About Globus Medical

Globus Medical: Healthcare imaging in 2030. Engineered today.

Globus Medical is building connected, cybersecure, evidence-anchored Medical Imaging & Diagnostic Systems for the next decade of hospital capital planning.

Roadmap

Roadmap to 2030

  1. SBOM-by-default

    Software Bill of Materials disclosed for every Class II imaging platform with networked interfaces.

  2. HL7 FHIR R5 deep integration

    Native bidirectional imaging order/result flows with Epic, Cerner, and MEDITECH pathways.

  3. SaMD Predetermined Change Control

    Class IIb image-analysis models auto-update under FDA Predetermined Change Control Plan filings.

  4. Remote-commissionable imaging

    Field engineers arrive for hardware unboxing; calibration and protocol packs complete remotely.

  5. Carbon-aware installed base

    Net-zero operations planning across Globus Medical deployed imaging rooms with take-back programs.

Milestones

Recent engineering milestones

  1. Initial FDA-cleared AI-assisted radiology reading module entered portfolio review

  2. De Novo classification pathway evaluated for novel SaMD imaging aid

  3. FDA Breakthrough Device Designation track for advanced reconstruction workflow

  4. MDR 2017/745 conformance package for connected imaging line

  5. Predetermined Change Control Plan filing for ML reconstruction updates

Clinical collaborators

Reference-style collaboration markers

Institution marks below are illustrative placeholders for visual layout—not claimed endorsements. Named hospital testimonials are withheld unless a written authorization is on file.

Academic medical center mark Imaging research institute mark National health system mark University hospital mark Regional health network mark

What the roadmap does—and does not—claim

  • Evidence anchors: FDA 510(k) clearances, De Novo evaluations, Breakthrough Device tracks, and MDR 2017/745 packages are cited by pathway and year; each is product-specific.
  • QMS anchors: ISO 13485:2016 design controls, ISO 14971 risk files, IEC 60601-1 / 60601-1-2 EMC, and UDI labeling are maintained in the device master record (DMR) / design history file (DHF).
  • Limits: Roadmap items for 2027–2030 are engineering targets, not guaranteed commercial release dates. SaMD auto-update requires cleared Predetermined Change Control Plan scope. Net-zero operations planning does not equal site-level carbon neutrality for every installed room.
  • Interoperability: Epic / Cerner / MEDITECH pathways describe integration checkpoints; they are not certified endorsements unless a separate interface agreement states otherwise.

Co-develop the next-generation imaging workflow with Globus Medical.

Bring your archive strategy, Tesla / slice-class needs, and cybersecurity questionnaire—we will map documentation, not oversell outcomes.

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