Heal

Biomedical Systems

Clinical software, diagnostics, AI-assisted decisions. Cannot ship without regulator clearance.

The need

Heal.

Ageing populations and clinical-labour shortages are pushing more care into clinical software, diagnostics, and AI-assisted decision tools. A scan is misread. A treatable condition is caught late. An AI tool is deployed in a clinic without evidence that it works, and a patient pays the price.

Tier 1: device licensing, clinical software clearance, digital health frameworks. Tier 2: clinical safety reporting, AI risk management for medical devices.

The filter

20 regulations mapped. 19 T1. 1 T2.

Of those, 3 have effective dates between 2024 and 2030.

Effective dates

When the filter takes effect.

3 2024202520262027202820292030

In-flight regulations across the four markets, by effective year.

Source: hmm Ventures regulatory dataset.

MarketRegulationTierEffective
AUTGA SaMD Regulation ReformT12027
JPPMDA AI Medical Device Fast-Track ExpansionT12027
SGHSA Digital Health Regulatory Framework ExpansionT12027

Source: hmm Ventures regulatory dataset.

The cohort

1,269 companies mapped to the Biomedical Systems Necessities.

Each mark is one company in the four-market dataset. Highlighted marks are the named exits already on the dataset.

1,269 Biomedical Systems companies. Highlighted marks: named regulated-company acquisitions.

Across the four markets

  1. Australia Named exit

    Eucalyptus

    Tier 1. Acquired by Hims & Hers Health. 2026.

    $240M cash · up to $1.15B total

    Telehealth licensing + ACHS accreditation across AU/UK/DE/JP/CA

  2. Japan In-flight regulation

    PMDA AI Medical Device Fast-Track Expansion

    Tier 1. Effective 2027.

    Status: in flight.

  3. New Zealand Named exit

    Medtech Global

    Tier 1. Acquired by Banyan Software. 2025.

    Undisclosed

    Healthcare IT / patient management system compliance

  4. Singapore In-flight regulation

    HSA Digital Health Regulatory Framework Expansion

    Tier 1. Effective 2027.

    Status: in flight.

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