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Emerging Partner

ProVoyance

FDA-cleared AI software for medical devices and surgical planning

Grand Rapids, Michigan, United States
1-10 employees
Verified
3 Certs

About ProVoyance

ProVoyance, operating under Genesis Software Innovations, LLC, is a Grand Rapids-based software development company specializing in FDA-cleared medical device software. The company creates custom AI and machine learning solutions that transform medical imaging into actionable clinical tools, with a stated mission to minimize invasive procedures.

The company's core competencies center on AI-assisted medical imaging analysis, real-time 3D visualization for surgical planning, and patient engagement platforms. Their flagship product, ProVoyance Shoulder, received FDA 510(k) clearance and enables surgeons to perform detailed pre-operative planning for shoulder arthroplasty using AI-generated bone reconstructions from CT scans. The platform is designed as an adaptable framework that can be extended to other anatomies and surgical procedures.

ProVoyance works collaboratively with medical professionals and device manufacturers to develop custom solutions that meet FDA requirements. Notable projects include a white-label patient engagement platform for digital health organizations and NSite, a radiation-free scoliosis screening tool developed in partnership with Stanford Medicine that is currently under FDA review.

Best For

ProVoyance is best suited for medical device manufacturers, orthopedic device companies, and digital health organizations seeking FDA-cleared software solutions that integrate AI/ML capabilities with clinical workflows. The company appears particularly well-matched for partners requiring custom surgical planning platforms or patient engagement applications with 3D visualization components.

Key Strengths

  • Proven FDA regulatory expertise with 510(k) cleared products already in market
  • Specialized AI/ML capability for converting medical imaging (particularly CT scans) into 3D surgical planning tools
  • Platform-based development approach that allows surgical planning technology to be adapted across different anatomies and procedures
  • Experience developing radiation-free alternatives to traditional imaging methods, as demonstrated with the NSite scoliosis screening tool
  • White-label solutions that enable healthcare organizations to brand patient engagement platforms as their own

Why Choose ProVoyance

Choose ProVoyance when you need a development partner with demonstrated FDA regulatory success and deep expertise in AI-driven medical imaging analysis. The company excels in situations requiring sophisticated 3D visualization, particularly for surgical planning applications where accuracy and clinical integration are paramount.

Expect a collaborative development process focused on creating platform solutions that can be refined and adapted based on clinical feedback. ProVoyance positions itself as nimble and responsive, working closely with medical professionals to ensure solutions meet both regulatory requirements and practical clinical needs.

Healthcare Focus

ProVoyance operates exclusively in the healthcare sector, specifically focused on medical device software and digital health applications. The company's healthcare specialization is evidenced by their FDA 510(k) clearance, partnerships with orthopedic device manufacturers, and collaboration with Stanford Medicine on clinical innovations.

Their work concentrates on surgical specialties (particularly orthopedics), diagnostic imaging, and patient engagement for clinical populations. All development follows FDA regulatory pathways, indicating deep understanding of medical device software requirements and clinical safety standards.

Ideal Client Profile

The ideal ProVoyance client is a medical device manufacturer or digital health company developing innovative surgical or diagnostic solutions that require AI-powered imaging analysis, 3D visualization, and FDA clearance. Organizations seeking to enhance existing medical devices with intelligent software capabilities or those developing radiation-free alternatives to traditional imaging methods would find strong alignment with ProVoyance's demonstrated expertise.

Specializations

AI/ML medical imaging analysis 3D surgical planning software CT imaging bone reconstruction Patient engagement mobile applications FDA-cleared SaMD development Medical device software integration Radiation-free diagnostic imaging

Client Types

Medical Devices Digital Health Healthcare Startups

Why Choose ProVoyance?

  • 1-10 team members
  • 3 certifications verified
  • Emerging Partner on Curatrix

Quick Facts

Headquarters
Grand Rapids, Michigan, United States
Company Size
1-10 employees

Certifications

fda 510(k) iso 13485 iec 62304

Profile last updated: Jan 25, 2026

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