Latest Medical Device Regulation News

Memphasys has secured CE Mark approval for its Felix™ sperm selection system, enabling full commercial rollout across Europe and activating multi-year contracts worth over A$1.3 million. This milestone signals the company’s transition into a revenue-scaling phase with global growth ambitions.

Orthocell has lodged a regulatory application to distribute its nerve repair product Remplir™ across the EU and UK, aiming to tap into a $750 million market with approval expected by Q3 2026.

SDI Limited reported a steady FY2025 with a slight profit increase, driven by growth in aesthetic and whitening products and the launch of its new amalgam replacement, Stela. The company also announced plans for a new factory to boost production capacity.

AVITA Medical reported a 13% drop in Q3 commercial revenue to $17.1 million but improved its net loss and secured CE Mark approval for RECELL GO in Europe, signaling strategic shifts ahead.

Bioxyne Limited, through its subsidiary Breathe Life Sciences, has inked an exclusive deal to import, manufacture, and distribute Curaleaf’s Que Medical Inhalation Device in Australia, with a nationwide launch set for November 2025.

Osteopore Limited reported a 7% year-on-year revenue increase in Q3 CY25, secured Swiss market approval for its implants, and saw a threefold sales surge through its Zimmer Biomet partnership.

Mach7 Technologies reports a pivotal first quarter for FY26, marked by the initial go-live of a major U.S. Veterans Health Administration contract, leadership changes, and a strategic business reset.

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.