Procept BioRobotics (Nasdaq:PRCT) announced today that the FDA approved an investigational device exemption (IDE) trial for its Aquablation therapy. The WATER IV PCa trial will compare Aquablation to radical prostatectomy. Procept expects the study to enroll up to 280 men with Grade Group 1 to 3 localized prostate cancer. It takes place across 50 centers, […]
Clinical Trials
Precision Neuroscience has more positive BCI data
Precision Neuroscience today announced the presentation of results from a pilot study of its brain-computer interface (BCI) technology. Researchers from the lab of Dr. Iahn Cajigas presented results at the Society for Neuroscience (SfN) Neuroscience 2024 conference in Chicago. Cajigas serves as a neurosurgeon at Penn Medicine and an assistant professor of neurosurgery and bioengineering […]
Paragonix expands liver transplant registry
Paragonix today announced a significant expansion of its GUARDIAN-Liver clinical registry with the appointment of a new principal investigator. The Waltham, Massachusetts-based organ transplant technology developer — which Getinge acquired for $477 million last month — now has more than 500 enrollments in its clinical registry for its liver preservation and transport technologies. With this […]
SetPoint Medical gets FDA IDE to study neurostimulation for MS
SetPoint Medical today announced FDA Investigational Device Exemption approval to study its proprietary neuroimmune modulation platform for people with relapsing-remitting multiple sclerosis. Valencia, California–based SetPoint plans to initiate a multicenter, randomized, double-blind, sham-controlled pilot study in 2025. The plan is to enroll 60 people across the United States. “We look forward to initiating this pilot […]
Conformal Medical kicks off left atrial appendage occlusion device trial
Conformal Medical announced the initiation of a study assessing intracardiac echocardiography (ICE) imaging appendage closure procedures. The GLACE study looks at ICE imaging of the left atrial appendage (LAA) during closure devices with the next-generation CLAAS AcuForm device. It evaluates this combination in patients with non-valvular AFib. Conformal Medical plans for the study to enroll […]
Synchron reports positive results from Command study of its BCI system
Brain-computer interface (BCI) developer Synchron today said there were no serious adverse events in its 12-month Command study, which also showed reliable performance of the Stentrode implant. Synchron won FDA breakthrough device designation for the endovascular brain implant in 2020. The Command study is the first investigational device exemption (IDE) trial of a permanently implanted […]
InBrain Neuroelectronics announces first-in-human BCI procedure
InBrain Neuroelectronics today announced the first human procedure using its cortical brain-computer interface (BCI) technology. The procedure took place at Salford Royal Hospital, part of the Northern Care Alliance NHS Foundation Trust in Manchester, U.K. Dr. David Coope, a neurosurgeon and chief clinical investigator, led the study with Kostas Kostarelos, the chief scientific investigator and […]
Orthofix to showcase new pulsed electromagnetic field stimulation tech
Orthofix today announced plans to present new data supporting the use of its proprietary pulsed electromagnetic field (PEMF) stimulation. Lewisville, Texas-based Orthofix is evaluating PEMF stimulation to increase fusion rates as an adjunct to lumbar spine fusion surgery. Patients treated with the SpinalStim bone growth therapy demonstrated a high rate of successful fusion, according to […]
AngioDynamics kicks off study of thrombectomy system for pulmonary embolism
AngioDynamics (Nasdaq:ANGO) announced today that it launched a new trial evaluating its AlphaVac F18 system in treating pulmonary embolism (PE). The prospective, multicenter, multi-national, single-arm trial evaluates the AlphaVac F18 multipurpose mechanical aspiration system. It looks at the efficacy, safety and long-term functional outcomes of using it to perform percutaneous mechanical aspiration thrombectomy. RECOVER-AV aims […]
Jupiter Endovascular announces first cases with Vertex pulmonary embolectomy system
Jupiter Endovascular today announced the first two patients treated in a study of its Vertex pulmonary embolectomy system. Investigators treated two patients in the SPIRARE I study of the Vertex system using the company’s Endoportal Control platform technology. Dr. Grzegorz Kopec, Dr. Jakub Stepniewski, and Dr. Krzysztof Bartus performed the successful cases. They took place […]
Onward reports third brain-computer interface implant
Onward Medical today announced the third successful implant of its ARC-BCI brain-computer interface offering to restore mobility. Eindhoven, the Netherlands–based Onward designed ARC-BCI to restore lower limb mobility after spinal cord injury (SCI). The BCI offering combines the ARC-IM stimulator implant with the WImagine BCI from CEA-Clinatec. Onward reported the first human implant of the […]
