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
W. L. Gore & Associates (Gore) has obtained CE Mark approval for its GORE EXCLUDER iliac branch endoprosthesis, designed for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. Gore has designed the iliac ...
Tags: CE, Gore, GORE EXCLUDER, product line
The US Food and Drug Administration (FDA) has approved Sunovion Pharmaceuticals' (Sunovion) antiepileptic drug (AED) Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in patients with epilepsy. According to the ...
Tags: FDA, Sunovion, partial-onset seizure, epilepsy
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 ...
Synutra International, Inc. ("Synutra" or the "Company"), which owns subsidiaries in China that produce, distribute and sell nutritional products for infants, children and adults, today announced financial results for the second quarter and ...
Tags: Synutra, Nutritional ingredients
US-based medical device company Veniti has obtained CE Mark approval for its Veniti Vici venous stent, designed for venous obstruction treatment. The company has also obtained CE Mark approval for its Veniti Veni RF plus ablation system, ...
Tags: venous obstruction treatment, varicose vein ablation product, heal
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
The U.S. Environmental Protection Agency (EPA) has released a Federal Register Notice seeking public input on a new insect repellent graphic for skin-applied insect repellent product labels. The graphic, which may be applied voluntarily by ...
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 ...
One Lambda, a part of Thermo Fisher Scientific, has obtained CE Mark approval for its C1qScreen assay in Europe. Utilizing Luminex-based single antigen beads, the C1qScreen solid-phase assay allows clinicians to further characterize ...
Tags: One Lambda, C1qscreen Assay
Danish medical device company FBC Device has obtained CE Mark approval for its Statur-L, a spinal fusion implant. FBC Device has also obtained International Organization for Standardization certification for maintaining highest quality ...
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