Latest Medical Devices News

dorsaVi has inked a five-year sales agreement with Select Medical, opening access to over 1,900 US outpatient physical therapy centers for its FDA-approved motion analysis products. This follows a successful 18-month pilot validating clinical benefits in athlete rehabilitation.

Compumedics has secured FDA clearance for its single-use Somfit®D device, effectively doubling its addressable U.S. home sleep testing market to an estimated US$240 million annually. This milestone positions the company to capture significant market share with a dual-platform EEG-based solution.

Control Bionics Limited has announced a 1-for-5 non-renounceable rights issue to raise up to $2.06 million, aiming to fund the commercial expansion of its NeuroStrip® device and operational growth. The offer is partially underwritten and open to eligible shareholders in Australia and New Zealand.

Lumos Diagnostics has secured a significant follow-on contract with Aptatek Biosciences to push forward the development of an innovative in-home monitoring device for Phenylketonuria (PKU), a rare genetic disorder. This next phase aims to bring the FDA Breakthrough Device-designated PheCheck™ closer to clinical trials and commercial readiness.

Imricor Medical Systems has taken a significant step toward U.S. market entry by submitting its Vision-MR Diagnostic Catheter for FDA 510(k) approval, complementing its recent NorthStar system filing. These moves aim to establish a fully integrated MRI-guided cardiac ablation platform.

Vectus Biosystems has posted a 58% drop in revenue and a 24% reduction in operating loss for FY2025, but its net equity has swung into negative territory.

Uscom Limited reported a 25% decline in revenue to $3.16 million and a 59% increase in net loss to $3.3 million for FY25, reflecting significant global headwinds. Despite setbacks, the company advanced new product approvals and secured funding to navigate ongoing challenges.

Cardiex Limited reported a 10% revenue increase in FY25, driven by new product launches and significant cost reductions, positioning the company for growth in FY26 with strong backing from C2 Ventures.

Cardiex Limited’s FY2025 results reveal a sharp 67% revenue decline driven by the prior year’s one-off clinical trial payment, while net losses nearly doubled despite ongoing cost reduction efforts and significant capital raises.

Optiscan Imaging Limited reported a 17.6% revenue decline and a 4.1% increase in net loss for FY25, driven by lower orders and higher R&D spending. The company unveiled two new medical imaging devices as it ramps up commercial efforts.

Adherium Limited reported a $12.68 million net loss for FY2025 as it pivots towards commercialising its smart inhaler technology in the US, supported by a $4.49 million capital raise.

Next Science Limited reported a 7% revenue decline and a 20% reduction in net loss for H1 2025, alongside a major $50 million asset sale agreement with OSARTIS GmbH. The transaction, approved by shareholders, signals a strategic pivot for the biofilm-focused medical device company.