Emyria gains TGA approval for Openly medical grade, smartphone enabled, cardiovascular monitoring software

Emyria Ltd (ASX:EMD) has achieved class IIa 'Software as a Medical Device' registration on the Australian Register of Therapeutic Goods from Australia’s 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. 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. With this Class IIa registration, Openly is now recognised as being able to capture medical-grade measurements of an individual’s heart rate, heart rate variability and atrial fibrillation status, remotely. The new product is titled 'Smartphone camera home cardiovascular monitoring application software' and runs on both Apple and Android phones. Capable of capturing vital medical signs Managing director 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.” Contactless management tool  By leveraging the capabilities of an individual’s smartphone, one can overcome the significant challenges of obtaining, distributing and maintaining standalone medical hardware. Remotely captured vital sign measurements complement patient-reported outcomes data by providing objective measures of physiological status. These data can be provided to a clinician to support clinical management decisions and referral thresholds as well as support ongoing analysis of the safety and efficacy of novel treatments. The TGA approval of the expanded functionality of the Openly platform provides a unique opportunity to remotely monitor patients in clinical studies, provide telehealth services to patients and enable other consumer healthcare products. Software-based medical devices are rapidly gaining importance as platforms, such as Apple’s HealthKit, extend the accuracy and utility of expensive, hospital-based medical equipment. Emyria plans to use Openly to remotely capture objective clinical measures from patient’s during pivotal and landmark clinical trials and projects in planning. Initially: EMD-003 (targeting psychological distress); EMDMA-001 (targeting PTSD); and EDICT - “An advanced digital monitoring and engagement platform for at-risk and confirmed COVID-19 individuals”. TGA assessments The TGA assesses medical devices before they can be approved for use in Australia and devices must be included on the Australian Register of Therapeutic Goods before they can be lawfully sold in Australia. 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 and attracts a higher level of scrutiny. Manufacturers of Class IIa medical devices must also obtain conformity assessment certification from an independent body (eg, the TGA) prior to inclusion in the ARTG. Emyria’s Class IIa classification applies to a unique software development kit (SDK), developed with technology partner Happitech. The SDK can be incorporated into Emyria’s smartphone applications and Real-World Evidence platforms. Emyria is the exclusive sponsor of this registration and will continue to work with Happitech to develop additional medical-grade cardiovascular and respiratory monitoring functionality for the platform.