Machine vision systems supplier Cognex has unveiled a new version of the In-Sight Track & Trace identification and data verification solution for healthcare serialization. The latest version is a follow-up to deployments of In-Sight Track ...
Medtronic has enrolled the first patients in a blinded, controlled, multicenter, parallel arm SubQStim II study of its peripheral nerve stimulation (PNS). Delivered to patients using the company's neurostimulation system, PNS is designed ...
The USFDA has accepted Otsuka Pharmaceutical's new drug application (NDA) of tolvaptan for priority review to treat autosomal dominant polycystic kidney disease (ADPKD). The filing was based on Phase III clinical trial results of the drug ...
Tags: Otsuka Tolvaptan NDA, Medicine
Lupin Pharmaceuticals has obtained final marketing approval from FDA for its Daysee tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP, 0.15mg/0.03mg and Ethinyl Estradiol Tablets, USP, 0.01mg). The company commenced the shipment ...
Pfizer has received breakthrough therapy designation from the United States Food and Drug Administration (FDA) for its investigational compound Palbociclib, a potential treatment for patients with breast cancer. The breakthrough therapy ...
Tags: Cancer Drug, Pfizer, Therapy Designation
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Teleflex's ISO-Gard Mask with ClearAir technology. The ISO-Gard Mask is designed to reduce waste anesthetic gas (WAG), exhaled by the patients who are recovering in ...
Tags: FDA, Drug, Anesthetic Gas
The US Food and Drug Administration (FDA) has cleared Sophono's Alpha 2 magnetic implant system for use with magnetic resonance imaging (MRI). The clearance allows US patients implanted with Sophono Alpha 2 abutment-free, bone conduction ...
Tags: FDA, Drug, magnetic implant system
Olympus has gained 510(k) clearance from the US Food and Drug Administration (FDA) for its Articulating HD 3D laparoscopic surgical video system. The system, ENDOEYE FLEX 3D, when compared with conventional 2D surgical systems reduces ...
Tags: Olympus, FDA Nod, Flex 3D System
The Food and Drug Administration (FDA) has approved Duchesnay USA's Diclegis delayed-release tablet for the treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management. The FDA granted ...
Tags: FDA, Duchesnayusa's Diclegis
Japan-based Shionogi has opted for Qumas ComplianceSP on Microsoft SharePoint 2010 to manage and control quality and manufacturing document. Shionogi will use the Qumas technology for users across the clinical and quality assurance areas ...
Tags: Shionogi, Qumas Compliancesp, Quality Content Management
Newman Labelling Systems, a supplier of pharmaceutical labeling systems, is all set to display its S150 fully automatic labelling system at Total Processing & Packaging Exhibition to be held from 4 to 6 June 2013 in NEC, UK. The S150 has ...
Tags: Packaging, Printing, Display Automatic Labelling System
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Monteris Medical's NeuroBlate system for the treatment of brain tumors and other lesions. The MRI system embedded in the device provides visualization and allows ...
Chindex Medical and Medvio have entered into a collaboration agreement with an advanced imaging and radiation therapy technologies provider iCAD. Under the agreement, Chindex will distribute iCAD's Xoft Axxent Electronic Brachytherapy ...
Tags: Medvio, Chindex Medical, Medicine
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Terumo BCT's automated blood collection system, designed for collecting and storing platelets in Isoplate platelet additive solution (PAS). The solution, which ...
Australian-based SUDA has entered into a definitive agreement to buy NovaDel Pharma's NovaMist technology and certain other assets. The transaction, as contemplated, does not include intellectual property or licenses of NovaDel's ...
Tags: SUDA, Novadel Pharma Novamist