Services

CuraCloud offers professional services to medical technology vendors, healthcare organizations, and pharmaceutical companies that need machine learning and bioinformatics research and development capacity. Our clients gain direct access to a top-tier research and development team with expertise in management consulting, machine learning, medical informatics, and regulatory strategy. These services result in client-owned solutions that solve unique clinical challenges.

Data Preparation

Our imaging analytics operations center provides cost-effective annotation and reporting services to our clients.

Image Annotation and Data Curation

Our imaging analytics operations center provides clients with cost-effective annotation and reporting services. DICOM image files are sent to the imaging analytics operation center where they are  processed by our trained technical staff under radiologist supervision. We offer customized services for research-related image annotations and reports, catering to our clients’ needs.

PHI De-identification

HIPAA requires organizations that receive Protected Health Information (PHI) to apply both technical and administrative controls to protect the security and privacy of this data. We have implemented such controls so that a dedicated, separated team can de-identify PHI in a highly controlled environment and then export it to a larger AI team in a PHI-cleansed state, thus limiting risks and allowing its use for research and other compliant applications.

AI Application Development

Our research and development team brings experience developing software medical devices for leading medical technology manufacturers around the world to every project. We can work with you to develop software for:

  • Computer-assisted diagnosis (CADx)
  • Computer-assisted detection (CADe)
  • Computer-assisted diagnostic quantification (CADq)
  • Computer-assisted triage (CAT)
  • Biomarker discovery (radiomics)

Machine Learning and Algorithm Development

Our AI scientists develop deep learning models that interpret medical data, including imaging data and electronic clinical reports. Utilizing our in-house GPU clusters, we quickly build AI engines using massive annotated datasets to detect, classify, segment, and measure diseases from images, as well as turn unstructured text reports into structured databases. We have filed more than 60 machine learning technology patents and published over 10 peer-reviewed scientific articles over the past four years.

Scalable SaaS Engineering

Our software engineering team has strong experience building applications using advanced user interfaces, scalable web server technologies, and cybersecurity for deployment across cloud, mobile, and other devices. Our quality management system is ISO 13485 certified and we have helped our client earn a CE mark for their software medical device.

Clinical Integration

Bringing AI into the clinical workflow often involves integration with PACS, VNAs, EMRs, DICOM routers, enterprise worklists, and other IT solutions. Accomplishing seamless integration requires expertise in technologies including RESTful APIs, HL7,FHIR, and proprietary interfaces. We bring in experts capable of solving interoperability challenges so that AI can be brought into practical use.

Clinical Validation Study Design

Our experience developing our own software medical devices has contributed to our body of knowledge about the design of clinical validation studies for software medical devices. We apply this experience to custom development projects for our healthcare clients.

Human-Centered Design

Our human-centered design team works with clients to deeply understand workflow, end-user needs, and other human factors in the design of AI solutions. This is a conscious break from the all-too-common practice of designing IT solutions without collaborating with those who use it.

Regulatory Strategy

Our team is skilled in helping clients bring products to market. We have helped our client gain a CE mark for their software medical device.

Regulatory Pathway Analysis

Our product development team has experience reviewing FDA device summaries and exploring alternative predicate devices for possible use in 510k submissions. This can be useful to clients who may need to pursue regulatory clearance or approvals for their software medical devices.

Recommended Resources

FDA Quality System Regulation
The USA Code of Federal Regulations (CFR) defines quality system requirements for medical devices, including software-only devices in Title 21, Chapter 1, Subchapter H, Part 820. This is commonly referenced as “21 CFR 820.” Regulations are subject to change based on new laws and the ongoing regulatory process. To get the most current version, visit the Electronic Code of Federal Regulations at www. Ecfr.gov, select title 21 (Food and Drugs), then the range beginning with 800.
US Food & Drug Administration Digital Health Software Pre-Certification (Pre-Cert) Pilot Program
International Medical Device Regulators Forum

The International Medical Device Regulators Forum (IMRDF) is a voluntary group of medical device regulators from around the world that discuss future directions in medical device regulatory harmonization.

In October 2015, the IMRDF published Software as a Medical Device (SaMD): Application of Quality Management System. This document defines SaMD lifecycle support, realization, and use processes. It is a strong reference that can inform development process improvement initiatives for SaMDs globally.

Our Process

Unique and Cost Effective

Existing commercial off-the-shelf (COTS) medical image analysis products are often limited. In-house agile development brings the advantages of being tailored, cost-effective, and uniquely valuable. By teaming with CuraCloud on internal development projects, the organization can get exactly what they find the most useful to their patients and to their customers.

Competitive Advantage for Healthcare Organizations

Healthcare organizations can accelerate their internal AI development by working with credible AI partners.

Our clients can directly deploy new capabilities in a compliant manner while creating evidence of clinical effectiveness for possible publication and/or for submission to the FDA as a software medical device.

Our clients may gain exclusive access to advanced clinical solutions. Combined with other innovations, AI can deliver a sustained competitive advantage for healthcare organizations.

Let's start something new together.