Latest Fda News

CurveBeam AI reported steady progress in Q2 FY26 with five new device purchase orders, a $4 million milestone payment pending receipt, and key regulatory submissions underway in the US and China.

CurveBeam AI reported steady device orders alongside a $4 million milestone payment from its China commercialisation deal, while progressing FDA clearance and robotic surgery system validation.

Arovella Therapeutics has secured a crucial regulatory nod from the U.S. FDA, allowing its lead CAR-iNKT cell therapy, ALA-101, to enter first-in-human clinical trials targeting blood cancers.

dorsaVi reports strong US commercial growth with over 100 new physical therapy sites and a 50% rise in cash receipts, alongside a strategic leadership change and breakthrough neuromorphic technology acquisition.

Acrux Limited reports solid revenue growth and increased cash reserves in the December quarter, driven by expanding its topical generics portfolio in the US and strategic moves into female Hormone Replacement Therapy.

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.

ImpediMed reported a solid Q2 FY26 with $3.9 million in revenue and significant reimbursement gains for its lymphoedema technology, while launching new US Heart Health and Wellness initiatives.

Vitrafy Life Sciences has marked significant progress in Q2 FY2026 with a strategic partnership, commercial launch in North America, and advancing clinical trials, underpinning its growth in cryopreservation technology.

Chimeric Therapeutics reports encouraging clinical progress in its CAR-T and NK cell therapy trials, alongside FDA orphan drug designation and a strategic funding boost to propel development.

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.