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Emerald Clinics higher as Openly App registered by TGA as medical device

The Openly technology extends Emerald’s real-world-evidence (RWE) platform and aids Emerald’s clinical team to provide remote health and wellness screening for patients and workforces.

Emerald Clinics Ltd - Emerald Clinics receives TGA registration for Openly App
The TGA registration highlights Emerald’s commitment to meeting the highest regulatory standards

Emerald Clinics Ltd (ASX:EMD) is trading higher after having its Openly App registered with the Therapeutic Goods Administration (TGA) as a class-1 medical device.

This came after the company completed a detailed self-assessment process of the platform.

Shares have been a much as 23% higher to 10.5 cents intra-day.

Monitoring service

The company developed Openly as a digital health and wellness monitoring service that can be provided through smart mobile devices and backed by Emerald’s clinical team.

Openly is incorporating world-leading smartphone technologies which, once validated, will enable the collection of contactless vital signs.

“Best-in-class health”

Chief executive officer Dr Michael Winlo said the Openly technology would help Emerald’s clinical team deliver best-in-class health and wellness screening which were becoming a high-priority for workforces looking to get back to business post-COVID.

“Openly helps collect relevant, real-world clinical information from individuals remotely and presents it to a clinical team who can act on that information.

“TGA registration demonstrates our commitment to generating the highest level of real-world evidence and allows us to provide health and wellness screening services, powered by smartphone technologies but backed by an experienced clinical team.”

The TGA assesses medical devices before they can be approved for use in Australia.

Devices must be included on the TGA’s Australian Register of Therapeutic Goods (ARTG) before they can be lawfully sold in Australia.

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