Sira Medical has secured the US Food and Drug Administration (FDA) 510(k) approval for its augmented reality (AR) preoperative surgical planning application.
The US-based medical software provider said that its new application will provide clinicians with advanced imaging to help them make key patient management decisions.
According to the company, certain parts of the anatomy are partially or fully hidden on CT scans and MRIs, forcing surgeons to make critical decisions during the surgery, leading to errors.
Sira Medical said that its holograms will allow surgeons to prepare for surgery with more confidence by providing opportunities to reduce patient complications and improve outcomes.
Sira Medical co-founder and CEO Rick Beberman said: “We enable surgeons to manipulate anatomical models, make virtual cuts, and simulate corrections, among other features. Our proprietary image creation process provides anatomical clarity and fidelity.”
Sira Medical is a medical software company engaged in developing augmented reality software for preoperative planning, patient education, and training.
The company provides patient-specific holograms derived from the same data used to generate conventional CT scans and MRIs.
Sira Medical has validated its technology through multiple peer-reviewed studies, in which the AR application reduced operating time and was preferred for surgical planning.
The technology was originally developed at the University of California, San Francisco (UCSF), with funding from the UCSF Innovation Ventures Catalyst program.
Sira Medical has exclusively licensed the technology through the UCSF Office of Technology Management and Advancement and raised funding from 500 Global and Eileses Capital.
Sira Medical co-founder and UCSF pediatric radiologist Jesse Courtier said: “When planning for surgery, surgeons face a recurring challenge in applying radiology information onto real-world patients, because they still rely on 2D images. Our technology eliminates that hurdle, thus improving efficiency and patient safety.”
Eileses Capital managing partner Kishore Bopardikar said: “The $15bn market for CT scans and MRIs is ripe for innovation. By achieving this major milestone and attracting positive reviews from surgeons, we believe Sira Medical is poised to become a leader in the medical imaging sector.”
