Medical robotics developer Noah Medical announces U.S. FDA clearance of its Galaxy System, which is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
The majority of potentially cancerous lesions are located in the outer third of the lung, which is more difficult for doctors to reach for biopsy. Current technologies are limited in their ability to both reach and then precisely target these suspect lesions, according to the company. However. the Galaxy System’s advanced imaging technologies provide real-time location updates, and are designed to improve tool-in-lesion and diagnostic yield.
“While various technologies to diagnose lung cancer have been utilized over time, the diagnostic yield has remained relatively low,” says Jian Zhang, PhD, Noah Medical founder and CEO. “The Galaxy System is designed to close this gap in the market, giving clinicians a safe and easy-to-use platform to potentially improve diagnostic yield and produce better clinical outcomes. With this FDA clearance, we are excited to move into the commercial phase of our journey.”
The Galaxy System features TiLT+ Technology with integrated tomosynthesis and augmented fluoroscopy. With its always-on-camera bronchoscope, direct visualization is enabled for the entire procedure, including at the time of biopsy.
With purpose-built 4-way bronchoscope articulation, navigation to even the most peripheral lesions is possible. The Galaxy System features a single-use, disposable bronchoscope, intentionally designed to improve efficiency and workflow plus potentially reduce the risk of cross-contamination, the company says.