FDA Holds NGS Webinars
The FDA will host two webinars on July 27 to provide details on its guidances on next-generation sequencing technologies.
The draft guidances are part of President Obama’s Precision Medicine Initiative, which aims to take advantage of genomic testing to accelerate the development of new personalized treatments.
The agency released two complementary draft guidances earlier this month that set a foundation for a flexible regulatory pathway for genomic tests. The pathway streamlines submission and review of data supporting clinical validity of NGS-based in vitro diagnostics (). For information on how to register, visit: www.fdanews.com/07-21-16-NGSwebinars.pdf.
FDA Seeks Patient Feedback
The FDA’s Center for Devices and Radiological Health is hosting an Aug. 1 workshop to solicit feedback from patients about their experiences with neurostimulation devices.
The workshop will explore patient experiences regarding the usability, benefits, and desired features of assistive and neurostimulation devices associated used to treat diabetes, macular degeneration and neurological diseases. For information, visit: www.fdanews.com/07-21-16-FDApatientworkshop.pdf.
BMS Launches Orencia Combo Product
Bristol-Myers Squibb launched its combination Orencia ClickJect for adults with moderate to severe rheumatoid arthritis. The Orencia auto injector delivers 125 mg subcutaneously via push button operation and injection confirmation, which may reduce user errors.
Orencia is the only RA biologic that offers three administration options: IV infusion, prefilled syringe and Autoinjector.
WHO Prequalifies Alere HIV Test
Alere’s HIV combo test received World Health Organization prequalification status. The fourth-generation test detects both HIV-1/2 antibodies and the HIV-1 p24 antigen. The WHO prequalification status means it will be available for public sector procurement in poorer nations.
Essential Medicine Gains CE Mark
Essential Medicine’s Manta gained CE Mark clearance in the European Union.
The large bore vascular closure device improves access site management for large-bore interventions. It is designed to close punctures after cardiac catheterization procedures.
Closure of large bore femoral access sites has been associated with significant morbidity including long times to achieve hemostasis, extended procedure time, need for a vascular surgeon in the catheterization lab, delayed ambulation, higher rate of complications and higher total cost of care.
FDA Approves Celt ACD
The FDA granted premarket approval to Irish devicemaker Vasorum’s vascular closure device Celt ACD. The single-use device for closing femoral artery punctures comes in three sizes. It can be used in both diagnostic procedures and for interventional cardiology and radiology procedures.