FDA grants 510(k) clearance to robotic navigated bronchoscope system

The FDA has granted 510(k) clearance to a robotic navigated bronchoscopy system that will aid in diagnosing patients with lung cancer, according to a manufacturer-issued press release.

According to the release, the Galaxy System (Noah Medical) includes several advanced imaging technologies that can give doctors updates on the real-time location of possible cancerous lesions, which mostly reside in the outer third of the lung that is tricky to capture during a biopsy.

Imaging technologies of the system include purpose-built four-way bronchoscope articulation, a bronchoscope camera that is always on, and tool-in-lesion technology with integrated tomosynthesis and augmented fluoroscopy, according to the release.

Another key feature of the Galaxy System noted in the release is that the bronchoscope is made for single-use and is disposable.

“While various technologies to diagnose lung cancer have been utilized over time, the diagnostic yield has remained relatively low,” Jian Zhang, PhD, founder and CEO of Noah Medical, said in the release. “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.”