Oticon Medical, a manufacturer of bone anchored hearing systems, has obtained 510(k) approval the US Food and Drug Administration (FDA) to market its Ponto Plus bone anchored sound processors in regular version (down to a hearing loss of ...
Tags: Oticon Medical, Ponto Plus Bone
Navidea Biopharmaceuticals has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for the approval to market and sale Lymphoseek Injection for sentinel lymph node (SLN) detection in patients ...
EMD Serono, a subsidiary of Merck KGaA, has announced that Gonal-f RFF Redi-ject, a disposable pre-filled drug injector pen intended for the subcutaneous injection of a liquid formulation of Gonal-f RFF, is now available in the US for ...
Tags: Health, Medicine, Redesigned Fertility Pen
Corgenix Medical, in collaboration with Randox Laboratories, has filed first 510(k) premarket notification with the US Food and Drug Administration (FDA) for the TxBCardio immunoturbidimetric assay. According to Corgenix Medical, ...
CSL Behring has announced that Kcentra (prothrombin complex concentrate [human]) has received the US Food and Drug Administration (FDA) approval for an expanded indication -- urgent reversal of acquired coagulation factor deficiency induced ...
Tags: CSL Behring, Medicine
Duke University’s Duke Clinical Research Institute (DCRI) has been selected by Oxygen Biotherapeutics, a pharmaceutical company, to conduct the Phase III clinical trial of the company’s newly acquired compound, levosimendan. ...
Ethicon Endo-Surgery has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its HARMONIC FOCUS+ shears with adaptive tissue technology. HARMONIC FOCUS+ now brings adaptive tissue technology to open procedures ...
Tags: Ethicon, HARMONIC FOCUS+, adaptive tissue, technology, HARMONIC
BSD Medical, a provider of medical systems, has signed an agreement with Active Medical for the sales and distribution of the MicroThermX Microwave Ablation line of products. Pursuant to the agreement, BSD recently commenced shipment of ...
Tags: BSD Medical, Active Medical, agreement, distribution agreement
Vascular Solutions, a medical device company, has obtained Shonin approvals from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its GuideLiner guide extension catheter and the SuperCross FT microcatheter. Japan Lifeline, ...
Tags: Vascular Solutions, medical device, MHLW, extension catheter
W. L. Gore & Associates (Gore) has obtained the US Food and Drug Administration (FDA) approval for its GORE VIABAHN endoprosthesis for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous ...
Tags: Gore, FDA, GORE VIABAHN, endoprosthesis, AV access
The US Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favorably by a majority that the benefits of the Boston Scientific's WATCHMAN left atrial appendage closure device ...
Tags: FDA, Boston Scientific, WATCHMAN, left atrial appendage closure device
Baxter International has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for the approval of a recombinant antihemophilic porcine sequence factor VIII called 'OBI-1' for the treatment of patients ...
US-based SynCardia Systems has announced the implantation of the 150th SynCardia temporary total artificial heart in 2013. The 150th SynCardia temporary total artificial heart has been implanted on 26 November 2013. In 2012, a total of ...
Tags: Heart Implant, Syncardia Systems
Baxter International has filed an application to the US Food and Drug Administration (FDA) for a pediatric indication for Rixubis [Coagulation Factor IX (Recombinant)] to treat hemophilia B. The submission was based on a Phase II/III ...
American Medical Systems, a provider of devices and therapies for male and female pelvic health, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its RetroArc retropubic sling system. Designed for the ...