Elon Musk announced that his Neuralink brain-computer interface (BCI) venture completed its first-in-human implant this week. The entrepreneur posted on X (formerly Twitter) to confirm the implant, which took place on Jan. 28. “The first human received an implant from Neuralink yesterday and is recovering well,” Musk posted. “Initial results show promising neuron spike detection.” […]
Clinical Trials
CroíValve wins FDA IDE for tricuspid heart valve
CroíValve announced today that it began an early feasibility study for its Duo tricuspid coaptation valve system. The beginning of the study follows FDA investigational device (IDE) approval. Tandem II, a prospective, multi-center, non-randomized, single-arm study looks at the safety and performance of Duo in patients with severe or greater symptomatic tricuspid regurgitation (TR). Duo […]
Microbot Medical expands U.S. operations to prep for first in-human clinical study
Microbot Medical, the developer of the Liberty endovascular robotic surgical system, is building on the momentum from the positive results of its good laboratory practices (GLP) pre-clinical study. The company is adding a clinical research associate to support its pending investigational device exemption, or IDE, submission to commence its first-in-human clinical trial. The clinical research […]
Cognito Therapeutics enrolls first patient in sensory neurostim biomarker study
Cognito Therapeutics announced today that it enrolled the first patient in a biomarker study within its HOPE pivotal trial. HOPE evaluates a novel disease-modifying therapy that elicits gamma-frequency brain activity through non-invasive sensory stimulation. Cambridge, Massachusetts-based Cognito aims to slow the progression of Alzheimer’s disease from the comfort of a patient’s home. This evaluation looks […]
Boston Scientific has positive spinal cord stimulation data
Boston Scientific announced positive one-year results from a trial evaluating its spinal cord stimulation (SCS) technology. The SOLIS randomized control trial demonstrated sustained pain relief with the WaveWriter Alpha SCS system for treating non-surgical back pain (NSBP). Boston Scientific presented data at the 2024 North American Neuromodulation Society (NANS) meeting in Las Vegas. Dr. James […]
Axogen has positive nerve implant data
Axogen (Nasdaq:AXGN) announced positive topline results from a clinical study evaluating its Axoguard Nerve Cap. The REPOSE study compares standard-of-care neurectomy of symptomatic neuroma to neurectomy and protection of the terminated nerve end with the Axoguard Nerve Cap. Axoguard Nerve Cap is a proprietary surgical implant. Derived from porcine submucosal extracellular matrix remodeled during healing, […]
Medtronic has positive spinal cord stimulation data
Medtronic today announced data from two clinical trials supporting its spinal cord stimulation (SCS) technologies. The medtech giant shared data at the North American Neuromodulation Society (NANS) annual meeting in Las Vegas. Results demonstrated the benefits of SCS in patients with chronic low back pain (CLBP) and leg pain. The company also plans to highlight […]
Onward begins neurostim study to address post-spinal cord injury hemodynamic instability
Onward Medical announced today that it began the HemON NL clinical feasibility study to evaluate its ARC-IM neurostimulation therapy. Onward said that, in late 2023, a study participant received the investigational ARC-IM neurostimulator and lead implant. This study aims to assess the safety and effectiveness of the therapy to address hemodynamic instability after spinal cord […]
Abbott announces first procedures with Volt pulsed field ablation system
Abbott today announced the first global procedures conducted with its new Volt pulsed field ablation system. Volt treats patients battling common abnormal heart rhythms like AFib. It marks Abbott’s entry into the crowded pulsed field ablation (PFA) space alongside companies like Medtronic, Boston Scientific and Johnson & Johnson’s Biosense Webster. Last month, Medtronic became the […]
FastWave Medical kicks off first-in-human study of its IVL tech
FastWave Medical announced the successful completion of enrollment for its first-in-human study of its peripheral intravascular lithotripsy (IVL) system to treat calcified cardiovascular disease. Dr. Miguel Montero-Baker of Houston Methodist Hospital and the Hope Vascular & Podiatry Clinic and Dr. Venkatesh Ramaiah of HonorHealth Vascular Group and the Pulse Cardiovascular Institute successfully conducted the procedures […]
Gore enrolls first patients in expandable stent graft trial
W.L. Gore & Associates announced today that it enrolled the first patients in a trial evaluating its Viabahn VBX stent graft. The study compares Gore’s balloon-expandable endoprosthesis to bare metal stenting for patients with complex iliac occlusive disease. It aims to inform practice guidelines around the best modalities suited for patients with this condition. Dr. […]