FDA fast-tracks Singular Health medical image handling software

The West Australian

Jan 13

Singular Health has jumped a major regulatory hurdle after winning fast-tracked Food and Drug Administration (FDA) clearance in the US for its 3DICOM MD Cloud, an innovative cloud-based imaging ...

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The new win now allows Singular Health to market and deploy its latest enhanced product across the United States for clinical use.Three stubborn problems continue to drag on the U.S. healthcare system - repeated medical scans, slow disease detection and patient data scattered across disconnected systems.Singular Health’s 3D medical imaging viewer and cloud-based software have been built specifically to break those bottlenecks, pulling scans from multiple servers into a single streamlined view to reduce duplication, save time and improve clinical outcomes.Singular Health estimates these aspects alone address a massive US$16.5 billion total market, a number derived from overall direct imaging costs of around US$236.5 billion.Under section 510(k) of the FDA’s Food, Drug, and Cosmetic Act, medical device makers must first knock on the regulator’s door before heading to market. That process involves lodging a pre-market notification, usually at least 90 days in advance, to prove that the new device is just as safe and works just as well as another device already on the market.If the FDA is satisfied, it grants clearance, opening the door to commercial sales. This pathway is commonly used for moderate-risk Class II devices such as Singular Health’s imaging platform.A key benefit of that pathway is that it is faster and less rigorous than full pre-market approval for higher-risk devices and no mandatory clinical trials are required in most cases - just evidence of equivalence and FDA reviews data of performance, safety, and testing.Unsurprisingly perhaps, Singular Health sailed through the process, with the FDA wrapping up its review in just 40 days - less than half the usual 90-day timeline – seemingly a clear nod to the quality and depth of the company’s regulatory submission.This clearance, achieved well ahead of time, represents a major milestone for Singular Health and our US. strategy. 3DICOM MD Cloud removes many of the traditional barriers to adoption by eliminating the need for hardware and complex desktop installations, while expanding modality coverage to include X-ray and ultrasound. This positions the Company to scale faster and drive greater impact in reducing duplicate imaging. Singular Health managing director and chief executive officer Denning ChongKey upgrades to the company’s 3DICOM MD Cloud include a fully browser-based, cloud-native design that eliminates the need for on-site hardware, complex IT setups or desktop installations.The platform now also supports a broader range of imaging modes, notably adding the most commonly-used X-ray and ultrasound imaging methods to the existing computerised tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) capabilities.The new features have effectively lowered the barriers to adoption for hospitals, clinics and multi-disciplinary groups, giving multiple medical facilities faster access, seamless collaboration and better sharing of medical images without logistical hurdles.A big part of that progress can be traced back to radiologist Dr Ronny Low, who serves as director of radiology training at Fiona Stanley Hospital in Perth and chairs the Royal Australian and New Zealand College of Radiologists’ CT Reference Group. Singular Health brought Dr Low on as a technical adviser during development of the new platform, tapping directly into his frontline clinical experience.The company says Dr Low helped refine clinician-informed workflows and shape a more intuitive, user-friendly interface designed for real-world use across multiple medical disciplines. He also played a key role in helping design a scalable architecture, positioning the platform to support future AI-driven features and an imaging marketplace as the technology continues to evolve.With a streamlined path to market now open, Singular Health appears well-placed to accelerate growth in the world’s largest medical imaging sector.The speedy FDA green light marks a pivotal step in Singular Health’s mission to unlock the full potential of medical imaging through accessible, user-friendly and interoperable technology.It is also likely to pave the way for reduced waste, enhanced collaboration between caregivers and ultimately provide better outcomes for patients across the U.S. and beyond.Is your ASX-listed company doing something interesting? Contact: matt.birney@wanews.com.au","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}