Latest Medical Technology News

Lumos Diagnostics reported steady quarterly revenue with a 300% surge in product sales, driven by its flagship FebriDx® test. The company inked a landmark US$317 million exclusive U.S. distribution agreement and awaits FDA feedback on its CLIA waiver application.

Imricor Medical Systems made significant regulatory strides with FDA submissions for its MRI-guided cardiac ablation devices and launched NorthStar commercially in Europe, even as it reported increased cash outflows in Q3 CY25.

4DMedical secures a major commercial breakthrough with Stanford University adopting its FDA-cleared CT, VQ™ technology, while its partnership with AstraZeneca rapidly scales lung screening across Brazil.

PolyNovo Limited reported a robust 33.3% increase in Q1 FY26 sales, driven by strong U.S. growth and a remarkable surge in NovoSorb MTX sales. The company also completed key infrastructure projects, positioning itself for further expansion.

Imricor Medical Systems has completed the world’s first Pulsed Field Ablation procedure under real-time MRI guidance, marking a breakthrough in cardiac ablation technology. This pre-clinical success validates their Vision-MR platform’s adaptability and sets the stage for safer, radiation-free heart treatments.

PolyNovo Limited has appointed Bruce Peatey as its new CEO, bringing extensive international healthcare experience to drive the company’s next growth phase. Peatey’s leadership is expected to accelerate PolyNovo’s expansion into new markets and outpatient care.

Compumedics has secured a $2.15 million placement to fast-track commercialisation of its Somfit D device following early FDA approval, positioning the company for significant growth in the US home sleep testing market.

PainChek Limited has secured its first US customer, Jewish Home Family, just days after receiving FDA De Novo clearance for its AI-powered pain assessment app, marking a significant step into the $100 million US aged care market.

Artrya Limited has successfully navigated a key FDA Q-Submission meeting, receiving clear guidance on the regulatory pathway for its Salix Coronary Flow module, with a 510(k) submission planned by year-end.

PainChek Limited has achieved a landmark FDA De Novo classification for its PainChek Adult App, positioning it as the first regulated medical device for pain assessment in the US aged care sector and opening a $100 million annual market opportunity.

Cyclopharm Ltd has been hit with legal proceedings by 4D Medical Limited, accusing it of making false and misleading statements during a March webinar. Cyclopharm denies the allegations, calling the claim without merit.

Echo IQ’s application for a Category III CPT code was declined by the AMA, but the company is exploring reconsideration and new AI-specific coding frameworks to advance US reimbursement.