Melbourne-based Elenium Automation has become the first company to be granted regulatory approval for its fever detection kiosk, HealthGate as a medical device.

HealthGate, designed and manufactured in Australia, offers automated and highly accurate health screening for entry into public facilities such as healthcare centres, event venues and workplaces. It also incorporates health declaration technology prior to arrival at a facility. The system uses a proprietary multi-spectrum sensor array, which leverages artificial intelligence to detect the appropriate region of interest on a person’s face and accurately measure if they have a fever.

“HealthGate takes accurate readings of specific areas on a person’s face like the inner canthi or the tear duct, where the blood vessels are near the surface of their skin. This is more likely to show whether a person has a fever,” he said.

HealthGate detects a potential fever in under two seconds and eliminates the potential for human error in administrating the health screening process. The solution does not require an operator, meaning that staff are not being put in harm’s way.

Rather than requiring people to make contact with common surfaces like touchscreens or buttons, HealthGate is entirely touchless through cutting-edge voice recognition and virtual touchscreen technology, ensuring a hygienic experience.

HealthGate is designed to drive behavioural change in a post-pandemic world, where the public is more sensitive to infectious illnesses like the seasonal flu. A recent consumer survey of 1000 Australians commissioned by Elenium Automation1 revealed that 88 per cent of people are more likely to be honest about whether or not they feel unwell if they know they will undergo a health screening before being allowed entry to an event.

The survey also showed the vast majority – 83 per cent of Australians support the use of such new health screening technology to help mitigate the risk for themselves and their loved ones.

“By combining the health declaration with fever detection technology, HealthGate will influence and drive behavioural change with the public. As Lou Gerstner, the ex-CEO of IBM once famously said – people don’t do what you expect, they do what you inspect,” Mr Hornlimann said.

Many Australians are surprised to learn that any digital temperature monitoring device must be approved by the regulator as it is classified as a Class IIa medical device. To emphasise the importance of this requirement, board directors and senior management are personally liable for the health and safety of their employees under new workplace legislation. Deploying a solution which is not approved places the public at a higher level of risk.

“I’m sure most businesses don’t realise they’re potentially using uncertified devices,” said Mr Hornlimann. “That means the entry kiosks that have previously been deployed to determine whether or not someone is showing signs of fever are illegal for use in Australia.”

Any temperature measuring product for use on humans for the intended purpose of screening potentially febrile individuals must meet the legal definition of a medical device and is required to comply with the Australian regulatory requirements set out in the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) and the Therapeutic Goods Regulation 1990. Some of these uncertified devices incorporate low-resolution imaging approaches to check the average warmth of someone’s entire face not specific areas which are more likely to represent if a person is febrile.

HealthGate was listed on the ARTG on February 16, 2021, ARTG number 355032 and also received CE marking approval for medical devices in Europe. Elenium Automation received an A1 compliance rating for its quality management system, its highest rating, as assessed by the Therapeutic Goods Administration, the federal regulator for medical devices.
The implementation of Elenium’s Quality management system and submission to the TGA was led by CMSscidoc, with support from Branwoods CKC.

For more information, visit https://www.eleniumvitals.com.au.