4DMedical Receives TGA Approval For XV Lung Ventilation Analysis Software (XV LVAS)

8 October 2020

Release date: 30 September 2020


  • The Australian Therapeutic Goods Administration (TGA) has approved 4DMedical’s XV Lung Ventilation Analysis Software (XV LVAS) for inclusion in the Australian Register of Therapeutic Goods (ARTG)
  • XV LVAS utilises the Company’s proprietary XV Technology™, which converts sequences of X-ray images into four-dimensional quantitative data by using patented mathematical models and algorithms
  • XV LVAS is 4DMedical’s first Software-as-a-Service (SaaS) offering and can provide immediate benefits to Australian physicians and patients, including assisting in the ability for physicians to diagnose respiratory diseases earlier and with more sensitivity while using existing hospital and clinical equipment
  • As a result of TGA Class 1 approval, 4DMedical is now well positioned to progress the global rollout of XV LVAS having received FDA 510(k) clearance in May 2020

4DMedical Limited, a medical technology company focused on commercialising its patented respiratory imaging platform, is pleased to announce that the Therapeutic Goods Administration (TGA) has approved 4DMedical’s XV LVAS offering for commercial sale in Australia. Utilising the Company’s XV Technology™ platform, XV LVAS converts sequences of X-ray images into four-dimensional quantitative data allowing physicians to better diagnose and treat patients with respiratory diseases.

Supported by more than 15 years of development in Australia, 4DMedical’s XV Technology™ seeks to improve the capacity of physicians to diagnose and treat patients with respiratory diseases, by providing objective measurements of regional lung motion and airflow.

Having received TGA Class 1 approval for its XV LVAS offering, the Company intends to define a path for immediate adoption of its SaaS product and supply of the software to departments of health, laboratories, medical practitioners and health care professionals in Australia. This follows the FDA 510(k) clearance the Company received for XV LVAS in May 2020 and continues momentum in the global rollout of 4DMedical’s flagship technology.

The Company is extremely pleased to be able to offer the benefits from its world-class technology to Australians, having conceptualised, designed and tested the technology in Australia.

Andreas Fouras, Founder & CEO of 4DMedical said:

“We are extremely pleased to announce TGA approval for our XV LVAS offering ahead of schedule, allowing us to offer our world-class technology to our own backyard in Australia. This is an endorsement of the value of government support for Australian technology companies as we have evolved our technology that was seeded at Monash University, funded via National Health and Medical Research Council (NHMRC) grants, spun out and subsequently raised capital from Australian investors.

“To be able to commercialise and offer our software to the Australian market as an Australian technology story is a truly exciting moment for myself and the team. We now look forward to bringing better outcomes for doctors and their patients through our unique and non-invasive imaging technologies that enable unprecedented insight into pulmonary function.

“Whilst the US market will continue to be our focus as the largest respiratory market, Australia is our home and we believe we can now move quickly to get traction through leveraging our hometown advantage and relationships faster than any other market.

“We are now establishing a sales and marketing team to deliver customers in 2021. This is significantly ahead of schedule and something that we are extremely passionate about, making a difference to the Australian healthcare system where we can leverage existing equipment to dramatically improve patient outcomes.”

The global respiratory diagnostic market is worth an estimated US$31 billion per annum and dominated by three procedures; pulmonary function tests, X-rays and computed tomography (CT). 4DMedical’s XV Technology™ platform provides compelling advantages that can aid market adoption:

  • Provides a non-invasive modality for physicians to understand regional lung motion and airflow, and to identify respiratory deficiencies earlier and with greater sensitivity;
  • Designed to be fully compatible with existing hospital and clinic equipment, therefore not requiring any capital expenditure; and
  • Will be delivered through a cloud-based SaaS model, allowing 4DMedical to deliver its technology more quickly and at a lower cost base than existing procedures.

Read the full media release via 4DMedical.


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