Day: February 2, 2018

U.S. regulators approved a second gene therapy for a blood cancer, a one-time, custom-made treatment for aggressive lymphoma in adults, a report released to the press said recently. The US Food and Drug Administration (FDA) allowed sales of the treatment from Kite Pharma. It uses the same technology, called CAR-T, as the first gene therapy approved in the U.S. in August, a treatment for childhood leukemia from Novartis Pharmaceuticals. "In just several decades, gene therapy has gone from being a…

Boston Scientific Corporation announced positive results from the WHISPER randomized controlled trial (RCT). The data, presented at the 2018 Annual Meeting of the North American Neuromodulation Society in Las Vegas, demonstrated that patients who are given the choice to use both sub-perception and paresthesia-based spinal cord stimulation (SCS) therapy achieve superior outcomes in comparison to patients who have only one SCS therapeutic option. SCS works by sending low electrical pulses, which vary in frequency, pulse width and amplitude, to the…

BD (Becton, Dickinson and Company), a leading global medical technology company, along with Check-Points Health B.V., announced that the companies obtained CE Mark for a next-generation molecular screening test for antibiotic-resistant carbapenemase-producing organisms (CPOs) on the fully-automated BD MAX™ System. It is estimated by the year 2050, as many as 10 million people could die annually from antimicrobial resistance (AMR) if no action is taken. AMR is the ability of a microorganism (such as a bacteria) to survive despite being…

Abbott announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for the Quadra Assura MP™ Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Fortify Assura™ Implantable Cardioverter Defibrillator (ICD), two of the company's most widely-used high voltage medical devices. The approvals follow recent MR-conditional labeling approvals for the Assurity MRI™ pacemaker, Ellipse™ ICD and associated MRI-compatible leads, and further expand Abbott's portfolio of MRI-ready devices for patients indicated for ICDs and/or CRT-D devices who may need an MRI…