Latest Digital Health Innovation News

BlinkLab has expanded its pivotal FDA 510(k) autism diagnostic trial to nine top U.S. sites, adding Drexel University ahead of the Q1 2026 study start. This move follows a successful pilot study that exceeded FDA benchmarks, positioning BlinkLab Dx 1 for regulatory clearance.

BlinkLab Limited has appointed its Co-Founder and CEO, Dr Henk-Jan Boele, as Managing Director to steer the company through its pivotal FDA 510(k) trial for its autism diagnostic technology. The move coincides with key board changes and signals a strategic shift as BlinkLab prepares for early commercialisation.

Vitasora Health has secured AU$3.56 million from a cornerstone investor, issuing over 118 million shares, while confirming compliance with key regulatory disclosure obligations.

Oneview Healthcare reported robust commercial growth in 2025, driven by new US client wins and the launch of its AI-powered care assistant, Ovie. The company enters 2026 with a confident outlook focused on expanding its US footprint and advancing digital health innovation.

HeraMED has secured a pilot agreement with Lee Health, a leading US non-profit health system, to trial its HeraCARE digital maternity platform, aiming to transform prenatal and postpartum care through remote monitoring and virtual engagement.

HeraMED has bolstered its cash position with a $1.98 million capital raise and is on the cusp of finalizing two pivotal U.S. commercial agreements, signaling a major step forward for its digital maternity care platform.

Vitasora Health is set to scale its AI-powered chronic care services from Hawaii to 10-15 US states, leveraging a new partnership with Privia Health following Evolent Care Partners' divestiture. This expansion targets up to 30,000 patients and promises significant revenue growth in 2026.

Optiscan Imaging Ltd has launched a fully underwritten $17.75 million entitlement offer to fund clinical trials and regulatory clearances for its medical devices, marking a pivotal step in its transition to a commercial medical device manufacturer.

ResMed Inc. reported a robust 10% increase in revenue to $5.15 billion for fiscal 2025, driven by strong demand in sleep and breathing health devices and residential care software. The company also expanded its diagnostic capabilities with the acquisition of VirtuOx, positioning itself for further growth in home-based health solutions.

Advanced Health Intelligence Ltd has secured up to AUD 5.5 million from Oakley Capital Partners to support its ASX reinstatement and global growth ambitions, while targeting an additional USD 6 million from strategic investors and unlocking AUD 3 million in R&D grants.

Advanced Health Intelligence Ltd (AHI) reports robust commercial progress and strategic funding moves in Q1 2025 despite ongoing ASX trading suspension and recent NASDAQ delisting. Key partnerships and technology validations position the company for a strong global scale-up.

Advanced Health Intelligence has been formally delisted from NASDAQ due to shareholder equity deficiencies but is actively pursuing ASX reinstatement as a critical step toward regaining its dual-listing status.