4DMedical, TrivarX, and Artrya Advance with FDA Clearances and US Partnerships
Key Insights
4DMedical (search)'s CT LVAS (search) receives FDA clearance, expanding functional lung imaging accessibility in the US after its Australian rollout.
TrivarX (search) accelerates its Phase 2 study for Major Depressive Episode (search), aiming to validate its MEB-001 (search) algorithm for screening and diagnosis.
Artrya (search) partners with Northeast Georgia Health Ventures to validate its Salix Coronary Anatomy (search) platform for detecting coronary artery disease (search) in the US.
Respiratory imaging tech company 4DMedical (search) (ASX:4DX) saw its share price jump after receiving FDA clearance for its CT-based ventilation product, CT LVAS (search). The clearance is expected to broaden patient accessibility to functional lung imaging in the US, following its initial rollout in Australia.
4DMedical's CT LVAS Gains FDA Clearance
The US represents a significant market for CT scanners, with 43 scanners per million people, according to OECD data. This clearance follows the US Centres for Medicare & Medicaid Services (CMS) approval of reimbursement for 4DMedical (search)’s XV LVAS at US$299 per procedure, effective January 1, 2024. 4DMedical plans to pursue a similar reimbursement strategy for CT LVAS (search), starting with an application to the American Medical Association (AMA) to establish a new Category III CPT code.
TrivarX Progresses Depression Study
TrivarX (search) (ASX:TRI), an AI-based medical device company, reported a rise in early trading after onboarding 15 sleep centers across the US to expedite its Phase 2 Sleep Signal Analysis for Current Major Depressive Episode (search) study (SAMDE). The study aims to validate the company’s algorithm, MEB-001 (search), in assisting the screening and diagnosis of current major depressive episode (cMDE). The company aims to enroll 400 patients and has successfully enrolled 132 patients to date. Clinicians will administer a Mini International Neuropsychiatric Interview (MINI) to establish ground truth regarding each patient’s cMDE status.
According to TrivarX (search)’s non-executive chairman, David Trimboli, the results will form the basis of TrivarX’s engagement with the FDA to unlock a regulatory pathway for their product, ahead of commercial rollout.
Artrya Enters US Market
Artrya (search) (ASX:AYA), another AI-focused medtech company, has entered the US market through a five-year strategic commercial partnership agreement with Northeast Georgia Health Ventures (NGHV). NGHV will collaborate with Artrya to validate Artrya’s Salix Coronary Anatomy (search) (SCA) platform within its workflow and hospital network, while the product undergoes the FDA 510(k) clearance process. The companies will also develop specific use cases for Artrya’s software products across the five hospitals under the network to validate the detection of coronary artery disease (search). Post-FDA clearance, NGHV will work with Artrya to expand its point-of-care SCA solution to clinicians and patients across the Northeast Georgia Health System, potentially helping 100,000 heart disease (search) patients each year. Artrya notes that heart disease kills one person every 34 seconds in the US, highlighting the market opportunity for its product.