Julian’s Recipe is voluntarily recalling European Style Pretzel Baguette packages from HEB Stores in Texas, US, over allergy concerns. According to the company, certain packages of Pretzel Baguettes may contain Julian's European ...
The US Food and Drug Administration (FDA) is evaluating the safety of Intuitive Surgical's robotic surgical devices. Currently, the agency is studying a small group of surgeons who use the surgical device, which is used in over 2,000 ...
Cook Medical has received the 510(k) approval from the US Food and Drug Administration (FDA) for its Evolution Biliary Controlled-Release Uncovered Stent. Adding to the Cook's line of Evolution controlled-release stents for the ...
Tags: Cook Medical, Biliary Stent
Blue Belt, next generation surgical orthopedic instruments developer, has received 510(k) approval from the US Food and Drug Administration (FDA) to market its Stride Unicondylar Knee implant system. With the clearance, the Stride implant ...
Tags: Blue Belt, FDA Approval
Medtronic has received both the US Food and Drug Administration (FDA) approval and the CE (Conformité Européenne) Mark clearance for its Pacific Plus percutaneous transluminal angioplasty (PTA), the new peripheral balloon ...
Tags: Angioplasty Balloon, Medicine
US-based establishment Finger Lakes Farmstead Cheese is recalling 12 wheels of Gouda cheese, as it may be contaminated with Listeria monocytogenes Type 1, according to the US Food and Drug Administration (FDA). The product associated with ...
Tags: cheese, Agriculture, Food
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's Tafinlar (dabrafenib) and Mekinist (trametinib) as single-agent therapies for unresectable or metastatic melanoma with BRAF V600E mutation. Tafinlar is not indicated ...
Astellas Pharma and Medivation have announced the Health Canada approval of Xtandi (enzalutamide) capsules to treat metastatic castration-resistant prostate cancer. The oral, once-daily androgen receptor inhibitor is indicated for ...
Tags: Astellas Pharma, Medicine
US-based spine technology company Spinal Elements have licensed a portfolio of patents necessary for accessing the lumbar spine from a lateral approach and placing implants from that approach. The lateral approach to the spine offer ...
Lightlife Foods, in cooperation with the US Food and Drug Administration (FDA), has issued a nationwide recall of Market Veggie Burgers as they may contain an undeclared allergen - milk. According to the company, certain packages of the ...
Tags: Lightlife Foods, Allergy Risk
Patient monitoring and respiratory care devices provider Covidien's Nellcor Pulse Oximeters has obtained 510(k) clearance with labeling from US Food and Drug Administration (FDA). Nellcor Pulse Oximeters facilitates in noninvasive ...
Tags: Covidien's Nellcor, Medicine
Traumatic injury medical devices developer iTraumaCare has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its iTClamp Hemorrhage Control System. iTClamp is designed to control severe bleeding, in seconds, and ...
Tags: Itraumacare, FDA Approval
The US Food and Drug Administration (FDA) has given its approval for the marketing of Roche's Cobas Integra 800 Tina-quant HbA1cDx assay for the diagnosis of diabetes. Presently available in the market, the HbA1c tests, or A1c tests are ...
Tags: Diabetes Diagnosis, Medicine
Glenmark Generics, a subsidiary of Glenmark Pharmaceuticals, is recalling several lots of Gabapentin, Pravastatin, and Topiramate drugs from across the US markets primarily due to “odd smell.” The US Food and Drug ...
Tags: Glenmark Generics, Drugs
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Varian Medical's diagnostic X-ray image processing workstation that integrates radiography/fluoroscopy (RF) and digital radiography (DR) capabilities. The company's ...
Tags: X-ray Image, Medicine