous system represents 26 granted patents. Patients do not connect to the Donisi device by wire or patch. Instead of direct connections, Donisi uses proprietary optics to detect surface-level micro-vibrations. Artificial intelligence algorithms analyze the vibrations to evaluate the workings of internal organs such as the heart and lungs. The de novo clearance — used for novel technologies that are reasonably safe and effective — is for heart and respiratory rate measurements. Donisi has also submitted a pre-submission request (an earlier stage in the De Novo application process) for atrial fibrillation (AFib) sensing.
Again according to Donisi, the system simultaneously detects the multiple vital signs with medical-grade accuracy. The Donisi technology detects heart rate variability, stress, single lead ECG, respiratory rhythm, and pulmonary congestion.
The greatest advantage of the Donisi system is its ability to work without physical contact. This system is an important early indication of vital signs monitoring technology that could be used for remote patient monitoring (RPM) and for aging-in-place monitoring.
