Latest Fda Regulatory Approvals News

Memphasys has locked in a three-year exclusive distribution agreement for its Felix™ sperm separation system in Thailand, targeting a key IVF market with 110 clinics and 20,000–30,000 cycles annually. The deal adds approximately A$430,500 in contracted revenue, lifting South-East Asian minimum contracts to about A$1 million and contributing to FY2026 Felix™ sales now exceeding A$3 million.

Tetratherix Limited has marked a pivotal quarter with a $25 million ASX listing, an exclusive licensing agreement with Bio Optix for ophthalmic devices, and progress on FDA regulatory submissions for its prostate spacer product.

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.