The U.S. Food and Drug Administration has allowed marketing of the Cerena Transcranial Magnetic Stimulator, a device to relieve pain caused by migraines. Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for ...
U.S. allergists say a new long-term medication in under-the-tongue tablet form is promising and may even have the potential to cure hay fever. Officials at the American Academy of Allergy, Asthma & Immunology said allergy immunotherapy is ...
The U.S. Food and Drug Administration approved the first generic versions of Cymbalta, a drug used to treat depression and other conditions, officials say. Dr. Kathleen Uhl, acting director of the Office of Generic Drugs in the FDA's ...
Duke University’s Duke Clinical Research Institute (DCRI) has been selected by Oxygen Biotherapeutics, a pharmaceutical company, to conduct the Phase III clinical trial of the company’s newly acquired compound, levosimendan. ...
Ethicon Endo-Surgery has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its HARMONIC FOCUS+ shears with adaptive tissue technology. HARMONIC FOCUS+ now brings adaptive tissue technology to open procedures ...
Tags: Ethicon, HARMONIC FOCUS+, adaptive tissue, technology, HARMONIC
BSD Medical, a provider of medical systems, has signed an agreement with Active Medical for the sales and distribution of the MicroThermX Microwave Ablation line of products. Pursuant to the agreement, BSD recently commenced shipment of ...
Tags: BSD Medical, Active Medical, agreement, distribution agreement
W. L. Gore & Associates (Gore) has obtained the US Food and Drug Administration (FDA) approval for its GORE VIABAHN endoprosthesis for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous ...
Tags: Gore, FDA, GORE VIABAHN, endoprosthesis, AV access
The US Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favorably by a majority that the benefits of the Boston Scientific's WATCHMAN left atrial appendage closure device ...
Tags: FDA, Boston Scientific, WATCHMAN, left atrial appendage closure device
Watson-Marlow Pumps Group is introducing a new food grade hose for use with Bredel pumps. FDA and EC compliant, the new F-NBR hoses offer better wear resistance and longer life for improved production efficiency and process/product safety. ...
Tags: Pump Hoses, Industrial Equipment, Components
Dow Corning’s proven Dow Corning 3074 Intermediate – used extensively as a reliable, high-performance material of choice in the demanding architectural, marine and industrial sectors – is now available for food-contact ...
Baxter International has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for the approval of a recombinant antihemophilic porcine sequence factor VIII called 'OBI-1' for the treatment of patients ...
The U.S. Food and Drug Administration has released the final version of a voluntary plan to phase out the use of certain antibiotics in food animals. Antibiotics are added to the feed or drinking water of cattle, hogs, poultry and other ...
Tags: Agriculture, Food
A "misfire" is the way Eric Topol, MD, describes 23andMe's recent regulatory tussle with the FDA, which resulted in the Silicon Valley-based company halting sales for now of its health-related genetic test analysis. Speaking with MPMN ...
Tags: 23andme, FDA, regulatory tussle
U.S. regulators are working hard to keep up with the rapidly evolving digital health care sector, according to William Maisel, chief scientist of the FDA's Center for Devices and Radiological Health. Speaking last week during BIOMEDevice ...
Tags: FDA, Grapples, Digital Health
The largest medical device companies have had a good run on the stock markets this year, with many clocking in double-digit percentage growth in stock prices over the past 12 months. There are always exceptions to the rule, however. Here ...
Tags: Medical Device, Medical Device Firms, Worst Performing Firms