CyMedica Orthopedics said it has launched a clinical trial to evaluate the effectiveness of its E-vive muscle-strengthening device and patient engagement system in knee osteoarthritis patients. Researchers will combine the data generated by the E-vive neuromuscular electrical stimulation device with the activity and health data collected by commercially available wearable smartwatch devices to determine the effect […]
Clinical Trials
Senseonics touts strong safety profile in long-term Eversense CGM post-market registry
Senseonics (NYSE:SENS) said yesterday that is presenting long-term safety data on its Eversense CGM from a European post-market clinical follow up registry later this week, touting that results showed the device as having a strong safety profile. The presentation is slated to take place this Saturday as part of the American Diabetes Association’s Scientific Sessions in […]
BrainBox wins FDA breakthrough nod for TBI test, launches pivotal trial
Brain-injury diagnostic dev BrainBox Solutions said today that the FDA granted it a breakthrough device designation for its in-development BrainBox Traumatic Brain Injury test and that it launched a pivotal trial of the system. The Richmond, Va.-based company’s BrainBox TBI test is a multi-modality, quantitative test combining injury-related blood protein biomarkers with computerized neurological assessments. […]
Sequana Medical lands IDE approval for abdominal pump trial
Sequana Medical said it has received investigational device exemption approval from the FDA to conduct a pivotal study of its Alfapump device for patients with recurrent or refractory ascites due to liver cirrhosis. Alfapump is a fully implantable pump designed to continuously remove excess abdominal fluid in patients with liver disease. Zurich-based Sequana has applied to […]
Windtree, Eleison tout feasibility study results
Windtree Therapeutics (OTCQB:WINT) and Eleison Pharmaceuticals have announced positive results of a feasibility study using Windtree’s aerosol delivery system (ADS) to deliver Eleison’s inhaled lipid cisplatin (ILC) for lung cancer. In the study, the ADS technology produced in 20 minutes approximately the same volume of aerosolized ILC that required approximately two hours to produce in a phase 2 […]
Bluegrass Vascular’s pivotal Surfacer trial meets primary endpoints
Bluegrass Vascular Technologies today released preliminary results from the pivotal trial of its Surface Inside-Out access catheter system, touting that the trial met both its primary and secondary endpoints. The San Antonio-based company also said that it has completed enrollment in the SAVE-US trial, recruiting 30 patients across seven U.S.-based centers. “I’m quite encouraged by […]
Saluda Medical touts Evoke closed-loop SCS studies
Saluda Medical today released data from two studies of its Evoke ECAP-controlled closed-loop spinal cord stimulator. The Evoke SCS system is designed to measure the spinal cord’s response to stimulation and adjust on every pulse to maintain activation within the patient’s therapeutic window, the Australian company said. Results from both the Evoke and Avalon studies […]
Ancora Heart launches 2nd AccuCinch ventricular repair system feasibility study
Ancora Heart said yesterday that it launched a U.S.-based early feasibility study looking to evaluate its AccuCinch ventricular repair system intended for treating patients with reduce ejection fraction systolic heart failure. The first patient has already been enrolled in the study at UPMC Pinnacle Harrisburg by Dr. Hemal Gada and Dr. Mubashir Mumtaz, Santa Clara, […]
NuVasive touts submission of spine registry data to CMS
NuVasive Inc. (NSDQ:NUVA) said yesterday that it submitted its SpineTrack registry quality performance data to the Centers of Medicare & Medicaid Services. The data was submitted on behalf of healthcare providers at Southern Oregon Neurosurgical & Spine Associates (SONSA) for CMS’s merit-based incentive payment system, the San Diego-based company said. As a result of the submittal, […]
Philips touts Stellarex drug-coated balloon data
Patients using Royal Philips’s (NYSE:PHG) Stellarex drug-coated balloon maintained blood flow through the treated segment of diseased arteries at three years in a pair of clinical trials. Stellarex is designed to restore and maintain blood flow in the superficial femoral artery and peripheral arteries. It’s coated using the company’s EnduraCoat technology to elute the drug paclitaxel. Spectranetics won […]
Checkpoint Surgical touts nerve monitor study results
Checkpoint Surgical today announced the results of a study that called its handheld nerve monitor a safe and reliable alternative to existing technology for neural monitoring during surgery. The retrospective study compared the use of the Cleveland, Ohio-based company’s Checkpoint nerve stimulator/locator to Medtronic’s nerve integrity monitor for vagal, recurrent and superior laryngeal nerve monitoring […]