Latest Fda Clearance News

Artrya Limited has secured a five-year, US$0.6 million contract with Tanner Health, marking its inaugural commercial revenue in the U.S. market for its AI-powered Salix Coronary Anatomy platform.

Orthocell Limited has reported a record FY2025 revenue of A$9.19 million, driven by strong sales of its nerve repair product Remplir™ in Australia and a promising US market launch following FDA clearance.

BlinkLab has expanded its pivotal FDA autism diagnostic trial by adding the University of Nebraska Medical Center as a second U.S. clinical site, advancing toward broader validation and regulatory clearance.

EMVision Medical Devices has activated five of six pivotal trial sites for its emu™ bedside brain scanner, advancing towards FDA clearance while launching a parallel innovation study in Australia.

Echo IQ has initiated a pivotal clinical validation study with the Mayo Clinic Platform to test its EchoSolv HF software, marking the final step before its planned FDA submission in late 2025.

Artrya Limited announces a strategic leadership reshuffle with co-founder John Konstantopoulos stepping into the CEO role as the company prepares for its U.S. commercial launch of the Salix® AI-powered platform.

Orthocell Limited has posted a record quarterly revenue of A$2.73 million, driven by strong Australian sales of its nerve repair product Remplir™, with US market expansion poised to accelerate in FY26.

Cambium Bio has secured ethics approvals in Australia and the US to initiate pivotal Phase 3 trials of Elate Ocular, targeting moderate to severe dry eye disease, with patient dosing expected in October 2025.

BlinkLab has secured US Institutional Review Board approval to proceed with the main phase of its FDA 510(k) trial for an AI-powered autism diagnostic tool, marking a key step toward regulatory clearance.

Orthocell has marked a pivotal milestone with the first US surgical use of its Remplir™ nerve repair device following FDA clearance, setting the stage for commercial expansion in a $1.6 billion market.

Adherium Limited is raising up to $4 million through a partially underwritten entitlement offer to expand its US digital health platform and recruit key personnel. The capital raise supports scaling patient onboarding and advancing its FDA-cleared smart inhaler technology.

4DMedical has renewed and expanded its contract with Stanford University’s 3DQ Lab to include its innovative CT – VQ™ imaging technology ahead of FDA clearance, marking a significant step in its U.S. market expansion.