Latest Medical Device Regulation News

dorsaVi has commenced development of Sensor V6.5, a firmware upgrade that embeds intelligence directly within its wearable sensors, reducing latency and paving the way for future neuromorphic computing integration.

Alcidion has secured regulatory approval for its AI-powered clinical tool in Australia and the UK, paving the way for commercial rollout in its largest markets. This milestone strengthens its position in healthcare technology and opens new sales avenues.

Mach7 Technologies reports a positive operating cash flow in Q2 FY26, securing its first customer for the new Flamingo Architecture product and advancing key strategic initiatives.

Memphasys Limited has achieved its first material revenues following CE Mark approval for its Felix™ System, activating multi-year contracts across Europe, the Middle East, and Asia. The company is now transitioning from regulatory preparation to global commercial rollout with a focus on recurring revenues.

BlinkLab Limited has secured independent scientific validation for its smartphone-based autism diagnostic technology through publication in the prestigious journal Autism Research, marking a significant milestone ahead of its FDA regulatory trial.

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.