medical device News | The Market Online The Market Online – First with the news that moves markets. Breaking Australian stock market news, ASX 200 announcements and the latest ASX news today. Mon, 09 Sep 2024 02:12:50 +0000 en-US hourly 1 https://wordpress.org/?v=6.1.1 Control Bionics expands into UK and Irish markets with NeuroNode device https://themarketonline.com.au/control-bionics-expands-into-uk-and-irish-markets-with-neuronode-device-2024-09-09/ Mon, 09 Sep 2024 02:12:43 +0000 https://themarketonline.com.au/?p=714555 Medical device company Control Bionics Ltd (ASX:CBL) has secured an exclusive deal which will see its NeuroNode device distributed throughout the United Kingdom and Ireland through Smart Box Ltd – the UK’s premier provider of assistive technology.

NeuroNode is a wearable device which captures the brain signals being sent to skeletal muscles and transfers this input to a personal computer to enable speech and other functions, and through the agreement with Smart Box, it will now be made available to people with Motor Neurone Disease (MND), cerebral palsy and related conditions.

The contract will be for an initial term of two years, and will see Smart Box UK become exclusive distributor for the wireless product (and its Controller App).

Control Bionics CEO Jeremy Steele said the company was thrilled to see NeuroNode make it to the UK and Irish markets.

“This exclusive agreement marks an exciting step in our mission to empower people with severe disabilities to communicate and regain control of their lives through innovative technology,” he said.

“The NeuroNode has already been paired with hundreds of Smart Box devices and devices with Smart Box software around the world.

“We’re excited to extend this successful relationship to the UK and Ireland for the first time and look forward to building on this strong foundation to enhance the lives of users across these countries.”

“By leveraging Smart Box’s expertise and established network, we are confident that this partnership will accelerate the adoption of NeuroNode® across the UK and Ireland and improve the quality of life for countless individuals with speech and motorimpairments.”

The market seemed pleased with the news, and by 12:05 AEST, Control Bionics shares were trading at 9 cents – a rise of 3.45% since the market opened.

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Echo IQ tests show heart failure can be detected in 86% of cases with AI https://themarketonline.com.au/echo-iq-tests-show-heart-failure-can-be-detected-in-86-of-cases-with-ai-2024-09-03/ Tue, 03 Sep 2024 02:32:09 +0000 https://themarketonline.com.au/?p=713966 Medical technology company Echo IQ Ltd (ASX:EIQ) has seen its share price rise more than 11% as clinical tests showed its Heart Failure AI system accurately detected heart failure in 86% of patients.

Results of the two clinical tests – which were run in collaboration with St Vincent’s Institute of Medical Research and the University of Notre Dame in Fremantle – showed that if AI and clinical evaluation were combined, they could raise diagnostic accuracy to 97% among high-risk individuals.

This achievement is a crucial step for Echo IQ, which will be using these results for its FDA application to get its AI solution recognised as a diagnostic tool in the detection of heart failure.

Further underpinning the importance of these clinical tests was the presentation of their results at the European Society of Cardiology (ESC) Congress 2024 – the world’s largest and most renowned cardoliology congress.

Echo IQ’s Chief Medical Advisor Professor David Playford said the study results were a further step in confirming the viability of using AI in this context.

“The findings are compelling and illustrate the capacity of Echo IQ’s AI-backed technology to enhance the diagnostic skills of doctors,” he said.

“As a cardiologist, I am focused on improving the lives of my patients, and look forward to the opportunity to enhance my clinical skills with the use of AI solutions such as this.

“Heart failure is a major global health priority, and widespread application of Echo IQ’s heart failure AI has the potential to improve countless lives by improving the detection rates of heart failure.”

Shares in Echo IQ were trading at 16.7 cents at 12:26 AEST – a rise of 11.67% since the market opened.

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Webinar: What investors should know about what it takes for ASX-listed companies to get medical developments to market https://themarketonline.com.au/webinar-what-investors-should-know-about-what-it-takes-for-asx-listed-companies-to-get-medical-developments-to-market-2024-05-24/ Fri, 24 May 2024 05:31:42 +0000 https://themarketonline.com.au/?p=698660 The work of pharmaceutical companies can bring new hope to patients delivering solutions to unmet medical needs. It can also turn a small market cap play into a giant – but it’s a process that’s not easy, it’s risky and it can take a lot of money and patience.

Our webinar explores what it takes for ASX-listed companies to get new health care developments – whether that be drugs, apps or other technologies – through the complexities of Australia’s Therapeutic Goods Association approvals process.

Demystifying the clinical trials & approvals process

The TGA sits under the Federal Department of Health, and regulates the safety, efficacy and quality of everything from sunscreens to vitamin supplements, prescription medicines and medical devices. America’s big brother to the TGA is the US Food and Drug Administration. Some companies target the FDA first – looking to tap into a bigger market from the start.

Our webinar guests are:

Race Oncology (ASX:RAC) CEO Dr Daniel Tillett who joins us online. Race Oncology is advancing a reformulated version of bisantrene, namely RC220, to treat the likes of myeloid leukaemia, while avoiding heart damage which can be caused by other chemotherapies; Recce Pharmaceuticals (ASX:RCE) Chief Scientific Officer and co-inventor Michele Dilizia. Recce is in advanced testing of a patented antibiotic called R327. It’s being trialled in Australia and abroad for treating sepsis, UTIs and burns. The company has achieved Fast Track Designation by the FDA; And Brian Leedman from BlinkLab (ASX:BB1). BlinkLab’s launching FDA trials of a Princeton University-developed, AI-driven smartphone app to screen for autism and ADHD through a blink reaction test. Brian Leedman has plenty of experience with approvals – he was behind the ResApp Health cough analysis app that was sold to Pfizer in a $179 million deal.

We also feature insights from Bioshares editor, Mark Pachacz.

Bioshares is an online investor resource delivering research notes specific to Health Care sector companies. Bioshares also has a Biotech Summit which will be held in Fremantle, July 12-13.

While the TGA did not respond to our invitations to join the webinar panel, you can also look at our special report on the topic – which can be downloaded free from The Market Online here. The report is titled: What it takes to get a new drug to market in Australia – Demystifying the clinical trials and approvals process.

The material provided in this article is for information only and should not be treated as investment advice. Viewers are encouraged to conduct their own research and consult with a certified financial advisor before making any investment decisions. For full disclaimer information, please click here.

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