Latest Medical Device Regulation News

Osteopore Limited has gained Swiss market approval for its 3D-printed bioresorbable implants under the EU Medical Device Regulation, completing its European product portfolio and strengthening its partnership with Zimmer Biomet.

Imricor Medical Systems has secured key European regulatory approvals for its second-generation NorthStar system and initiated its commercial launch, while US FDA submissions progress amid some delays.

Imricor Medical Systems has secured CE Mark approval for its NorthStar Mapping System ahead of schedule, marking a pivotal shift to software-centric MRI-guided cardiac interventions across Europe and the Middle East.

OncoSil Medical has reported a remarkable 233% increase in dose sales for Q3 FY25, alongside significant regulatory approvals and strategic expansions that position the company for accelerated growth.

OncoSil Medical has secured new distribution agreements across key international markets and achieved critical regulatory milestones, while raising $8 million to fuel its growth in pancreatic cancer treatment.

OncoSil Medical has achieved a key regulatory milestone with MDR certification from BSI, removing post-market restrictions and streamlining its commercial operations across Europe. This approval also paves the way for renewed efforts to enter the Australian market.