US-based Sapheon has submitted the first module of pre-market approval (PMA) application to the US Food and Drug Administration (FDA) for its VenaSeal sapheon closure system, designed to treat venous reflux (varicose veins) disease. This ...
Tags: PMA Application, Medicine
Ventana Medical Systems,a member of the Roche Group, and pharmaceutical company Boehringer Ingelheim (BI) have entered into a collaboration agreement for the development of companion diagnostic tests for BI oncology programs. Companion ...
The roster of Manufacturing Day 2013 sponsors recently added four more key support organizations, with the Precision Metalforming Association (PMA) and the Association for Manufacturing Technology (AMT) both joining the movement at the ...
Medical device company LDR has received approval from the US Food and Drug Administration (FDA) for commercial sale and distribution of its Mobi-C Cervical Disc (Mobi-C), for two-level indications in the US. The Mobi-C is designed for ...
Tags: Medical device, LDR
HeartWare International has received the U.S. Food and Drug Administration (FDA) approval to enroll supplemental patient cohort for ENDURANCE, a pivotal destination therapy clinical study. HeartWare will enroll up to 286 patients ...
Medtronic has submitted its first pre-market approval (PMA) module to the U.S. Food and Drug Administration (FDA) for the IN.PACT Admiral drug-eluting balloon designed to treat atherosclerotic lesions in the superficial femoral artery ...
Tags: Medtronic, Admiral Drug-Eluting
The US Food and Drug Administration (FDA) has approved Alere's pre-market application (PMA) for the commercialization of Alere Determine HIV 1/2 Ag/Ab Combo in the country. The FDA approval allows the marketing of Alere Determine HIV 1/2 ...
Tags: Alere Determine, Medicine
LDR has received a letter of approval from the US Food and Drug Administration (FDA) for commercial sale and distribution of its Mobi-C Cervical Disc (Mobi-C), for one-level indications in the US. The Mobi-C is designed for cervical disc ...
Tags: Mobi-C Cervical Disc
Computerworld - Starbucks has dropped AT&T as its in-store Wi-Fi provider, teaming up instead with Google and Level 3 Communications to offer 10 times faster network speeds. The coffee shop chain said the changeover will start in August ...
Tags: Starbucks, Wireless Charging
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
Intel has joined The Alliance for Wireless Power (A4WP), an industry group that hopes its "flexible wireless power" specification for mobile wireless charging can become an industry standard. Founded by Qualcomm and Samsung, A4WP claims ...
Tags: Intel, Wireless Power
Powermat Technologies has announced an agreement to merge with its European counterpart, PowerKiss, in a deal that will make what once was two disparate wireless power specifications come together under one. The two companies will come ...
Tags: Powermat, Computer Products, Powerkiss
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