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Medical technology company Emyria (ASX: EDM) has scored an Australian first following the registration of its smartphone-based heart monitoring application with the Therapeutic Goods Administration (TGA).
The inclusion of its app on the Australian Register of Therapeutic Goods (ARTG) as a Class IIa Software as a Medical Device (SaMD) follows reforms introduced to the sector in February due to the rise of software-based medical devices in recent years.
The TGA last month identified the need for regulation of these devices to ensure patient safety and introduced new guidance for manufacturers to keep them abreast of the legislated definition of a medical device.
A Class IIa classification applies to software that provides information for diagnostic or therapeutic purposes and any device lawfully sold in Australia must be registered on the ARTG.
The registration of Emyria's app paves the way for the company to use its real-world evidence software platform, known as Openly, to capture objective, clinical measures remotely during these upcoming clinical trials and projects.
Emyria says its medical-grade monitoring tool will open up further opportunities to remotely capture objective health data for its drug development, telemedicine and consumer healthcare projects.
"Obtaining this classification highlights Emyria's commitment to formal regulatory approval of novel drug treatments and technologies for unmet clinical needs," says Emyria managing director 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."
Under the Class IIa registration, Emyria's Openly platform is now recognised as being able to remotely capture medical-grade measurements of an individual's heart rate, heart rate variability and atrial fibrillation status. These measurements can determine signs of early infection, stress or mental distress.
"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," says Winlo.
"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."
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