Teleflex, a US-based firm that provides medical devices for critical care and surgery, has won US FDA 510(k) clearance for its Arrow NextStep retrograde femoral length dialysis catheter. The catheter adds to the company's existing ...
Tags: Teleflex, Dialysis Catheters
St. Jude Medical, a medical device manufacturer, has received US Food and Drug Administration (FDA) approval for its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac ...
Tags: St.Jude, SJM Assura Devices
France-based specialty diagnostic solutions provider Diaxonhit and XDx in the US, have entered into a memorandum of agreement (MoU) for the exclusive license to market and perform AlloMap Molecular Expression Testing (AlloMap) in Europe. ...
Tags: Diaxonhit Partners, Market Allomap
The US Food & Drug Administration (FDA) has issued a tentative approval letter to Supernus Pharmaceuticals for its Trokendi XR (extended release topiramate) in the treatment of epilepsy. Following to completion of review of the Trokendi ...
Tags: Supernus Trokendi, FDA Approval
Respitek, a South Africa-based disposable medical devices maker, has received the US Food and Administration (FDA) clearance for the Bobbi Baby Shield, which is meant to shield against infection post Hypospadias repair surgery. Meant for ...
Tags: Respitek, Bobbi Baby Shield
The U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) is proposing new requirements for labeling beef products that have been mechanically tenderized, including adding new cooking instructions, so that ...
Integrity Applications, an Israel-based medical device company, has received CE Mark approval for its GlucoTrack DF-F non-invasive device. The GlucoTrack DF-F is a glucose measuring device that uses a patented combination of ultrasound, ...
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
German-based Bayer has bought majority stake in Conceptus, a birth control manufacturer, and expects the purchase of the entire Californian firm for $1.1bn to close soon. According to Bayer, over 96% of the company's outstanding shares ...
Tags: birth control, Bayer
The Over-the-Top trunk rack uses a “clearance frame” to reach over a car’s spoiler on so-called “no fit” SUVs, minivans and hatchbacks previously not compatible with trunk racks due to potential spoiler damage. ...
Tags: Transportation, Hollywood Racks, Trunk Rack
Saying that its reorganized management structure is in place and that it is making progress in its turnaround plan, Quiksilver still has much work in front of it as it reported a loss of $32,385,000 for the second quatter ended Apr.30 this ...
Tags: Quiksilver, Sporting Goods
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
JoS. A. Bank Clothiers, Inc. announces that net income for the first quarter of fiscal year 2013 was $8.1 million as compared with net income of $14.8 million for the first quarter of fiscal year 2012. Diluted earnings for the first ...
Tags: Clothiers Reports, Apparel
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
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 ...