Sooma Oy secured U.S. FDA investigational device exemption approval to initiate a pivotal study of its transcranial direct current stimulation medical device in people with major depressive disorder. The study will examine the efficacy of the non-invasive Sooma 2Gen device in improving MDD as an at-home treatment.
Medtronic plc reported results from a registry highlighting the effectiveness of the Prevail paclitaxel-coated balloon. The findings from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) were presented by Sacharias von Koch of the department of cardiology and clinical sciences at Lund University, Skåne University Hospital in Sweden at the Cardiovascular Research Technologies 2025 meeting in Washington.
Esophageal cancer, particularly esophageal squamous cell carcinoma (ESCC), is one of the most prevalent digestive malignancies, with a 5-year survival rate of only 20%. Although some cancer immunotherapies based on immune checkpoint inhibitors (ICIs) have shown promise for ESCC, only a minority of patients actually benefit from ICI therapy.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aurora Spine, ICU Medical Lungpacer Medical, Reflow Medical, Skincure Oncology, Smiths Medical.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beckman Coulter, Miach.
Medtronic plc released positive results from a two-year trial of Evolut TAVR that demonstrated superior valve performance in patients with small aortic annuli.