US-based Binder Biomedical has obtained the Food and Drug Administration (FDA) clearance for its Logic, a new anterior lumbar fixation system designed for use in a direct anterior surgical approach for accessing the intervertebral disc ...
Tags: Spinal Fusion Device, Medicine
InSite Vision Incorporated (INSV) has reported that the US District Court for the District of New Jersey upheld all four of the patents protecting AzaSite, an azithromycin 1% ophthalmic solution, in a patent infringement lawsuit against ...
US-based specialty pharmaceutical firm Par Pharmaceutical has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for clonidine hydrochloride (HCl) extended-release (ER) ...
Tags: Par Pharmaceutical, Medicine
AliveCor, a US-based digital health company, has unveiled its AliveCor heart monitor, a mobile device-based electrocardiogram (ECG) monitor that easily attaches to any supported iOS or Android device. The first FDA-cleared mobile ...
Tags: Mobile ECG Monitor, heart monitor
US-based OrthoSensor has announced its plans to launch its Verasense knee system in European markets after recently receiving CE Mark approval. US-based OrthoSensor has announced its plans to launch its Verasense knee system in European ...
Tags: Verasense Knee System
SuperSonic Imagine, a medical ultrasound company, announced its Aixplorer MultiWave ultrasound system has obtained the US Food and Drug Administration (FDA) approval for the quantification capabilities of its real-time ShearWave ...
Tags: SuperSonic Imagine, Medicine
Medical technology company CareFusion has announced that the US Food and Drug Administration (FDA) classified the company’s voluntary recall of AVEA ventilators as a class I recall. On 3 September 2013, the company initiated the ...
Tags: Medicine Recall
Biotronik, a manufacturer of cardiovascular medical technology, has introduced its Ilesto DX system, which offers the established benefits of the DX System in a thinner and smaller device. This launch follows the approval from the US Food ...
Tags: Biotronik, Ilesto DX System
US-based clinical stage biopharmaceutical firm Heat Biologics has filed an investigational new drug application (NDA) with the US Food and Drug Administration (FDA) for its second product candidate, HS-410, which will be evaluated in ...
Mylan Pharmaceuticals, a subsidiary of Mylan, has introduced Voriconazole for oral suspension, 40 mg/mL, which is the first generic version of Pfizer's VFEND for oral suspension. The US Food and Drug Administration (FDA) has granted a ...
Tags: Mylan, Antifungal Drug
Nucletron, an Elekta Company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for Esteya electronic brachytherapy system, a new approach for high precision skin cancer treatment. Depending on a small, high dose ...
Sequenom, a US-based manufacturer of DNA massarrays, has announced the submission of premarket 510(k) notifications to the US Food and Drug Administration (FDA) for its IMPACT Dx system and the IMPACT Dx Factor V Leiden and Factor II ...
Tags: Impact DX System, Sequenom
Precision Spine, a spinal device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for additional components of its Reform pedicle screw system, designed to treat spinal deformities. The additional ...
Bausch + Lomb, a subsidiary of Valeant Pharmaceuticals International, has obtained marketing clearance from the US Food and Drug Administration (FDA) for its newest frequent replacement silicone hydrogel contact lenses made with ...
Tags: Contact Lens, Medicine
Cornerstone Pharmaceuticals has received the US Food and Drug Administration (FDA) orphan drug designation for its altered energy metabolism directed (AEMD) drug candidate 'CPI-613' for treatment of myelodysplastic syndrome (MDS). MDS is ...