Genentech, a member of the Roche Group, has announced that the US Food and Drug Administration (FDA) has accepted and filed the company's supplemental biologics license application (sBLA) for subcutaneous use of Xolair (omalizumab) in ...
Ireland-based Crospon has obtained an approval from the US Food and Drug Administration for its EsoFLIP balloon dilation catheter. The device allows measurements of lumen diameter to be made electrically and it eliminates the patient's ...
Integra LifeSciences, an integrated medical technology company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Integra laminoplasty system, a comprehensive set of implants and instruments designed for ...
Sotera Wireless, a medical device company, has obtained an approval from the US Food and Drug Administration (FDA) for its continuous non-invasive blood pressure (cNIBP) technology, a new feature of the ViSi Mobile wireless patient ...
Tags: cNIBP Technology, Sotera Wireless
US-based Maquet Medical Systems has obtained 510(k) approval from the US Food and Drug Administration (FDA) for the VOLISTA surgical lighting system. Incorporating Maquet Medical Systems' Luminance Management Device (LMD) technology, the ...
Tags: Surgical Lighting System
Neuros Medical, a US-based neurostimulation company, has obtained an investigational device exemption (IDE) clearance from the US Food and Drug Administration (FDA) to initiate a randomized, controlled pivotal clinical trial to evaluate the ...
Tags: Neuros Medical, Altius System
In the wake of growing demand by retailers and major food brands, food packaging companies are stepping up their efforts to satisfy customers by seeking Safe Quality Food (SQF) certification. Speaking Tuesday at Pack Expo 2013, Chip Wood, ...
Tags: Packagers, Food Safety, SQF Certification
Bayer HealthCare Pharmaceuticals, a subsidiary of Bayer, has obtained the US Food and Drug Administration (FDA) approval for its Adempas (riociguat) tablets. Adempas tablets are developed for the treatment of adults with ...
Allegro Ophthalmics has received approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to commence two Phase II clinical studies of integrin peptide therapy ALG-1001. The new trials, ...
Tags: Eye Disease Patients
US-based Preventice has obtained CE Mark from the European Commission for its BodyGuardian remote monitoring system for use in detecting and monitoring non-lethal cardiac arrhythmias for ambulatory patients. Preventice has developed the ...
Tags: Remote Monitoring System, Medicine
Germany-based company Brainlab has announced that Mobius Imaging, a US-based company, has received 510(k) approval from the US Food and Drug Administration (FDA) to market the Airo mobile intraoperative CT system in the US. Mobius Imaging ...
Tags: Mobius, Mobile Intraoperative
Advanced Catheter Therapies (ACT), a US-based developer of medical devices, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Occlusion Perfusion Catheter, designed to temporarily occlude a specific region ...
Tags: ACT, Occlusion Perfusion Catheter
The US Food and Drug Administration (FDA) advisory panel has recommended the expanded indication of Medtronic’s cardiac resynchronization therapy-pacemakers and -defibrillators (CRT-P and CRT-D) for the treatment of patients who ...
X-spine Systems, a spinal equipment company, has announced the launch of IRIX-C cervical integrated interbody fusion system, AXLE-X extended angle interspinous fixation system and SILEX sacroiliac joint fusion system. IRIX-C cervical ...
Tags: X-Spine, Spinal Implant Systems
US-based Binder Biomedical has obtained the Food and Drug Administration (FDA) clearance for its Logic, a new anterior lumbar fixation system designed for use in a direct anterior surgical approach for accessing the intervertebral disc ...
Tags: Spinal Fusion Device, Medicine