The US Food and Drug Administration (FDA) has approved Roche's new COBAS TaqMan HIV-1 viral load test. The HIV viral load test utilizes the FDA-approved high pure system viral nucleic acid kit for manual specimen preparation and the COBAS ...
Tags: HIV-1 viral load test, COBAS TaqMan, FDA
NuVasive has gained premarket approval (PMA) for its cervical motion preserving system from the US Food and Drug Administration (FDA). The PCM cervical disc device, which is comprised of superior and inferior endplates, is designed for ...
Tags: cervical motion preserving system, PCM cervical disc device, FDA
Aptalis Pharmaceutical Technologies announced that the European Commission has approved the marketing authorization of new oral granule formulation of Gilead Sciences' Viread, covering 27 countries of the European Union. Viread is ...
Tags: oral granule formulation, Pharmaceutical Technologies, Pharmaceutical
Isis Pharmaceuticals has obtained the US FDA fast track designation for ISIS-TTR to treat familial amyloid polyneuropathy (FAP). The antisense drug ISIS-TTR, a part of the Isis-GSK strategic RNA therapeutic alliance, is being developed ...
Tags: amyloid polyneuropathy candidate, Pharmaceuticals, genetic disease, drug
Roche's Accu-Chek Combo system has been cleared by the US Food and Drug Administration (FDA) for insulin pump therapy. The Accu-Chek Combo system features an insulin cartridge that can hold up to 315 units of insulin, as well as a ...
Pfizer and Ligand Pharmaceuticals have announced the FDA acceptance of bazedoxifene/conjugated estrogens (BZA/CE) new drug application (NDA) for review. The BZA/CE is an investigational therapy developed by Wyeth Pharmaceuticals to tackle ...
Tags: estrogens NDA, Pharmaceuticals, FDA, menopausal symptoms
Simplex Healthcare has entered into collaboration agreement to provide PositiveID's iglucose system, designed for diabetes management. Under the agreement, Simplex will purchase iglucose units and will start trialing the iglucose ...
Tags: Diabetes Management System, clinical application, Simplex
The US Food and Drug Administration (FDA) has approved Abbott's Healon EndoCoat ophthalmic viscosurgical device (OVD). The Healon EndoCoat OVD is a clear, viscous, protective gel intended for use as a surgical aid in cataract ...
Tags: FDA, clinical product, ophthalmic viscosurgical device
The US Food and Drug Administration (FDA) has approved pSivida's investigational new drug (IND) application for injectable sustained-release micro-insert, designed as a treatment for posterior uveitis. pSivida's injectable ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Vitacon's VitaScan LT USB bladder scanner, designed for measuring bladder volume in real-time which avoids the placement of indwelling urethral catheters, a major ...
Tags: bladder scanner, FDA, clinical device
The US Food and Drug Administration (FDA) has granted 510(k) clearance to NovaBay Pharmaceuticals' NeutroPhase skin and wound cleanser for use in moistening and debriding graft and donor sites. The approval allows the company to use ...
Tags: FDA, wound cleanser, clinical application
Globus Medical has obtained premarket approval (PMA) from the US Food and Drug (FDA) for its articulating intervertebral disc replacement device, designed for patients with intractable symptomatic cervical disc disease (SCDD) between ...
Tags: FDA, articulating intervertebral disc replacement device
Life Technologies has introduced a new real-time PCR based molecular diagnostic instrument for diagnostic use in the Europe. The Applied Biosystems QuantStudio Dx instrument, which is released with Quidel Molecular assay for C. difficile, ...
Tags: molecular diagnostic instrument, diagnostic instrument, real-time PCR
The US Food and Drug Administration (FDA) has granted 510(k) approval to Kinetic Concepts for new indication use of vacuum assisted closure (VAC) therapy system. The new indication for VAC therapy for closed incision management will ...
IncellDx has entered into an agreement with BioReference Laboratories to conduct a 10,000 sample study called Slique, designed to compare slideless and liquid-based Pap smears. OncoTect 3Dx, which uses a proprietary flow cytometry-based ...
Tags: liquid-based Pap smear, OncoTect 3Dx, FDA