Oculus Innovative Sciences has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its new Microcyn scar management HydroGel, intended to manage old and new hypertrophic and keloid scarring resulting from burns, ...
US-based TYRX has obtained an approval from the US Food and Drug Administration (FDA) for expanded indications in marketing the AIGISRx N antibacterial envelope for use with spinal cord neuromodulators. Recently, TYRX has also obtained an ...
Lowering CT dose and improving workflow are not choices that clinicians should have to make, so Toshiba CT is putting customers first by providing the industry's best solutions to solve these challenges. To make complex exams easier, ...
US-based BioMedical Enterprises (BME) has obtained the US Food and Drug Administration (FDA) clearance (K131640) for its upgraded HammerLock Nitinol intramedullary fixation system for hammertoe deformities. The patent-pending HammerLock ...
Aerocrine, a medical products company, has announced that Japanese health authorities have approved the use of its FeNO-measuring device NIOX MINO as a tool for assessing patients with airway inflammation such as asthma. On 19 November ...
US-based Illumina has obtained premarket clearance from the US Food and Drug Administration (FDA) for the MiSeqDx system, a high-throughput DNA sequencing analyzer. The company has also obtained premarket clearance from the FDA for the ...
Tags: Illumina, MiSeqDx System
Boston Scientific, a medical device company, has obtained the US Food and Drug Administration clearance and CE Mark approval for its Direxion torqueable microcatheter, designed to facilitate selective access and delivery of diagnostic, ...
Tags: Boston Scientific, Microcatheter
US-based NeuroPace has received the US Food and Drug Administration (FDA) premarket approval for its NeuroPace RNS system, designed to treat partial onset seizures that have not been controlled with two or more antiepileptic medications in ...
Tags: RNS System, NeuroPace
Discovery Laboratories, a specialty biotechnology company dedicated to advancing a new standard of respiratory critical care, has announced that the US Food and Drug Administration (FDA) has cleared the company's investigational new drug ...
Tags: Discovery Labs, Medicine
Topera, a US-based medical device company, has announced the US Food and Drug Administration (FDA) 510(k) approval and commercial availability of its FIRMap catheter and RhythmView 3D mapping workstation. For clinicians, the RhythmView 3D ...
Tags: Topera, clinician, firmap catheter, FDA approval
OrSense, a developer of solutions for non-invasive measurements of various blood parameters, announced that it has received the US Food and Drug Administration clearance for its NBM-200MP, noninvasive hemoglobin (Hb) and pulse oximetry ...
Tags: Orsense, FDA Clearance
LabStyle Innovations, the developer of Dario, has announced the official European launch date for the Dario iOS mobile application. Dario is a cloud-based, mobile health (mHealth) platform for diabetes and related blood glucose ...
NLT SPINE, a manufacturer of minimally invasive spine surgery products, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its generation 2.0 PROW FUSION and eSPIN lumbar interbody fusion products, which are ...
Tags: Espin Products, Medicine
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
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