Mauna Kea Technologies has received 510(k) clearance from the US Food and Drug Administration (FDA) for its AQ-Flex 19 miniprobe. AQ-Flex 19 miniprobe is used to provide real-time optical biopsies during endoscopic ultrasound-guided fine ...
GlaxoSmithKline (GSK) has submitted a new drug application (NDA) to the US FDA for umeclidinium bromide (UMEC) monotherapy 62.5mcg to treat chronic obstructive pulmonary disease (COPD). The investigational once-daily UMEC, administered ...
Tags: GlaxoSmithKline, FDA Approval, chronic obstructive pulmonary disease
NinePoint Medical has received an additional 510(k) clearance from the US Food and Drug Administration (FDA) for its NvisionVLE Imaging System. The approval will expand the system's indication to include imaging of esophageal tissue ...
Sorin Group has received an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence a clinical study of its PERCEVAL S sutureless aortic tissue valve. The bioprosthetic valve is designed ...
Medical technology provider Integra LifeSciences has introduced Integra Compact Cranial Closure System that provides titanium implants for non-loadbearing (non-facial) operative cranial neurosurgical procedures. Featuring a small and ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Spine Wave's intervertebral body fusion device. Producing expandable PEEK spacers, the StaXx IB system will now for the first time offer an expandable device with ...
Tags: FDA, Spine Wave
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Teleflex's ARROW VPS G4 device. Used in conjunction with the accompanying disposable ARROW VPS Stylet, the device uses micro-Doppler ultrasound technology along ...
Tags: FDA, ARROW VPS G4 Device
The US Food and Drug Administration (FDA) is set to investigate the safety of foods that contain caffeine and their effects on health of children and adolescents. This move comes after Wrigley introduced a caffeinated gum called Alert ...
Tags: FDA, Safety of Caffeine
ConAgra Foods is voluntarily recalling approximately 14,000 cases of its Orville Redenbacher’s Classic Kettle Korn flavored ready-to-eat popcorn as they may contain milk that is not mentioned on the product label. The recall was ...
Tags: ConAgra Foods, Popcorn
Last fall I flew halfway across the country to go grocery shopping with Everly Macario. We set out from her second-story apartment in Hyde Park near the University of Chicago and walked to the supermarket to buy a couple of?rib?steaks?that ...
Tags: Agriculture, Food
A decades-long push to require the labeling of foods containing genetically modified ingredients in the United States received a significant boost Wednesday [Apr. 24, 2013], when bipartisan bills on the issue were simultaneously proposed ...
Distributors of children's products are cautioned to dot their compliance "i's" and cross their regulatory "t's," especially if they are selling online. According to a leading consumer product safety attorney, the government has taken to ...
Sanofi Pasteur and KaloBios Pharmaceuticals have announced the issuance of FDA fast track designation for novel biologic candidate KB001A targetting Pseudomonas Aeruginosa (Pa). An antibody fragment KB001A is developed against Pa that ...
Tags: Sanofi Pasteur, KB001A
Spinal implants and instruments manufacturer Southern Spine has launched StabiLink MIS Spinal Fixation System. The FDA-approved and CE-marked minimally invasive system provides spinal fixation in lumbar fusion procedures, including the ...
Vycor Medical has obtained two new patents for its Spinal ViewSite Cervical Access System (VCAS). The patents, including 2008-518369 and 11/993280, are for the US and Japan and cover an introducer and retractor system for use in spinal ...