Hologic, a manufacturer of diagnostic products, medical imaging systems and surgical products, has announced that the US Food and Drug Administration (FDA) has approved the Aptima HPV 16 18/45 genotype assay for use on the company's fully ...
Tags: aptima HPV, Hologic, panther system
Medtronic has obtained the US Food and Drug Administration (FDA) approval for its Lead Integrity Alert (LIA) software for use with non-Medtronic leads to detect defibrillator lead issues. LIA software has been approved by the FDA to ...
Tags: Medtronic, PDA, LIA, non-medtronic
NanoBio Systems, a medical sensor startup company, has announced the successful measurement of glucose in saliva of human test subjects using a disposable nanotechnology-based sensor platform and simple, portable electronics. Limited ...
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
IceCure Medical has announced that the John Wayne Cancer Institute (JWCI) at Saint John's Health Center in Santa Monica, California, treated its first breast cancer patient using the IceSense3 cryoablation system in a pilot study evaluating ...
W. L. Gore & Associates (Gore) has obtained an approval from the US Food and Drug Administration (FDA) for its 25cm GORE VIABAHN endoprosthesis with heparin bioactive surface. The 25cm Gore Viabahn endoprosthesis is intended to treat ...
Tags: disease heal, health, cure, fda
Seventh Sense Biosystems (Cambridge, MA) landed CE Mark approval in the European Union for its Touch Activated Phlebotomy platform. The platform is designed for blood collection procedures and is slated for release in one year or more. For ...
Approximately one year after the company landed FDA approval for its Ventricular Assist System, the company is boasting significant surge in revenue. In early morning trading on November 7, the company's shares increased by 15%. In total, ...
Medtronic has obtained an investigational device exemption from the US Food and Drug Administration (FDA) to initiate SYMPLICITY HTN-4 clinical trial using its Symplicity renal denervation system. SYMPLICITY HTN-4 study has been designed ...
Novocure announced that the US Food and Drug Administration (FDA) has approved the NovoTAL (Transducer Array Layout) system through a premarket approval (PMA) supplement. The NovoTAL System allows certified physicians to use the ...
Tags: Novotal System
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
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
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) ...
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 ...