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.
The Solution
To meet tight timelines and compliance demands, Omniscient leveraged xLM’s Continuous Intelligent Validation platform.
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.
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.”
Services Provided
- AWS Cloud Qualification
- Software Validation
- Validation Planning
- Regulatory Compliance