xLM Enables Omniscient’s Breakthrough in Brain Mapping with FDA 510(k) domain
Omniscient leveraged xLM’s Continuous Validation services to achieve FDA 510(k) clearance for Quicktome, a brain mapping SaMD. xLM ensured AWS compliance and streamlined validation, accelerating approval. This partnership enabled Omniscient to revolutionize brain care, providing neurosurgeons with cutting-edge insights into neurological diseases and enhancing surgical decision-making worldwide.
When it comes to GxP compliance, speed and precision are non-negotiable.
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The Challenge
As a rapidly growing startup, Omniscient faced several critical hurdles:
- FDA Submission Pressure: Quicktome, a cutting-edge brain mapping platform, needed timely and fully validated documentation for FDA 510(k) submission.
- Complex Technology: Quicktome integrates advanced patient-specific neural network data, requiring precise validation to meet regulatory standards.
- Resource Constraints: With a lean team, Omniscient needed an experienced partner to accelerate compliance efforts without slowing innovation.
A fast, reliable validation process was essential to avoid costly delays and get the product to market quickly.
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The Solution
To meet tight timelines and compliance demands, Omniscient leveraged xLM’s Continuous Intelligent Validation platform.
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Key actions included:
- Automated AWS infrastructure qualification to support Quicktome’s cloud-based environment.
- Performed comprehensive software validation for Quicktome, ensuring alignment with FDA requirements.
- Delivered structured documentation ready for regulatory review, including validation planning and risk assessments.
- Provided flexible resource support, scaling efforts as Omniscient’s needs evolved throughout the project.
This approach kept Omniscient on track and audit-ready while allowing the team to stay focused on innovation.
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The Result
With xLM’s expertise and technology, Omniscient successfully:
- Completed validation in time for a successful FDA 510(k) submission.
- Maintained strict compliance while minimizing internal resource strain.
- Accelerated go-to-market timelines without compromising quality or safety.
- Built a scalable validation framework for future products and regulatory needs.
“Having a partner you can rely on when there’s a resource spike is important,”
said Henkin. “It allows you to meet deadlines without carrying a full team at all times.”
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Services Provided
- AWS Cloud Qualification
- Software Validation
- Validation Planning
- Regulatory Compliance