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 ...
Danish biotechnology company Zealand Pharma and partner, the Swiss pharma group Helsinn have jointly cHelsinn's Phase IIa study with elsiglutide for the prevention of chemotherapy-induced diarrhea in cancer patients has been completed with ...
Tags: Health, Medicine, biotechnology
GE Healthcare has obtained 510(k) clearance from the US Food and Administration (FDA) for its Brivo Plus C-arm, which is made available now in the US. The approval is expected to transform healthcare in private practices and rural ...
Tags: Healthcare, Health&Medicine, FDA
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