NeuroSigma has obtained CE mark approval for its external Trigeminal Nerve Stimulation (eTNS) system, Monarch, designed for the treatment of epilepsy and major depressive disorder in adults and children of 9 years and older. The eTNS ...
Tags: NeuroSigma, eTNS, FDA
CircuLite has obtained CE mark for its new micro-blood pump Synergy Circulatory Support system, designed to treat ambulatory heart failure patients (INTERMACS 4,5,6 / NYHA IIIB and early IV). The Synergy system, which is implanted ...
Guided Therapeutics has obtained CE mark approval for its non-invasive LuViva advanced cervical scan. The approval is based on a US multi-center, pivotal trial, which enrolled 1,607 women at risk for developing cervical disease, to detect ...
Abbott has received CE mark approval for Architect HbA1c assay, designed to monitor treatment efficacy for diabetes patients. The chemiluminescent microparticle Architect HbA1c assay, which is designed for the quantitative determination ...
Tags: Architect HbA1c assay, Architect i immunoassay systems
Stimatix GI, a developer of stomal management solutions, has received CE mark approval for its AOS-C2000 colostomy device. The AOS-C2000 is designed to provide voluntary bowel evacuation and improve the quality of life of people suffering ...
Tags: AOS-C2000 colostomy device, colostomy device, AOS-C1000 colostomy device
NinePoint Medical, a developer of real-time in vivo pathology devices, has obtained CE mark approval for its NvisionVLE Imaging system. The NvisionVLE Imaging system facilitates physicians and pathologists to view real-time volumetric ...
Tags: NinePoint Medical, NvisionVLE Imaging system, optical imaging
Ortho Clinical Diagnostics has received CE mark approval for its new diagnostic blood test, Vitros Immunodiagnostic Product 25-OH Vitamin D Total assay. The Vitros 25-OH Vitamin D Total assay is an one-step immunoassay designed to use on ...
Tags: diagnostic blood test, Vitros Immunodiagnostic Product
Maquet Cardiopulmonary, a unit of Maquet Cardiovascular, has entered into an agreement to purchase Avalon Laboratories' Elite Bi-Caval Dual Lumen Catheter and complimentary vascular access kits for use during extracorporeal life support ...
Tags: Maquet, cardiopulmonary, ECLS
Initial public offering of stock by the loss-making TRIA Beauty postponed due to"ongoing global economic instability". TRIA Beauty,a Californian firm that specializes in hand-held laser diode systems for hair removal,acne treatment and ...
The US Food and Drug Administration (FDA) has granted 510(k) approval to Medigus's SRS endoscopic system. The approval was based on a multi-center clinical trial which met a criteria of safety and efficacy in five countries and three ...
Tags: SRS endoscopic system, endoscopic system, SRS endoscope, the SRS system
True Diagnostics has obtained CE mark approval for its TrueDX Platform and thyroid stimulating hormone (TSH) test. By using a finger prick of blood on TrueDX Platform, doctors can determine if a patient suffers from a hypoactive thyroid. ...
Tags: TSH test, TrueDX Platform and thyroid stimulating hormone test