A new study shows that transcarotid artery revascularization (TCAR) procedures significantly lowered the odds of composite in-hospital stroke, death and heart attack compared to surgical removal of plaque from the carotid artery, according to Silk Road Medical (NSDQ:SILK). The company is developing a neuroprotection and stent system called Enroute as an aid to TCAR procedures. […]
Clinical Trials
HistoSonics touts first-in-human study results
HistoSonics said today that its non-invasive robotics platform and novel sonic beam cancer therapy successfully destroyed 11 tumors in eight patients during its first clinical trial. The results were presented this week at the 2019 Society of Interventional Oncology (SIO) Annual Meeting in Boston. The meeting also included preclinical presentations of what HistoSonics termed promising […]
Dassault Systemes to acquire Medidata for $5.8B
French tech company Dassault Systèmes said today it will purchase health tech firm Medidata Solutions (NSDQ:MDSO) in an all-cash transaction for $5.8 billion on an enterprise value basis or $92.25 per share, slightly lower than yesterday’s closing price of $94.75. The transaction was unanimously approved by the boards of directors of both companies. Dassault Systèmes said the […]
ADA 2019: Hybrid closed-loop devices take center stage
The American Diabetes Association’s 79th Scientific Sessions is a five-day conference where researchers and healthcare professionals share the latest in diabetes research. More than 180 sessions and over 2,000 research presentations took place during the meeting on June 7-11 in San Francisco. During the meeting, diabetes experts shared data and research from clinical trials. Here are four […]
Beta Bionics touts results of bionic pancreas system study
Beta Bionics’ iLet bionic pancreas system significantly increased the percentage of time that adults with Type 1 diabetes spent with glucose levels between 70–180 mg/dl when compared to usual care therapy, according to a new study. The study’s results also suggest that the iLet, using either the Senseonics (NYSE:SENS)Eversense continuous glucose monitoring system (CGM) or […]
Abbott touts real-world CGM data at diabetes conference
Abbott (NYSE:ABT) said today that new data show its FreeStyle Libre continuous glucose monitoring (CGM) system significantly reduces hemoglobin A1c (HbA1c) levels in certain adults with type 2 diabetes. Presented as a late-breaker at American Diabetes Association (ADA) annual conference in San Francisco, the data represent what Abbott termed the first evaluation of real-world evidence from […]
China’s FDA requests small trial of Guided Therapeutic’s LuViva before approval
Guided Therapeutics (OTC:GTHP) said yesterday that China’s FDA has requested a small clinical trial of its LuViva line of cervical scan products. The Norcross, Ga.-based company said it received the request as a “new communication regarding regulatory approval of its LuViva line of products in China,” adding that it plans to submit final paperwork for approval […]
CyMedica launches another trial of muscle-strengthening device
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 […]
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 […]