Respicardia, a US-based implantable therapies developer, has received approval from the US Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) to begin the pivotal trial of remedē System. The trial will ...
Tags: Respicardia, therapies developer
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 ...
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 ...
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
Cerus' proposed modular premarket approval (PMA) application shell for Intercept Blood System for platelets has been accepted for review by the US Food and Drug Administration (FDA). The PMA application shell accepted by the FDA for the ...
Andrew Technologies has obtained 510 (k) clearance from the US Food and Drug Administration (FDA) for its Autologous Fat Transfer device. The liposuction device, which is based on Tissue Liquefaction Technology, reinjects the adipose ...
Ardagh Group and US food processing company HJ Heinz have formed a packaging development partnership to create a 300g jar for the European launch of a new culinary ketchups range. According to the glass products producer Ardagh, the new ...
Tags: Packaging Development, Packaging
InspireMD has received approval for its investigational device exemption (IDE) application from the US Food and Drug Administration (FDA) to initiate MASTER II clinical study of its MGuard embolic protection stent (EPS). The CE-marked ...
Tags: InspireMD, Protection Stent Study
The US Food and Drug Administration (FDA) has approved BD Rx's second injectable antiemetic, BD Simplist Metoclopramide Injection, USP. BD Simplist prefilled injectables are designed to enhance patient care and safety by minimizing the ...
BioFire Diagnostics has submitted 510(k) pre-market notification application to the US Food and Drug Administration (FDA) seeking approval for its FilmArray blood culture identification (BCID) test. The application included positive ...
Tags: Biofire, FDA Clearance
The US Food and Drug Administration (FDA) has approved Warner Chilcott's new oral contraceptive MINASTRIN 24 FE. MINASTRIN 24 FE (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) is indicated for use by ...