Envisionit Deep AI, an artificial intelligence diagnostic radiology solutions specialist, has received 510(k) FDA clearance for its AI assisted chest x-Ray solution, RADIFY, under two critical pathologies.
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FDA approval
Envisionit Deep AI’s RADIFY Triage has officially been cleared to triage Pneumothorax and Pleural Effusion, two critical findings that represent significant challenges in emergency rooms and intensive care units.
RADIFY showed clinical accuracy in triaging both pathologies, within an average of three seconds to alert healthcare professionals. RADIFY’s aims to enhance the efficiency and effectiveness of medical professionals in emergency rooms and intensive care units. Envisionit Deep AI was established with a commitment to ethical AI principles. In alignment with this philosophy and to mitigate potential biases in AI, RADIFY underwent a thorough evaluation using diverse data and pertinent subgroup analysis through RATify, a standalone AI Validation and Quality Assurance tool in the company’s product suite. All the safety parameters of the device were verified in accordance with the software specifications and applicable performance standards and met the acceptance criteria (Device shows > 95% AUC).
Hugh Harvey, managing director Hardian Health, said: "In collaboration with Hardian Health, Envisionit Deep AI diligently showcased the device’s capacity to fulfil precise regulatory benchmarks. The rigorous FDA clearance process involved thorough clinical testing and evaluations, affirming the device's adherence to the utmost standards of accuracy and safety. Moreover, RADIFY was one of the first companies that underwent a meticulous evaluation against the FDA's new robust cybersecurity, rendering the approval even more gratifying."
Dr. Steven Holt, CEO, First Care Solutions, commented: “RADIFY’s ability to quickly triage pneumothorax and pleural effusion significantly reduces the time taken to alert ER doctors to critical pathologies that require urgent attention. This innovative solution is a game changer that will enhance the efficiency of doctors leading to better patient care.”
Dr Jaishree Naidoo, CEO at Envisionit Deep AI, added: “We are excited and proud to receive a 510(k) FDA clearance for RADIFY. This certification reaffirms Envisionit’s dedication to providing cutting edge technologies that elevate patient care and contribute to improved healthcare outcomes. At Envisionit Deep AI our commitment to innovation extends beyond just AI solutions, it encompasses ethical considerations and real-time validation as integral components of our mission to advance diagnostic healthcare. The timing of this regulatory approval coincides perfectly with Envisionit Deep AI’s imminent capital raise.”
