Shares in Collagen Solutions (LON:COS) rose this week after the U.K.-based company touted positive data from an eight-year study of 15 patients who received ChondroMimetic implants to repair cartilage defects in their knees. The company plans to apply for CE Mark clearance in the European Union for its ChrondroMimetic implant based on the results from […]
Clinical Trials
Senseonics’ implantable glucose monitor succeeds in 90-day trial
A 90-day trial involving patients with Type I and Type II diabetes showed that Senseonics‘ (NYSE:SENS) implantable continuous glucose monitor was safe and accurate compared to reference glucose values, according to a study published in Diabetes Technology & Therapeutics. The single-arm study enrolled 90 participants and implanted them with Senseonics’ Eversense device, which sends glucose data every […]
Italian court convicts Boston Scientific employee in criminal case
A court in Italy levied more than $1 million in fines and penalties against Boston Scientific (NYSE:BSX) and other defendants after finding one of its employees guilty in a criminal case there, the company said today in a regulatory filing. The Court of Modena, Italy, ordered a trial back in February 2015 against Boston Scientific, a […]
Study: Abbott’s Nanostim leadless pacers solid at 3 years outside battery redesign issues
Abbott‘s (NYSE:ABT) Nanostim leadless pacemaker was found to be safe and effective after three years, outside of a battery-related malfunction that required a redesign, according to study data reported by Healio. Data came from the first-in-human Leadless study and was published in a research letter in the journal Circulation, according to the report. A single patient […]
Smith & Nephew touts results from Allevyn Life adhesive dressing hip fracture trial
Smith & Nephew (NYSE:SNN) today released the results from a trial of its Allevyn Life multi-layer silicone adhesive foam dressing, touting that its addition to standard care protocols reduces the onset of pressure ulcers by 71% in elderly patients being treated for hip fracture. The trial was published in the International Wound Journal, the London-based company […]
Medtronic looks to expand MiniMed 670G into pediatric diabetes
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. […]
GSK seeks expanded label for Trelegy Ellipta inhaler in EU
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data to the European Medicines Agency in the hopes of expanding the label for its once-daily, triple combination inhaler, Trelegy Ellipta. The drug-device combo was approved in Europe in November last year as a maintenance treatment for adult patients with moderate to severe chronic obstructive pulmonary disease who are not adequately […]
Orthofix launches RCStim rotator cuff repair trial
Orthofix (NSDQ:OFIX) said today it launched a study looking to evaluate the use of pulsed electromagnetic field technology with the company’s RCStim device as adjunctive treatment to the surgical repair of rotator cuff tears. The 538-patient study, which has begun enrollment, will evaluate the safety and effectiveness of PEMF technology designed to promote bone growth and […]
Relievant touts 1-year Intracept trial results
Relievant Medsystems today released the results from the Smart trial of its Intracept intraosseous nerve ablation system exploring its usefulness at treating chronic lower back pain, touting significant decreases in pain from baseline at three months. The Intracept system is designed to use radio frequency energy delivered through specially designed instruments during a minimally invasive surgical […]
Avita wins expanded FDA compassionate use for ReCell device
Avita Medical (ASX:AVH) said today the FDA approved an expansion to the number of patients treatable by its ReCell device under the compassionate use investigational device exemption program by 20 individuals. The ReCell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and […]
Pulmatrix doses first patient in Ph1 Pulmazole trial
Pulmatrix (NSDQ:PULM) said today that the first patient was treated in a first-in-human study of Pulmazole – an inhaled formulation of the anti-fungal drug, itraconazole. The Lexington, Mass.-based company is evaluating its iSperse formulation of the drug as a treatment for asthma patients who have developed allergic bronchopulmonary aspergillosis. Get the full story at our sister […]