Emyria have received an Australian-first, Class IIa “software-as-a-medical-device” (SaMD) registration with the Therapeutic Goods Administration (TGA) for a unique smartphone-based, medical-grade, heart rate (HR), heart rate variability (HRV) and atrial fibrillation (AF) monitoring application using only a smartphone camera, powered by Happitech.
According to Emyria’s Managing Director, Dr Michael Winlo, “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”. Dr Winlo proceeded to discuss how this application has capabilities that have yet to be applied, “In a variety of medical and consumer health monitoring settings where medical-grade remote monitoring can improve the care of patients with complex needs.”
Openly is Emyria’s remote Real-World Evidence (RWE) technology platform and was initially developed as a contactless, remote COVID-19 screening and management tool using just a smartphone. Now by leveraging the capabilities of an individual’s smartphone, one can overcome the significant challenges of obtaining, distributing and maintaining stand-alone medical hardware.
The TGA assesses medical devices before they can be approved for use in Australia. Devices must be included on the ARTG before they can be lawfully sold in Australia. Emyria’s Class IIa classification applies to the unique software development kit (SDK), developed using Happitech technology.
A Class IIa classification applies to software that is intended to provide information used to make decisions with diagnostic or therapeutic purposes. Successful classification as a Class IIa device requires passing detailed verification and clinical evaluation procedures.
Happitech will continue working with partners such as Emyria, the exclusive sponsor for this registration, to develop additional medical-grade cardiovascular and respiratory monitoring functionalities across various applications and platforms.
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