Latest Fda News

EBR Systems has secured FDA approval for its pioneering leadless WiSE CRT System and obtained key Medicare reimbursement endorsements, setting the stage for its commercial rollout. The company also completed a significant capital raise to support its market expansion.

Anteris Technologies reported solid clinical progress with 130 patients implanted with its DurAVR heart valve and is gearing up for its pivotal PARADIGM trial with 79 qualified sites worldwide. The company also strengthened its leadership with two new board members amid ongoing FDA engagement.

Anteris Technologies Global Corp. reported a $42.7 million net loss for the first half of 2025 amid advancing preparations for its pivotal DurAVR Transcatheter Heart Valve trial. The company’s recent IPO proceeds are fueling R&D and manufacturing scale-up as it targets regulatory approvals.

Island Pharmaceuticals has raised $350,000 through an options exercise by substantial shareholder MWP Partners, reinforcing confidence in its antiviral drug development pipeline.

Syntara Limited is set to update investors on the clinical progress of its lead drug candidate amsulostat, targeting myelofibrosis, in a webinar scheduled for 11 August 2025. The company highlights recent regulatory milestones and advancing trials.

Syntara Limited has received FDA guidance recommending a Phase 2 controlled trial for its lead drug amsulostat in myelofibrosis, setting the stage for a pivotal Phase 3 study. The company is poised to refine its clinical strategy while advancing a diverse pipeline with key data milestones ahead.

ResMed Inc. reported a robust 10% increase in revenue to $5.15 billion for fiscal 2025, driven by strong demand in sleep and breathing health devices and residential care software. The company also expanded its diagnostic capabilities with the acquisition of VirtuOx, positioning itself for further growth in home-based health solutions.

AVITA Medical has filed its Q2 2025 Form 10-Q, reaffirming its leadership in acute wound care with its FDA-approved RECELL System and expanding international footprint.

IDT Australia announces the immediate resignation of CEO Paul McDonald, appointing Executive Chair Mark Simari to lead as the company reports a 40.6% revenue increase but a widening net loss for FY25.

Atomo Diagnostics has secured a US$410,000 order from Lumos Diagnostics for its Pascal test cassettes, following Lumos's exclusive six-year US distribution deal for the FebriDx test with PHASE Scientific.

Nanosonics has secured FDA clearance for its next-generation trophon3 device and trophon2 Plus software upgrade, setting the stage for significant growth in the US medical disinfection market.

Mayne Pharma has firmly rejected a fresh termination notice from Cosette Pharmaceuticals alleging breaches related to FDA disclosure, escalating an ongoing contractual dispute with significant legal implications.