Latest Medical Technology News

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.

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.

Artrya Limited has successfully completed a strongly supported Share Purchase Plan, raising approximately A$5 million despite significant oversubscription. This follows a recent $75 million placement, underscoring investor confidence in its AI-driven coronary artery disease platform.

Micro-X has landed a $3.3 million order from the Malaysian Ministry of Health for its Rover Plus mobile X-ray units, marking a significant step in its Southeast Asian expansion. Delivery is set to begin in October 2025.

CONNEQT Health has disclosed significant revisions to its 2025 financial results, highlighting increased losses driven by a larger-than-expected fair value write-down on its inHealth investment and a heightened inventory provision.

CONNEQT Health has raised $2 million through a convertible note facility with a director-owned entity, providing fresh capital to support its growth plans. Shareholder approval will be key to unlocking the full benefits of this funding.