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
US-based biopharmaceutical company Galena Biopharma has launched the Abstral (fentanyl) sublingual tablets in the US for the treatment of breakthrough cancer pain. The sublingual (under the tongue) fentanyl tablet has been designed for ...
Tags: Sublingual Tablets, Medicine
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 ...
The US Food and Drug Administration (FDA) has approved US-based StemCells’ investigational new drug (IND) application for clinical testing of its HuCNS-SC human neural stem cells as a treatment for spinal cord injury. StemCells is ...
Tags: Spinal Cord Injury, Medicine
Beckman Coulter, a manufacturer of biomedical laboratory instruments, has obtained the 510(k) approval from the US Food and Drug Administration (FDA) for its Access AccuTnI+3 troponin I assay for use on the UniCel DxI series of immunoassay ...
Tags: Beckman Coulter, Cardiac Disease
The US Food & Drug Administration (cof Orphan Product Development has granted orphan drug designation for Lumena Pharmaceuticals' LUM001 clinical program. Lumena obtained orphan designation for LUM001 in four rare cholestatic liver ...
Tags: Orphan Drug, Rare Liver Diseases
The US Food and Drug Administration (FDA) has granted more than $3.5m to various pediatric device consortia to encourage the development and availability of medical devices for children. This grants program is administered by the FDA's ...
Tags: Pediatric Medical Device, Medicine