Latest Medical Device Regulation News

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.

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.

OncoSil Medical reported a $15.1 million loss for FY25 amid strong revenue growth and significant regulatory milestones, supported by over $14 million in capital raises to fuel its global expansion.

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.

Tissue Repair Limited reports steady progress in its Phase 3 clinical trials for TR987® despite patient recruitment hurdles, while TR Pro+® sales surge and new distribution deals pave the way for international growth.

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.