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PainChek reveals progress for its pain assessment app in the US

Published: 13:46 09 May 2018 AEST

PainChek app
The app detects the presence of facial micro-expressions that are indicative of pain

PainChek Ltd (ASX:PCK) (www.painchek.com) has received a preliminary assessment from the FDA confirming that there is no substantially equivalent product to PainChek™ in the US and it may be suitable to apply for a De Novo (novel device) classification.

FDA has advised that the company will have to provide clinical performance data to support the pre-market submission.

PainChek is planning to engage with the FDA to review the currently available PainChek app clinical trial results and identify and agree to any additional clinical data required for the De Novo submission.

READ: PainChek takes strides toward commercialisation for e-health tool

PainChek uses cameras in smartphones and tablets to capture a brief video of the person, which is analysed in real time to detect the presence of facial micro-expressions that are indicative of pain.

This data is then combined with other indicators of pain, such as vocalisations, behaviours and movements captured to calculate a pain severity score.

Clinical studies in Australia have indicated that PainChek is a valid and reliable pain assessment tool for people with moderate to severe dementia, who can no longer self-report their pain.

Approved in Europe and Australia

The PainChek app already has TGA and CE Mark clearances that provide access to more than 40% of the global market including Europe and Australia.

PainChek team at the National Alzheimer’s Conference in Melbourne

The company’s commercial focus for FY18 and FY19 is in these markets.

PainChek chief executive officer Philip Daffas said: “We are pleased with this preliminary response as the FDA recognise PainChek™ as a novel medical device and we have experience of this process.

“The added benefits of conducting clinical trials in the USA, prior to commercial launch, includes engaging with major potential clients at an early stage that can accelerate the overall market development in the USA.”

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