Latest Fda Approvals News

PainChek has secured FDA-regulated medical device status, enabling US Remote Therapeutic Monitoring reimbursement and opening a major US growth avenue. The company targets musculoskeletal pain management in non-verbal dementia patients, a largely underserved market.

Imricor Medical Systems has achieved a major milestone with FDA clearance for its NorthStar Mapping System, the first MRI-native 3D cardiac mapping platform approved in the US. This approval positions Imricor at the forefront of MRI-guided cardiac procedures in the world’s largest electrophysiology market.

Cleo Diagnostics has broadened its U.S. market opportunity to around 2 million women annually and is on track to complete its pivotal clinical trial early this year, supported by a $5 million capital raise and regulatory progress.

Patrys Limited has acquired Reliis, gaining a promising injectable formulation of quetiapine aimed at treating delirium with a rapid FDA approval pathway. This move positions Patrys at the forefront of addressing a significant unmet medical need in critical care.

Imricor Medical Systems has achieved multiple world-first procedures using real-time MRI guidance for cardiac ablation, advancing clinical trials and regulatory progress amid a strategic commercial expansion.

Epiminder Limited has successfully listed on the ASX, raising $125 million to commercialise its FDA-approved Minder device. The company has initiated the first US implant and secured five leading medical centres for its DETECT study.

LTR Pharma has marked a key milestone with over 1,000 SPONTAN prescriptions under Australia’s Special Access Scheme and is advancing clinical trials and US market preparations for its erectile dysfunction treatments.

Following its December 2025 ASX debut and a successful IPO, Saluda Medical reports robust global revenue growth and expands its US sales force, prompting an upward revision of its FY26 revenue guidance.

LTR Pharma has initiated dosing in its Phase II clinical trial for SPONTAN, a rapid-acting intranasal spray targeting erectile dysfunction, marking a key step toward FDA approval and commercial expansion.

Imricor Medical Systems has secured Virginia Commonwealth University Health as the third US site for its VISABL-AFL clinical trial, advancing its FDA approval pathway for MRI-guided cardiac ablation technology.

Orthocell Limited has reported a record $3.2 million revenue for the December 2025 quarter, marking its seventh consecutive quarter of growth, fuelled by expanding sales of its nerve repair product Remplir in the US and other international markets.

Tetratherix has inked a global exclusive distribution agreement with healthcare giant Henry Schein, paving the way for its first bone regeneration product, Tegenix, to enter major markets in 2026. Concurrently, the company has begun building an advanced manufacturing facility to meet expected global demand.