Latest Medical Devices News

Universal Biosensors is expanding its handheld testing portfolio with the upcoming AQUASCOUT water sensor and growing sales of its FDA-approved Xprecia Prime blood coagulation device, targeting multi-billion-dollar markets.

Aroa Biosurgery has reported its first quarter of positive operating cash flow since listing on the ASX in 2020, alongside robust revenue growth projections and new regulatory approvals across key international markets.

OncoSil Medical has achieved a key regulatory milestone with MDR certification from BSI, removing post-market restrictions and streamlining its commercial operations across Europe. This approval also paves the way for renewed efforts to enter the Australian market.

EMVision Medical Devices reports strong progress in clinical trials for its emu™ Bedside Scanner, backed by robust cash reserves and strategic non-dilutive funding. The company is poised to commence pivotal FDA validation trials, marking a key step toward commercialisation.

EBR Systems has signed a long-term lease for a 51,000 sq ft facility in Santa Clara, California, positioning itself for significant manufacturing expansion and future growth in wireless cardiac pacing technology.

SomnoMed Limited reported a solid cash flow performance for Q4 2024, with operating activities generating a net inflow of $1.525 million and ending the quarter with $18.5 million in cash reserves.

SomnoMed reports a robust 19.8% revenue increase in Q2 FY25 and updates its full-year guidance, reflecting strong demand and operational improvements amid ongoing production enhancements.

Cardiex Limited has commenced U.S. deliveries of its CONNEQT Pulse arterial health monitor alongside the launch of its companion CONNEQT App, marking a pivotal expansion into the American digital health market.

Hydrix Limited has extended its contract with Paul Hartmann AG, adding $2.8 million in revenue and reinforcing its international growth strategy.

Imricor Medical Systems reports strong Q4 CY24 progress with successful FDA review, CE Mark submissions, and an 840% jump in consumables revenue, positioning the company for expanded global market penetration.

Compumedics has locked in a pivotal five-year contract with Philips Australia, cementing Somfit as the leading device for pharmacy-based sleep testing and underpinning significant SaaS revenue growth through 2028.

PolyNovo Limited reports a robust 22.8% revenue increase in 1H FY25, driven by strong U.S. and international sales growth and progressing FDA approval efforts for its NovoSorb platform.