Actuated Medical, a US-based medical device company, has obtained the additional US Food and Drug Administration (FDA) approval for its TubeClear system. The company has added several new clearing stem models for the TubeClear system and ...
Tags: Actuated Medical, medical device
Bayer HealthCare Pharmaceuticals, a subsidiary of Bayer, has obtained two separate orphan drug designations from the US Food and Drug Administration's (FDA) Office of Orphan Products Development for its investigational, oral medication ...
Tags: Drug Designations, Medicine
Purdue Pharma has obtained approval from the US Food and Drug Administration (FDA) for the launch of a new 15mcg/hr dosage strength of Butrans (buprenorphine) Transdermal System CIII. Following the approval, Butrans will be available in ...
Tags: Pain Drug, Purdue Pharma
Medtronic, a US-based manufacturer of implantable heart-rhythm devices, has obtained the US Food and Drug Administration (FDA) approval for the Complete SE (self-expanding) vascular stent for use in superficial femoral artery (SFA) and ...
Tags: Medtronic, Lower Extremities
Luminex, a biotechnology company, has obtained the US Food and Drug Administration (FDA) and European approvals for a new personalized medicine genotyping assay, xTAG CYP2C19 kit. xTAG CYP2C19 kit is a comprehensive genotyping assay that ...
Tags: Genotyping Assay, Luminex
Solana Surgical, an extremity orthopedic products company, has introduced its FuseFORCE SuperElastic fixation system, designed for orthopedic and podiatric surgeons’ use in fusing the small joints in the foot and ankle, and hand and ...
Tags: Solana Surgical, Fixation System
The US Food and Drug Administration (FDA) has issued final guidance on how it will handle regulation of medical apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical ...
Tags: Mobile Medical Apps
Medical imaging technology company Toshiba America Medical Systems has announced that it will launch its Aquilion large bore CT system at American Society of Radiation Oncology annual meeting in Atlanta. The US Food and Drug ...
The US Food and Drug Administration (FDA) has finalized a new rule for the unique device identification (UDI) system, designed to provide a consistent and clear way to identify medical devices. The FDA worked jointly with industry, ...
Tags: Unique Device, Medicine
US-based LabStyle Innovations has obtained CE Mark approval for its Dario smartphone-based glucose monitor and comprehensive diabetes management system. Particularly useful for insulin-dependent patients, the system provides patients, ...
US-based Sapheon has submitted the first module of pre-market approval (PMA) application to the US Food and Drug Administration (FDA) for its VenaSeal sapheon closure system, designed to treat venous reflux (varicose veins) disease. This ...
Tags: PMA Application, Medicine
The US Food and Drug Administration’s (FDA) Ophthalmic Devices Panel announced that Ocular Therapeutix’s ReSure sealant is safe and effective in managing clear corneal wound leaks following cataract surgery. ReSure Sealant is ...
Tags: Ocular Therapeutix, Medicine
Greiner Packaging International has announced its decision to avoid using the chemical compound Bisphenol A (BPA) in the production of food packaging. By the end of March 2014, the company plans to replace all production lines with ...
Tags: Food Packaging, Raw Materials
Greiner Packaging International has outlined plans to ban the use of chemical compound Bisphenol A (BPA) in the production of food packaging by the end of March 2014. The company plans to change all production lines to 'BPA-free' raw ...
Tags: Food Packaging, Food
Medical device company Teleflex has introduced ARROW JACC (jugular axillo-subclavian central catheter), a small-french size antimicrobial and antithrombogenic catheter designed for both acute and long-term use, with Chlorag+ard technology. ...