The US Food and Drug Administration (FDA) has granted 510(k) clearance to Surefire Medical's new line of Angiographic catheters. Angiographic Catheter line features a large inner lumen of 0.054 inches which enables interventional ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Zynex's InWave device, designed for treating female urinary incontinence. Following the approval, the company said the InWave device will be manufactured, ...
Tags: FDA, female urinary incontinence, clinical application, clinical product
GeNO has obtained a clearance for its inhaled nitric oxide (NO) delivery system, GeNOsyl MV-1000, from the US Food and Drug Administration (FDA). GeNOsyl MV-1000 system, which incorporates a primary delivery system, a backup system, ...
Tags: FDA, inhaled nitric oxide delivery system, clinical product, GeNO
US based NuPathe announced that its New Drug Application (NDA) resubmission for its migraine patch (NP101) has been accepted for filing by the US Food and Drug Administration (FDA). Migraine Patch (NP101 or Zelrix) is an active, ...
Tags: FDA, NuPathe, migraine patch, NDA
The US Food and Drug Administration (FDA) has granted regulatory approval to Actavis' Diltiazem Hydrochloride (HCL) extended-release capsules. Actavis' Diltiazem HCL capsules are generic equivalent of Valeant's cardiovascular drug, ...
Tags: FDA, Actavis generic, cardiovascular drug
The US Food and Drug Administration (FDA) has approved labeling changes for the Stryker Wingspan Stent System, including the indications for use. The changes were outlined by FDA in a safety communication and specify a more limited group ...
Nanosphere has obtained the US Food and Drug Administration's (FDA) 510(k) approval for its infectious C difficile test, designed for use on the sample-to-result Verigene system. By automating the steps of bacterial DNA extraction, ...
Tags: Nanosphere, difficile test, verigene system, health
US food manufacturer Lancaster Colony has recorded an increase in first-quarter profits on the back of higher prices and lower input costs within its speciality food unit. In the three months to the end of September, net income climbed ...
Tags: Lancaster Colony, Q1, first-quarter profits, higher prices
A recall of US food manufacturer Sunland's peanut butter - which is believed to be contaminated with salmonella - has expanded further. In an announcement at the weekend, the US Food and Drug Administration said Sunland has extended its ...
Tags: recall, Sunland, peanut butter, announcement
US food group Michael Foods has booked an increase in third-quarter profits on the back of higher sales and lower finance costs. The company, which manufactures a range of egg lines, refrigerated potato items and dairy products, posted ...
Tags: Michael Foods, third-quarter profits, higher sales, lower finance costs
Indian pharmaceutical company Sun Pharmaceutical’s US-based subsidiary Caraco is set to resume operations at its manufacturing facility and packaging sites in Detriot and Wixom, Michigan after receiving approval from American health ...
Tags: Caraco, resume operations, manufacturing facility, packaging sites, US
US food giant General Mills said today (27 June) the steepest rise in input costs it has experienced in over 30 years weighed on its full-year earnings. For the 12 months ended 27 May, net profit slid 12.8% to US$1.57bn. Operating ...
Convenience food group Greencore has reported a rise in third-quarter sales, boosted by growth across its business. The company today (31 July) posted a 6.7% increase in underlying sales for the 13 weeks to 29 June. The 6.7% "core ...
Tags: Greencore, sales, underlying sales, company news
US canned food firm Seneca Foods has announced it could buy local peer Independent Foods. Seneca Foods said it had signed an MOU "contemplating an acquisition" of the company, which makes branded and own-label canned fruit. Any deal ...
Tags: Seneca Foods, canned food, Independent Foods
US food retailer Roundy's Inc has cut its full-year profits guidance after seeing weak consumer confidence lead to worse-than-expected sales in its fiscal first-half. For the 26 weeks to the end of June,Roundy's net sales rose by ...
Tags: Roundy's Inc, full-year profits, weak consumer confidence