A study in the UK demonstrated significant improvements in HbA1c for users of automated insulin delivery technologies. This comes on the heels of a UK NHS initiative to provide tens of thousands of children and adults with type 1 diabetes in the country with an artificial pancreas. The study aimed to assess the efficacy of […]
Clinical Trials
Neuronoff hits first-in-human milestone for Injectrode neuromod
Neuronoff announced today that it completed the first-in-human clinical trial evaluating its flagship Injectrode neuromodulation product. The Cleveland-based company designed Injectrode to treat chronic pain. The LIFE (lumbar Injectrode feasibility evaluation) trial evaluated Injectrode’s safety and effectiveness, meeting all goals, the company said. Injectrode placement comes through an 18-gauge needle (no incisions) under local analgesia […]
Thermedical completes feasibility study to use SERF with PFA
Thermedical announced today that it completed a feasibility study using pulsed field ablation in combination with its SERF ablation system. Weston, Massachusetts–based Thermedical designed its SERF system and Durablate catheter to work with PFA to treat ventricular tachycardia (VT). According to Thermedical, SERF (saline-enhanced radio frequency) ablation provides a new, more efficient form of biological […]
Hyalex Orthopaedics announces first cases with synthetic knee cartilage implant
Hyalex Orthopaedics announced today that patients successfully received knee implants as part of its first-in-human clinical trials. The procedures came as part of two prospective, studies for the Hyalex Knee Cartilage System in the U.S. and Europe. Sites for both studies already enrolled and treated patients with the synthetic cartilage technology. The technology has FDA […]
Concept Medical enrolls first patient in drug-coated balloon study
Concept Medical announced today that it commenced the FDA investigational device exemption (IDE) study of its MagicTouch system. MagicTouch, a sirolimus drug-coated balloon (DCB), treats in-stent restenosis (ISR) in coronary artery disease (CAD). Dr. Said Ashraf enrolled the first patient in the MAGICAL-ISR study at the AtlantiCare Institute in Atlantic City, New Jersey. The balloon […]
CroíValve is set to challenge as tricuspid regurgitation treatment space heats up
With Edwards and Abbott making recent waves in the tricuspid regurgitation (TR) treatment space, CroíValve hopes to pave its own way. Edwards’ Evoque valve became the first transcatheter therapy to receive FDA approval to treat TR in February. This month, Abbott became the second with its TriClip transcatheter edge-to-edge repair (TEER) system picking up an […]
Noah Medical has positive robotic bronchoscopy data
Noah Medical today announced new field data detailing early experience using its Galaxy system for robotic-navigated bronchoscopy. Dr. D. Kyle Hogarth (University of Chicago Medical Center) and Dr. Amit Mahajan (Inova Fairfax Hospital) provided the field data. It represents the findings from 165 total patient procedures investigating 190 total lesions. Key findings include diagnostic yield […]
CVRx has more data supporting long-term benefits of Barostim
CVRx (Nasdaq:CVRX) announced the publication of post-market data highlighting long-term, sustained benefits with its Barostim device. Minneapolis-based CVRx published results from the BeAT-HF trial in the European Journal of Heart Failure. Data supported Barostim treatment in heart failure patients with reduced ejection fraction. Barostim delivers electrical pulses to baroreceptors in the wall of the carotid […]
Glucotrack expands CGM tech to spinal epidural space
Glucotrack (Nasdaq:GCTK) announced today that it plans to expand its glucose monitoring technology to measure glucose in the epidural space. Rutherford, New Jersey-based Glucotrack said CGM taking readings in the spinal epidural space could integrate with existing treatments for painful diabetic neuropathy (PDN). Specifically, Glucotrack sees spinal cord stimulation (SCS) technology as a potential integration […]
Cognito Therapeutics has positive non-invasive neuromod results
Cognito Therapeutics today announced treatment results from an open-label extension study of its Alzheimer’s treating neuromodulation system. The Cambridge, Massachusetts-based company’s Spectris system could provide disease-modifying therapy for treating Alzheimer’s disease. Its non-invasive neuromodulation device delivers proprietary gamma frequency light and sound stimulation. This evokes EEG-confirmed gamma frequency brain oscillations to treat central nervous system […]
Paragonix has positive long-term data on heart preservation
Paragonix Technologies today announced positive long-term registry results demonstrating improvements after heart transplantation. Results from the GUARDIAN-Heart registry demonstrated statistically significant improvements in 2-year survival following heart transplantation. The analysis consisted of a total of 1,261 U.S. adult patients matched using statistical propensity matching. This created two cohorts of equal baseline characteristics to compare the […]