Emyria has received a Class IIa “software-as-a-medical-device” registration with the Therapeutic Goods Administration (TGA) for its medical-grade monitoring application using only a smartphone camera. The software platform can be used to monitor heart rate, heart rate variability and atrial fibrillation.
Running on Apple and Android phones, the monitoring tool opens up further opportunities for Emyria to remotely capture objective health data for its drug development, telemedicine and consumer healthcare projects.
Emyria plans to initially use the software platform to capture objective, clinical measures remotely during upcoming clinical trials and projects, including pursuing Schedule 3 registration for EMD-003, a cannabinoid-based medicine targeting psychological distress.
Emyria CEO Dr Michael Winlo said: “Obtaining this classification highlights Emyria’s commitment to formal regulatory approval of novel drug treatments and technologies for unmet clinical needs.
“Class IIa registration means Emyria’s Real-World Evidence platforms are now capable of capturing medical grade vital signs using just an Apple or Android smartphone.
“Emyria plans on using this capability in our upcoming drug development programs which allows our clinical teams to remotely monitor additional safety and efficacy outcomes data in our trial participants.
“We also believe this capability has applications in a variety of medical and consumer health monitoring settings where medical-grade remote monitoring can improve the care of patients with complex needs.”