Latest European Union News

OncoSil Medical’s PANCOSIL Phase 1-2 study reveals promising safety and feasibility for a novel CT-guided pancreatic cancer therapy, with survival outcomes exceeding historical benchmarks.

Imricor Medical Systems has successfully completed a comprehensive Human Factors study for all its devices under FDA review, marking a critical milestone towards U.S. market entry. The extensive 7-month study involved 46 healthcare professionals and tested nine products, underscoring Imricor’s growing momentum in electrophysiology innovation.

Memphasys has upgraded its contract with ITL to A$390,000 and expanded its territory to include Turkey, marking its first contracted revenues in the EU ahead of expected CE Mark approval.

Epsilon Healthcare’s manufacturing arm has secured updated GMP certificates covering domestic and EU/UK markets, reinforcing its quality credentials and paving the way for expanded international contract manufacturing.

AVITA Medical has secured the CE Mark for its innovative RECELL GO device, paving the way for commercialization across key European markets including Germany, Italy, and the UK. This regulatory milestone expands the company’s footprint in acute wound care.

Altamin Limited has been awarded a A$3.62 million refundable grant to advance its Lazio project in Italy, aiming to develop an innovative geothermal-powered process for extracting critical raw materials like lithium, boron, and sulphate of potash.

GreenX Metals has identified the Mid-European Crystalline Zone beneath the historic Richelsdorf copper mines in Germany, revealing a likely primary source of copper mineralisation and significantly boosting exploration potential at its Tannenberg Project.

Compumedics has secured FDA clearance for its single-use Somfit®D device, effectively doubling its addressable U.S. home sleep testing market to an estimated US$240 million annually. This milestone positions the company to capture significant market share with a dual-platform EEG-based solution.

Prospech Limited has announced a pro-rata renounceable entitlement offer aiming to raise up to $1.62 million to fund metallurgical testing and exploration at its Korsnäs rare earth elements project in Finland. The offer is partially underwritten and includes attaching options, reflecting the company’s ongoing development efforts and funding needs.

Imricor Medical Systems has taken a significant step toward U.S. market entry by submitting its Vision-MR Diagnostic Catheter for FDA 510(k) approval, complementing its recent NorthStar system filing. These moves aim to establish a fully integrated MRI-guided cardiac ablation platform.

Osteopore Limited reported a 6% increase in revenue to $1.56 million for the half-year ended June 2025, alongside a slight rise in net loss driven by expanded product development and compliance costs. The company secured key regulatory approvals and broadened its distribution footprint in Asia and the US.

Evion Group’s joint venture in India has made its inaugural shipments of expandable graphite to the US, capitalizing on rising global demand and supply shortages. The company also secures EU recognition as a preferred graphite supplier for critical industries.