Latest Medical Devices News

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 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.

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.

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.

Universal Biosensors Pty Limited has entered voluntary administration with KPMG appointed as administrators, signaling urgent financial distress and a potential restructuring ahead.

Universal Biosensors has extended the due diligence period with major investor Viburnum Funds as it continues to negotiate a secured loan facility, with no binding commitment yet reached.

ReNerve Limited has achieved a key milestone with its first sale and clinical use of a deep dermal tissue product in the US, broadening its surgical applications beyond nerve repair. This move complements its existing nerve repair portfolio and sets the stage for further product launches later this year.

ResMed Inc has updated the foreign exchange rate for its forthcoming dividend payable to ASX-listed CDIs, setting the Australian dollar payout at 9.24 cents per CDI. This adjustment reflects the latest USD to AUD exchange rate and carries important tax implications for investors.

EMVision Medical Devices has been awarded a $3 million non-dilutive government grant to conduct a pioneering clinical study using its telehealth-enabled emu™ brain scanner in regional South Australia, aiming to transform stroke diagnosis and treatment.