Danish pharmaceutical firm Novo Nordisk has received biologics licence application (BLA) approval from the US Food and Drug Administration (FDA) for its recombinant coagulation factor VIII, Novoeight. Novoeight is intended for adults and ...
Tags: Novo Nordisk, Drug
US-based Heart Imaging Technologies (Heart IT) has announced the launch of OsiriX interface for the WebPAX image management system. OsiriX is an open-source software package for advanced post-processing of medical images and is the latest ...
US-based Caldera Medical will launch its Desara Mini, Desara Blue, and Desara SL solutions, designed for the treatment of stress urinary incontinence (SUI). The company has already received approval from the US Food and Drug ...
Johnson & Johnson (NYSE: JNJ) announced today that Mark B. McClellan, M.D., Ph.D., Senior Fellow in Economic Studies, and Director of the Initiative on Value and Innovation in Health Care, Brookings Institution, will join the Board of ...
Tags: Light Industry, Daily Use, Johnson
US-based Samsung Electronics America has announced the launch of its Samsung UGEO PT60A, a tablet-based ultrasound system designed to satisfy all applications in the point-of-care market. The Samsung UGEO PT60A includes a full 10.1 inch ...
US-based medical device company Moximed has announced the successful completion of 500th worldwide implant of its KineSpring system, intended to provide a new treatment option for patients with mild-to-moderate knee osteoarthritis. The ...
Tags: Kinespring System, medical device
US-based biopharmaceutical company MannKind has resubmitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking marketing authorization for its AFREZZA inhalation powder, indicated to improve glycemic control ...
Tags: Insulin Application, biopharmaceutical company MannKind
The US Food and Drug Administration (FDA) has approved Antares Pharma's (Antares) OTREXUP, a single-dose, disposable auto-injector for the subcutaneous (SC) once-weekly administration of methotrexate (MTX). OTREXUP is reportedly the first ...
St. Jude Medical, a global medical device company, has completed the acquisition of Nanostim, a developer of miniaturized, leadless pacemakers. St. Jude Medical and Nanostim have entered into a series of agreements in May 2011, pursuant ...
Tags: St.Jude Medical, medical device
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