Latest Medical Devices News

EMVision Medical Devices is set to activate its sixth and final pivotal trial site at UCLA Health, advancing its emu™ brain scanner towards FDA submission. Meanwhile, the Continuous Innovation Study grows with the addition of Box Hill Hospital.

Nanosonics delivered a robust FY25 with 17% revenue growth and a 72% jump in profit before tax, propelled by next-gen trophon devices and advancing CORIS commercialisation.

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.

Imricor Medical Systems reported a sharp 52% revenue decline and a 92% increase in net loss for H1 2025, offset by a $42.8 million equity raise boosting liquidity. The company is investing heavily in European sales and clinical trials while pursuing FDA approval.

Polynovo Limited reported a robust 23.3% increase in total revenue for FY25, driven by strong commercial sales growth across the US and international markets. The company is advancing its FDA PMA submission and expanding its global footprint amid strategic product development.

PolyNovo Limited reported a robust 28.9% increase in group sales to A$118.6 million for FY25, alongside a 151% surge in net profit after tax to A$13.2 million, driven by strong U.S. growth and key regulatory approvals.

Universal Biosensors Inc. has been suspended from ASX trading following the appointment of voluntary administrators, highlighting serious financial distress within the company.

BrainChip Holdings reports a significant revenue surge and reduced losses in H1 2025, underpinned by new contracts, strategic collaborations, and an expanded funding agreement.

Atomo Diagnostics reports a significant expansion in its supply agreement with Lumos for the Pascal test cassette, tied to the promising CLIA waiver status of the FebriDx test in the US. This deal could nearly double Atomo’s revenues over the next three years.

Medical Developments International has reported a remarkable turnaround in FY25, posting a net profit after tax and securing paediatric approval for its flagship product Penthrox in Europe.

Medical Developments International Ltd reported an 18% increase in revenue to $39.1 million for FY25, returning to profitability with a net profit after tax of $0.1 million. The company advanced its Penthrox market expansion through regulatory approvals and new partnerships.

Fisher & Paykel Healthcare has issued strong first half FY26 guidance, forecasting significant revenue and profit growth while navigating new US tariffs. Meanwhile, director Pip Greenwood announces her retirement after eight years on the board.