inTRAvent Medical Secures FDA Clearance for Next-Gen SOLOPASS® 2.0 Navigation System

BLUE BELL, Pa.--(BUSINESS WIRE)--inTRAvent Medical Partners LP, a medical device company dedicated to bringing intra-operative imaging and navigation to the bedside to improve neurosurgical procedures, today announced that its next-generation navigation system, SOLOPASS® 2.0, received 510(k) clearance from the U.S. Food & Drug Administration (FDA).

Building upon the foundation established by the original, FDA-cleared SOLOPASS® platform for real-time ultrasound imaging during external ventricular drain (EVD) placement, the latest system offers notable advancements to better serve clinical needs. The updated system features faster processing speeds and a more intuitive workflow, streamlining operation for healthcare providers of all skill levels.

The SOLOPASS® 2.0 system also offers an improved fixation mechanism, designed to make setup simpler and easier. These features, which aim to reduce time and improve accuracy during elective procedures, are particularly valuable in time-sensitive, critical-care environments.

The enhanced SOLOPASS® 2.0 system combines frameless fixation with image guidance for accurate localization and navigation. Unlike other navigation systems that rely on preoperative imaging, SOLOPASS® 2.0 reduces the risk of errors caused by brain shift by providing live anatomical visualization during both elective and emergency procedures. This reduces the risk of complications that can occur in patients with cerebral edema or evolving intracranial pathology.

“Image-guided navigation is common in the OR, but current systems relying on preoperative imaging and complex registration are not conducive to treating emergent bedside cases. SOLOPASS® 2.0 bridges this gap by bringing real-time, accurate navigation directly to the patient’s bedside, which I believe will transform how we manage the treatment of critically ill patients,” said Dr. Kevin Foley, inTRAvent’s Chief Innovation Officer.

“This clearance, combined with our strengthened leadership team, positions us to deliver a transformative bedside navigation solution that raises the standard of care in neuro‑critical settings,” said Adam Barner, inTRAvent’s CEO. “With SOLOPASS® 2.0, we are not only evolving the technology ­– we are elevating patient outcomes and clinician confidence.”

About inTRAvent Medical Partners

inTRAvent Medical Partners is a medical device company dedicated to bringing intra-operative imaging and navigation to the bedside to improve the safety and efficacy of neurosurgical procedures. Its SOLOPASS® platform enables simple, portable neuro-navigation using 2D and 3D ultrasound imaging, artificial intelligence, and trajectory guidance for intra-procedural localization and navigation. For more information, please visit www.inTRAventMedical.com, or find us on LinkedIn.