EnteroMedics has submitted premarket approval (PMA) application to the US Food and Drug Administration (FDA) for Maestro Rechargeable System's VBLOC, a vagal blocking therapy to treat obesity. Maestro RC system delivers vagal blocking ...
Tags: EnteroMedics, Vbloc Therapy
US medical device company TriVascular has commenced the US Post-Approval Study (PAS) of the Ovation Prime Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA). The Ovation System and the Ovation Prime System ...
Tags: TriVascular, medical device
CryoLife has received premarket approval from the US Food and Drug Administration (FDA) for its new Sologrip, a minimally invasive laser fiber-optic delivery system. The Sologrip delivery system is a single-use, disposable handset ...
The Trellis Bed, part of Universal's new Bellamy girl's bedroom, has a pierced laser-cut overlay in Daisy White with an Antique Rose panel that reverses to French Grey peeking through. HIGH POINT - Universal Furniture is launching ...
Tags: Universal Furniture, Furniture, Furnishing, Bedroom
"The iTrace for Blood Centers device has the ability to enhance blood safety by helping to ensure that unsuitable units are not released," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research. "iTrace ...
Tags: Blood Tracking Device, Health, Medicine
EnteroMedics is planning to submit the pre-PMA (Premarket Approval) application for its Maestro Rechargeable System's VBLOC vagal blocking therapy, based on the ReCharge Pivotal Trial, in the second quarter of 2013. The decision follows ...
Tags: Enteromedics, VBLOC Therapy
Ethicon Endo-Surgery's division Sedasys has received premarket approval (PMA) from the US Food and Drug Administration (FDA) for the first computer-assisted personalized sedation (CAPS) solution, Sedasys System. The system is used for the ...
Tags: Ethicon, Premarket Approval
Cerus' proposed modular premarket approval (PMA) application shell for Intercept Blood System for platelets has been accepted for review by the US Food and Drug Administration (FDA). The PMA application shell accepted by the FDA for the ...
BioControl Medical has gained the US Food and Drug Administration approval to begin the third and largest phase of INOVATE-HF (INcrease Of VAgal TonE in Heart Failure), a global, multi-center, investigational device exemption (IDE) clinical ...
Tags: BioControl Medical, FDA, Medical
Samuel Lawrence Furniture’s well received HomeWork 2.0 introduction includes this patent pending work hutch on dining room table. When not in use, the hutch can be stored on the table stretcher. HIGH POINT — Premarket sponsors ...
Tags: Samuel Lawrence Furniture, patent pending work, company news
Full line importer Coaster plans a big introduction for the second opening of its showroom a Premarket here. The company will have at least three floors of new product to show dealers at its 111 E. Commerce Ave. showroom. Additionally, it ...
Exact Sciences has submitted the second module of premarket application (PMA) of its noninvasive stool DNA colorectal cancer screening test to the US Food and Drug Administration (FDA). The module included the required studies and ...
Tags: FDA, colorectal cancer, clinical trial
Medtronic has completed patient enrollment in controlled, multicenter, prospective IN.PACT SFA II clinical trial of its IN.PACT Admiral drug-eluting balloon device for treating patients with peripheral artery disease in the superficial ...
Tags: drug, Medtronic, eluting balloon study
Dune Medical Devices' MarginProbe system, designed for the detection of breast cancer, has obtained premarket approval (PMA) from the US Food and Drug Administration (FDA). The system is an intra-operative tissue assessment tool which ...
Tags: Dune Medical, FDA Approval, Breast Cancer Detection Device, Medicine
APPLE says it sold more than two million iPhone 5s in China in their first three days of availability, setting a record for that market. The iPhone 5, which launched in China on Friday, will be available in more than 100 countries by the ...
Tags: Apple, Iphones, Computer Products, Consumer Electronics