Artificial Intelligence healthcare developer Viz.ai said this week it won approval from the FDA for its LVO Stroke platform designed to analyze computed tomography results and notify providers of potential strokes, touting it as the first such system to win FDA clearance. The company’s LVO Stroke platform is designed using deep learning and connects to […]
Shares in Pacira Pharmaceuticals (NSDQ:PCRX) fell nearly -16% today after a panel of experts convened by the FDA voted against an expanded use for Pacira’s injectable pain drug. The pharmaceutical company previously submitted an application seeking to use the local anesthetic as a regional pain-killer. Get the full story at our sister site, Drug Delivery Business News.
Banyan Biomarkers this week won FDA clearance for its Banyan Brain Trauma Indicator blood test designed to evaluate concussions in adults, making it the first such test of its kind to get a pass from the federal watchdog. Approval for the device came through the the FDA’s breakthrough devices program and took only six months […]
Stryker (NYSE:SYK) said today it won expanded FDA indications for its Trevo thrombectomy device, now cleared as a front-line treatment for acute ischemic stroke patients for up to 24 hours from symptom onset. The expanded indication lifts the previously cleared treatment window by 18 hours, according to the Kalamazoo, Mich.-based company. “The 24-hour indication opens the […]
Medtronic (NYSE:MDT) touted data today from an at-home pediatric study of its MiniMed 670G hybrid closed-loop diabetes management system. The company’s study included 105 kids, ages 7 to 13, and found that patients spent more time in the target blood glucose range, had less glycemic variability and experienced less hypo- and hyperglycemia compared to baseline data. […]
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its self-expanding transcatheter Centera aortic heart valve, with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized […]
DreaMed Diabetes has won CE Mark clearance for its Advisor Pro decision-support platform, designed to help healthcare professionals manage insulin therapy for their Type I diabetes patients. The company’s cloud-based platform provides personalized insulin treatment plans by combining data from insulin pumps and continuous glucose monitors. Using machine learning techniques, the system analyzes all of the […]
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval for its Impella 2.5 and Impella CP heart pumps, now cleared for use during elective and urgent high risk percutaneous coronary intervention procedures. With the expansion, the Impella heart pump is cleared for use with patients with severe coronary artery disease, complex anatomy and a number […]
TransEnterix (NYSE:TRXC) said today it filed an FDA 510(k) submission looking to expand the indications for its Senhance robotic surgical platform to include laparoscopic inguinal hernia and laparoscopic cholecystectomy surgeries. The Research Triangle Park, N.C.-based company said that with the additional indications, its Senhance system would be cleared for use in the most common abdominal surgeries in […]
The FDA has approved Glooko‘s mobile insulin dosing system, which is designed to titrate long-acting insulin for people with Type II diabetes. The company’s system accesses blood glucose data directly from the user’s glucose meter so that the user doesn’t have to manually enter their fasting glucose values. Then, it analyzes those levels to recommend insulin […]
Sandoz said today that the FDA has approved its Glatopa glatiramer acetate injection as a generic version of Copaxone to treat relapsing forms of multiple sclerosis. The therapy, which is given three days per week, is administered using the Glatopaject injection device. Get the full story at our sister site, Drug Delivery Business News.