New FDA-cleared, AI-based tool Fibresolve may help in IPF diagnosis
Software able to recognize subtle patterns of lung scarring on imaging scans
The U.S. Food and Drug Administration (FDA) has approved Fibresolve, an AI or artificial intelligence-based software that’s designed to help — noninvasively — in the diagnosis of idiopathic pulmonary fibrosis (IPF) and other lung diseases marked by fibrosis, or scar tissue buildup.
This marks the first FDA clearance of a diagnostic tool for any type of lung fibrosis, according to Fibresolve’s developer Imvaria.
“For people living with the rapidly deteriorating symptoms of this rare, yet deadly disease, the FDA authorization of Fibresolve offers real hope, while giving doctors who treat these patients a new, powerful tool that is designed to save lives and reduce suffering at an exponential rate that only AI can deliver,” Michael Muelly, MD, co-founder and chief technology officer of Imvaria, said in a company press release.
“This truly is a major step forward in advancing digital healthcare through the use of AI in the hands of medical doctors,” Muelly added.
Along with the FDA clearance, the American Medical Association (AMA) has assigned Fibresolve with current procedural technology or CPT codes — a type of standardized identification code used by clinicians when reporting on their use of medical services and procedures. These universal identifiers are recognized and used by other clinicians who may look at a patient’s records, as well as by health insurance companies for billing purposes.
AI-based software intended to return its results within minutes
A particularly damaging type of lung disease that’s idiopathic, or has no known cause, IPF is characterized by lung inflammation and fibrosis that drive progressive declines in lung function.
Moreover, some tests used to confirm an IPF diagnosis, such as a lung biopsy, are invasive and require anesthesia.
Fibresolve is an AI-based software intended to facilitate the diagnosis of various types of lung fibrosis, especially IPF, using imaging data collected during noninvasive CT scans of the lungs.
Essentially, the algorithm — a type of digital biomarker — has been trained to recognize subtle imaging patterns associated with IPF and other types of lung fibrosis. That allow Fibresolve to predict what disease subtype a person has. According to the company, it learned how to do this by analyzing clinical information from thousands of patients.
Imvaria says Fibresolve can be used as an option to help clinicians reach a diagnosis before resorting to more invasive and time-consuming approaches.
The medical community, along with health insurance companies, now has a viable, cost-effective option making AI highly practical, useful, and easy to incorporate into medical practice for the thousands of pulmonologists who treat patients with lung disease.
The FDA previously granted Fibresolve breakthrough device designation, which is intended to help speed the development of technologies that can help diagnose and treat life-threatening diseases more effectively.
In addition to the substantial health benefits of an earlier diagnosis and treatment, Imvaria believes that Fibresolve could save thousands of dollars per patient.
“The medical community, along with health insurance companies, now has a viable, cost-effective option making AI highly practical, useful, and easy to incorporate into medical practice for the thousands of pulmonologists who treat patients with lung disease,” said Joshua Reicher, MD, co-founder and CEO of Imvaria.
Doctors will order the use of Fibresolve similarly to the way they’d order a lab test when they suspect a person has IPF or a related lung disease, according to Imvaria. A patient’s imaging data would be transmitted to the cloud-based system and run through the algorithm, with results returned within minutes.
Trained doctors should use the data as a diagnostic tool in conjunction with patients’ medical history, symptoms, other diagnostic tests, and their own professional judgment, the company notes.
“It’s important to have new and validated options, such as Fibresolve, for those patients at risk of IPF,” said Joshua Mooney, MD, a pulmonologist and professor at Stanford Medicine, in California. “I look forward to seeing the positive impact of Fibresolve on lung fibrosis patients across the nation.”