US- based St. Jude Medical has acquired Endosense, a Switzerland-based company for a purchase price of $170m (CHF159m) up-front plus the potential for up to $161m (CHF150m) in subsequent milestone payments. While the acquisition is ...
The US Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel is scheduled to decide on Ocular Therapeutix’s premarket approval application for the ReSure Sealant in September and may suggest some recommendations. ...
Tags: Ophthalmic Devices, Health
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 ...
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
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
Angel Medical Systems, a developer of continuous intracardiac ischemia monitoring technologies, has raised $27.5m in the financing round. In the round, Angel's existing venture capital, strategic partner and investors, as well as a ...
Tags: clinical trial, financing round, clinical technology, investment
Aptus Endosystems, a developer of endovascular aneurysm repair (EVAR) technology, has completed $25m series BB equity financing. Aptus will use the finance to expand commercialization of its HeliFX Aortic Securement system in the US and ...
Tags: Aptus Endosystems, endovascular aneurysm repair technology
Cartiva, a developer of orthopedic implants, has completed enrolling patients in its MOTION trial. The prospective, multi-center trial, which has enrolled 233 patients across Canada and the UK, is designed to assess the company's ...
Tags: Cartiva, clinical trial, clinical technology
Endosense, a provider of cardiac technologies, has completed enrolling patients in its Toccastar clinical study. The prospective, randomized, multi-center investigational device exemption trial, which enrolled 300 patients with ...
Tags: Endosense, Toccastar clinical study, cardiac technologies