Radify Triage Cybersecurity FDA AI Request Response

The Problem

The client submitted a 510(k) to FDA for their AI/ML-enabled software-as a medical device. The FDA responded with a hold letter, or request for additional information, which included cybersecurity findings. They were looking for a regulatory consulting firm who:

• Had experience with FDA’s latest cybersecurity requirements
• Had experience in the radiology and AI/ML space
• Could begin the project quickly
• Could help address the findings with minimal overhead or changes to the existing product

The Outcome

Envisionit Derep AI® received 510(k) clearance 3 months after engaging with Innolitics.

The Solution

• Envisionit Deep AI® used its own RATify AI assurance and validation platform to conduct clinical evaluation study, completed all the required documentation as per FDA requirements, and submitted its 510(k) application.
• Envisionit Deep AI® shared the hold letter and relevant Cybersecurity and Software documentation, which has already been updated by Envisionit Deep AI® team in response to the hold letter, with Innolitics for review and comment.
• Innolitics reviewed the hold letter and relevant documentation, including the Cybersecurity Management Plan, Threat Model, and Cybersecurity Controls.
• Innolitics worked with the Client by guiding relevant updates to the documentation and drafting responses, as well as identifying the most efficient path forward, including highlighting opportunities to push back on FDA and save the team unnecessary work.
• Envisionit Deep AI® team enjoyed working with Innolitics, especially commenting on their knowledge of FDA guidelines and requirements.
• Envisionit Deep AI® plans to continue working together with Innolitics for future FDA regulatory needs.

About EnvisiontIt

Envisionit Deep AI® is an innovative medical technology SME in UK and Africa utilizing Artificial Intelligence to transform medical imaging diagnosis.

Dr. Jaishree Naidoo was in charge of pediatric radiology at a South African hospital in 2014 when she had a moment of epiphany after coming across a news story on the usage of AI recognition pattern in distinguishing animals.

As a radiologist with 20 years of experience, Naidoo was already familiar with pattern recognition, and she could immediately see how AI could be used in the industry to transform the access to diagnostic imaging.

The flame had been lit, and in 2019, together with Terence Naidu, and Andrei Migatchev, Naidoo launched Envisionit Deep AI®, a health tech startup that uses AI to bridge demand for diagnostic imaging.

Read more about EnvisionIt on TechCrunch →

About Dr. Jaishree Naidoo

Jaishree is a paediatric radiologist who has served the state health care system for 20 years. She has chaired the South African Society of Paediatric Imaging (SASPI), the African Society of Paediatric Imaging (AfSPI) and serves on the Executive Council of the World Federation of Paediatric Imaging (WFPI) and African Society of Radiology (ASR). She is an active researcher and speaker and has published widely on paediatric radiology. Dr. Jaishree Naidoo is a visionary leader in the field of radiology who is using AI to improve diagnosis and treatment of diseases, especially in children.