Latest Healthcare It News

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.

Beam Dental Bidco Pty Ltd has launched an unconditional $2.20 per share takeover bid for Pacific Smiles Group Limited, offering a 37.5% premium and aiming to consolidate full ownership. The offer is unanimously recommended by Pacific Smiles’ Independent Board Committee, with plans to delist the company from the ASX upon success.

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.

Pro Medicus Limited’s European arm, Visage Imaging, has landed a significant five-year, A$10 million contract to supply next-generation imaging technology to University Hospital Heidelberg and the German Cancer Research Institute, marking a strategic expansion in Europe.

Adamantem Capital Management has completed its due diligence on Apiam Animal Health and extended its exclusivity period to negotiate a potential $0.87 per share acquisition. The deal remains subject to approvals and binding agreements.

Immuron Limited has taken a significant step forward by submitting an Investigational New Drug application to the FDA for IMM-529, targeting Clostridioides difficile infection. The company aims to start Phase 2 trials in early 2026, addressing a critical unmet need in infectious disease treatment.

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.

Epsilon Healthcare Limited reported a $3.25 million loss for 2024, reflecting the financial strain of voluntary administration and efforts to rebuild operations and client confidence.

Micro-X Ltd has received a $5.08 million R&D tax incentive rebate for FY25, with an additional $0.31 million pending approval, reinforcing its innovation-driven growth in medical imaging technology.

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.

Unith Ltd reported an 18.8% increase in FY 2025 revenue to A$5.37 million alongside a significant capital raise, positioning itself for expansion in the burgeoning AI Digital Humans market.

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.