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
Ethicon Endo-Surgery, a subsidiary of Johnson & Johnson, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for an expanded indication of ear, nose and throat (ENT) procedures for the ENSEAL tissue sealers. The ...
iTraumaCare, an early-stage medical device firm focused on developing traumatic injury solutions, has achieved its fourth regulatory milestone with an expanded indication for use from the US Food and Drug Administration (FDA). The ...
Maple Leaf Foods has completed the sale of Rothsay, its rendering and biodiesel business, to Darling International of Irving, Texas, for C$645m. Rothsay is a major rendering company in Canada and a producer of biodiesel with six rendering ...
Tags: Maple Leaf, Biodiesel
EndoChoice, a US-based medical device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Fuse gastroscope, which has two cameras and has a 245 degrees field of view. The new gastroscope joins the ...
Tags: Endochoice, Fuse Gastroscope
VIDA Diagnostics, a provider of quantitative imaging and informatics services, has announced the release of Apollo 2.0 at the 2013 American College of Chest Physicians Conference. The software advance signifies the next generation product ...
Tags: VIDA Diagnostics, Chest Physicians
Ethicon Endo-Surgery, a subsidiary of Johnson & Johnson, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for the HARMONIC ACE+ 7 Shears with Advanced Hemostasis (HARMONIC ACE +7). HARMONIC ACE+ 7 is an ...
Lundbeck, a Denmark-based pharmaceutical company, has obtained the US Food and Drug Administration (FDA) approval for its SABRIL (vigabatrin), an adjunctive treatment option for children 10 and older with refractory complex partial ...
US-based Abbott Laboratories has obtained an approval from the US Food and Drug Administration (FDA) for its MitraClip device, designed to treat patients with significant symptomatic degenerative mitral regurgitation (MR) who are at ...
Tags: FDA Approval, Abbott
Kraft Foods has recalled certain varieties of Kraft and Polly-O String Cheese and String Cheese Twists products, as they may spoil, leading to product discoloration, the US Food and Drug Administration (FDA) announced. The products ...
Antares Pharma, a provider of self-injection drug delivery technology, has received a US Patent, entitled 'Prefilled Syringe Jet Injector', which will help in protecting its auto injector technology and product pipeline including the VIBEX ...
Laboratory Corporation of America Holdings (LabCorp) has announced the nationwide availability of QIAGEN’s therascreen KRAS RGQ PCR kit, a new US Food and Drug Administration (FDA) approved companion diagnostic for certain colorectal ...
Tags: Labcorp, Colorectal Cancer
Medical device company LDR Holding has announced the presentation of 48-month safety and efficacy data of both one-level and two-level cervical disc replacement with Mobi-C when compared to anterior cervical discectomy and fusion (ACDF). ...
Tags: Medical device, Mobi-C Study