Preoperative radiotherapy controls resected brain metastases in phase 2 trial; FDA lets Paradromics open BCI study nationwide

• Research Oct 30, 2026
  Preoperative radiotherapy gives 100% six-month local control of resected brain metastases in 63-patient phase 2 STEP trial
  In the open-label, single-arm, multicenter STEP trial in Neuro-Oncology, adults with up to four brain metastases, including one resectable lesion, received three fractions of stereotactic radiotherapy followed by resection within three days of the last fraction. Of 63 patients who received both, six-month local control was 100% (95% CI 95% to 100%), meeting the primary end point, and no leptomeningeal disease occurred. The one-year incidence of index-lesion radiation necrosis was 7%, 22 patients (35%) had distant intracranial failure and 12-month overall survival was 81.2%. The authors said the results support evaluation in ongoing randomized trials.
  Sources: Neuro-Oncology, PubMed
• FDA Oct 26, 2026
  FDA approves Paradromics protocol change opening Connexus brain-computer interface study to patients nationwide
  Paradromics said Oct. 26 that the Food and Drug Administration (FDA) approved an amendment to its Connect-One early feasibility study, removing the requirement that participants live within a four-hour drive of a participating site. The study, authorized under an investigational device exemption in November 2025, evaluates long-term safety and performance of the implanted Connexus brain-computer interface in people with severe motor impairment, initially to restore communication. The company completed its first long-term human implantation at University of Michigan Health in June 2026.
  Source: Paradromics via BioSpace

The weekly innovation roundup for neurosurgery, published every Sunday for the week before; every item links to its sources. Latest neurosurgery news · All specialties