Medtronic plc (Dublin, Ireland) announced it received FDA approval for the Percept PC Deep Brain Stimulation (DBS) system. BrainSense technology makes Percept the first and only DBS neurostimulation system with the ability to chronically capture and record brain signals while delivering therapy to patients with neurologic disorders associated with Parkinson’s disease, essential … [Read more...]
Stat-Technologies receives Emergency Use Authorization for COVID-19 IgG/IgN rapid test kits
Stat-Technologies (Golden Valley, MN) announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for the COVID-19 IgG/IgN rapid test kits it carries. The tests offered by Stat-technologies are manufactured by Healgen Scientific. According to the company, the FDA authorization and Preferred-Provider status allows … [Read more...]
Sekisui Diagnostics announces FDA clearance, CLIA Waiver of OSOM Ultra Plus Flu A&B Test
Sekisui Diagnostics announced it received FDA clearance and CLIA Waiver of the OSOM Ultra Plus Flu A&B Test intended for the qualitative detection of influenza type A and type B nucleoprotein antigens directly from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. According tot he company, the test utilizes … [Read more...]