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
The Ninth Circuit Court of Appeals has denied the Food and Drug Administration’s (FDA) appeal to delay the upcoming food safety regulations. As per the court ruling, the agency will have time till 20 December to publish draft ...
Tags: Food Safety regulations
Covalon Technologies has granted exclusive rights to Molnlycke Heath Care to exploit Covalon's antimicrobial silicone adhesive technology in the field of single-use surgical, wound care and vascular access medical dressings. Pursuant to ...
Tags: Covalon, Silicone Adhesive
FzioMed, a medical device company, has received approval from the commissioner of the US Food and Drug Administration (FDA) of its petition for an independent review of its premarket approval application (PMA) for Oxiplex Gel. Oxiplex is ...
Tags: FzioMed, Oxiplex Gel
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 ...
Denmark-based medical device company Novo Nordisk has obtained the US Food and Drug Administration (FDA) approval for its NovoLog (insulin aspart [rDNA origin] injection) FlexTouch and Levemir (insulin detemir [rDNA origin] injection) ...
The US Food and Drug Administration (FDA) has approved Roche's new drug Gazyva (obinutuzumab) in combination with chlorambucil chemotherapy for treatment of patients with chronic lymphocytic leukemia (CLL) who have not previously been ...
Tags: Combination Vaccine, Medicine
Cochlear, a provider of implantable hearing solutions, has announced that the Cochlear Nucleus 6 sound processor is now available as an upgrade for Nucleus Freedom implant system (CI24RE) and Nucleus 5 implant system (CI422 and CI500 ...
Tags: Cochlear, Recipients
Advanced Medical Isotope (AMIC), a developer of medical isotopes, has filed 510(k) pre-market notification to the US Food and Drug Administration (FDA) approval for its Yttrium-90 RadioGel brachytherapy cancer product. In accordance to ...
US-based Pentax Medical initiated a voluntary nationwide recall of 76 PENTAX gas/ water valves, model OF-B194 on 16 September 2013. The valves were offered as a separate purchase for use with PENTAX GI video endoscopes (90i/90k series and ...
Tags: Pentax Medical, Water Valve
US-based medical device company Vycor Medical has announced the issuance of a new patent in Australia for its NovaVision vision restoration technology. The new Australian patent is for visual testing methods that fixate the user's gaze ...
Tags: Vycor Medical, medical device
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
Germany-based Raumedic has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its NEUROVENT-PTO device, a multimodal catheter for monitoring brain tissue oxygen partial pressure, intracranial pressure (ICP), and ...
Tags: Raumedic, Neurovent-PTO Device
Janssen-Cilag (Janssen), a subsidiary of Johnson & Johnson pharmaceutical firm, has submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) for the approval of once daily oral drug ibrutinib for the ...
Tags: Blood Cancer Medicine, Medicine
Puratos introduces Cremfil Ultim, fillings that offer the bakery and patisserie industry an answer to consumer demands for indulgence, health and convenience – the three aspects that have been driving growth in snacking over recent ...
Tags: bakery, patisserie industry