Quantel Medical has received the U.S. Food and Drug Administration (FDA) approval for its selective laser trabeculoplasty (SLT) glaucoma laser for clinical use, called Solutis. Solutis is a 532nm SLT laser designed for primary open angle ...
Tags: Quantel Medical, Glaucoma Laser
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
The US Food and Drug Administration (FDA) has approved the first rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 antigen in human serum, plasma, and venous or fingerstick whole blood specimens. The Alere ...
Tags: Rapid Diagnostic Test, HIV-1, HIV-2
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
India-based Torrent Pharma’s US subsidiary has announced the recall of the company’s anti-psychotic drug Olanzapine 10mg tablets from the US market due to a packaging issue. Torrent manufactured the drug for Prasco Labs in the ...
Tags: Torrent Pharma, Packaging Issue
Stryker Interventional Spine has received 510(k) clearances from the US Food and Drug Administration (FDA) for Venom RF cannula and electrode combination and11g iVAS balloon system. The Venom RF cannula and electrode combination contains ...
The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee has recommended approval of Bayer’s oral soluble guanylate cyclase (sGC) stimulator, riociguat, in two forms of pulmonary ...
Tags: FDA Advisory Committee
Perrigo Company has received final FDA approval for abbreviated new drug application for generic equivalent to cutivate lotion, 0.05% and begins immediate shipment of the product. Cutivate Lotion 0.05% (fluticasone propionate lotion, ...
The US Food and Drug Administration (FDA) has expanded age indication for Novartis' Menveo (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) to include infants and toddlers aged two months and ...
CryoLife has announced the first European clinical implant of its HeRO (Haemodialysis Reliable Outflow) graft following its CE Mark in June 2013. The procedure was performed at the University of Leuven Hospital in Belgium by Professor ...
Tags: CryoLife, Outflow Graft
The US FDA Nonprescription Drugs Advisory Committee (NDAC) has recommended approval of Sanofi's Nasacort AQ nasal spray (triamcinolone acetonide) for over-the-counter use in the country. Nasacort AQ Nasal Spray is indicated to treat the ...
Tags: Nasacort AQ Nasal Spray, Medicine
US-based BioFire Diagnostics has begun clinical and analytical studies to evaluate its FilmArray Gastrointestinal (GI) Panel. This clinical study is being conducted at several hospital-based clinical laboratories in the US and is funded ...
British drug-maker GlaxoSmithKline (GSK) has reached settlement with the attorneys general of eight US states over misleading marketing of the diabetes treatment drug, Avandia, and even agreed to pay $229m to settle the lawsuits. Without ...
Tags: Avandia Lawsuits, Medicine
Hologic's Aptima HPV assay has received clearance from the US Food and Drug Administration (FDA) for use on its fully-automated Panther system, enabling laboratories to run multiple tests from a single specimen. A nucleic acid amplified ...
Tags: Panther System, Aptima HPV Assay
The US Food and Drug Administration (FDA) has dispatched warning letters to 15 firms, including foreign and domestic to desist from selling their illegally marketed diabetes products. The latest move will help the regulator to curb the ...
Tags: Diabetes'Medicines, active pharma