Latest Medical Technology News

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.

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.

4DMedical has secured $22.6 million through the exercise of deep in-the-money options, significantly strengthening its cash position to support the commercial rollout of its CT – VQ™ respiratory imaging technology.

Echo IQ reports a remarkable 153% increase in echocardiogram processing through its EchoSolv AS platform in the US, with a Mayo Clinic validation study nearing completion ahead of a critical FDA submission. The company is also advancing European market entry and strengthening its advisory team to accelerate global growth.

ImpediMed secures expanded insurance reimbursement for its SOZO platform, now covering over 301 million US lives and enhancing early detection of breast cancer-related lymphedema.

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.

Hydrix Limited delays its FY25 financial statements due to a pending independent valuation of its Wavewise Analytics shareholding, triggering an automatic trading suspension from 1 October 2025.

HITIQ Ltd has raised $250,000 through a premium-priced placement and secured a $1.4 million RDTI loan facility to support its pivot towards consumer concussion management technology.

Echo IQ has completed its presentation to the CPT Editorial Panel for a Category III CPT code for EchoSolv AS, with a decision expected from the American Medical Association in the coming weeks. Meanwhile, the company is advancing US deployments and FDA clearance efforts.