Imvaria Bags FDA Green Light For Diagnosing Idiopathic Pulmonary Fibrosis

Imvaria, a company that specializes in the development of artificial intelligence, has filed a request for de novo clearance from the Food and Drug Administration (FDA) for a digital diagnostic that examines chest CT scans for the presence of idiopathic pulmonary fibrosis.

The startup company, situated in Berkeley, California, claims that the approval of its Fibresolve software is the first time that the agency has given its approval to a specialist diagnostic instrument specifically designed for lung fibrosis of any kind. In advance of any invasive tissue biopsy operation, it is intended to assist in distinguishing idiopathic pulmonary fibrosis from other chronic lung disorders. 

More About Idiopathic Pulmonary Fibrosis

• Idiopathic pulmonary fibrosis is a disease that leads to scarring of the lungs.
• It causes lungs to become stiff, making it hard for patients to breathe
• The lung damage it causes gets progressively worse with time
• To help manage IPF, patients should keep a healthy diet, remain active and use oxygen therapy.

Joshua Reicher, the company’s CEO, stated, “Fibresolve serves as an adjunct to clinicians in assessing patients with suspected lung fibrosis to provide a diagnostic subtype classification, potentially facilitating proper treatments at an earlier stage of the disease process.” He added that the clearance is a phenomenal breakthrough, not just for those suffering from lung fibrosis but also for the development of technologies that deal with AI-based healthcare.

Imvaria concurrently secured CPT billing numbers from the American Medical Association, which was a significant step toward obtaining coverage and compensation. This was done in conjunction with the agency’s clearance.

Reicher highlighted the emergence of a feasible and cost-effective option for the medical community and health insurance companies. He emphasized that this development makes artificial intelligence highly practical, beneficial, and easily integrable into medical practices, particularly benefiting the numerous pulmonologists dedicated to treating patients with lung disease.

The Fibresolve classifier, which is powered by machine learning, had previously been given groundbreaking designation by the FDA. The technology classifies probable instances of interstitial lung disease (ILD) by analyzing data from computed tomography (CT) scans of the lungs. By utilizing ML pattern recognition to provide a diagnostic classification output derived from imaging data, it improves upon the conventional care method. 

The early usage of Fibresolve was able to reduce the frequency of lung biopsies throughout a health system by over 40%, as stated in prior corporate research. Additionally, it was able to cut costs by guiding individuals who need therapy the most to the expensive fibrosis medicines that are available today.

Imvaria made the announcement around the end of last year that it had inked a deal with the Mayo Clinic to build artificial intelligence algorithms for the purpose of studying instances of lung cancer. The engineers working for the company will utilize the extensive health data archives maintained by the clinic. Imvaria was initially introduced to the public in 2019, at which time it was released by a group of programmers from Google and Stanford University.