Latest Medical Device Regulation News

BlinkLab Limited reported a substantial net loss of $5.7 million for FY2025, driven by intensive R&D and clinical trial activities, while securing $7.66 million in fresh capital to fuel its smartphone-based neurodevelopmental diagnostic platform targeting autism and ADHD.

Imricor Medical Systems reports significant regulatory approvals and clinical trial progress, positioning itself as a disruptive force in the growing electrophysiology market. With a strengthened commercial pipeline and solid cash reserves, the company is poised for a pivotal growth phase.

ResMed Inc. reported a robust 10% increase in revenue to $5.15 billion for fiscal 2025, driven by strong demand in sleep and breathing health devices and residential care software. The company also expanded its diagnostic capabilities with the acquisition of VirtuOx, positioning itself for further growth in home-based health solutions.

Osteopore Limited has posted a record AUD 835K revenue in Q2 CY25, driven by strong APAC sales and new European market access following EU MDR clearance. The company also advances clinical trials and refreshes key distribution channels.

Imricor Medical Systems reported significant regulatory and commercial progress in Q2 CY25, including CE mark approvals and expanded clinical trials, while maintaining a strong cash position.

BlinkLab is advancing its FDA 510(k) clinical trials for autism and ADHD diagnostics, completing its U.S. autism pilot phase and expanding European ADHD recruitment. A recent $7.66 million capital raise supports these efforts as the company targets regulatory approvals in 2026.

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.