Sam Brusco, Associate Editor09.08.22
Serpex Medical has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Compass Steerable Needles, steerable biopsy needles for precise access to lung nodules in the intrapulmonary area.
The company aims to leverage steerable instruments to improve lung cancer diagnosis and treatment.
"The Compass steerable needle is a much-needed innovation," interventional pulmonologist Dr. George Cheng told the press. "It provides exceptional maneuverability that will enable us to more precisely target and access lesions, at a nominal cost. It's also agnostic in design, so it can be paired with any navigation platform. It is just what we needed."
The slim, articulating Compass Steerable Needles offer precise 3D positions to enhance reach to all 18 lung segments and access to small lesions outside of the airways. The device provides a controlled approach to target locations and can sample from multiple aspects of the tumor without tip deflection.
"Precision is essential for confidence in diagnosing lung cancer, especially out in the lung periphery," said Sasha Schrode, president and CEO of Serpex. "We are excited to deliver another innovative product that empowers clinicians to more successfully diagnose lung cancer at an earlier stage."
"This is another significant milestone in the team's pursuit of practical, intuitive innovation," added Duke Rohlen, Executive Chairman of Serpex Medical and CEO of Ajax Health and Zeus Health, two backers of Serpex. "Now with two sets of clearances, Serpex is poised to make a significant impact on the standard of care for patients with lung cancer."
The company aims to leverage steerable instruments to improve lung cancer diagnosis and treatment.
"The Compass steerable needle is a much-needed innovation," interventional pulmonologist Dr. George Cheng told the press. "It provides exceptional maneuverability that will enable us to more precisely target and access lesions, at a nominal cost. It's also agnostic in design, so it can be paired with any navigation platform. It is just what we needed."
The slim, articulating Compass Steerable Needles offer precise 3D positions to enhance reach to all 18 lung segments and access to small lesions outside of the airways. The device provides a controlled approach to target locations and can sample from multiple aspects of the tumor without tip deflection.
"Precision is essential for confidence in diagnosing lung cancer, especially out in the lung periphery," said Sasha Schrode, president and CEO of Serpex. "We are excited to deliver another innovative product that empowers clinicians to more successfully diagnose lung cancer at an earlier stage."
"This is another significant milestone in the team's pursuit of practical, intuitive innovation," added Duke Rohlen, Executive Chairman of Serpex Medical and CEO of Ajax Health and Zeus Health, two backers of Serpex. "Now with two sets of clearances, Serpex is poised to make a significant impact on the standard of care for patients with lung cancer."