Medtronic plc obtained the CE mark for its Sensight directional lead system for deep brain stimulation (DBS) for movement disorders and epilepsy, which is designed to be used with the company’s Percept PC DBS device. Percept received U.S. FDA clearance in June 2020 and CE mark in January 2020.
The COVID-19 pandemic has affected wide swaths of the global economy, mostly in a negative manner, but it has spurred some types of innovation at a rate that would be unimaginable in ordinary times. That seems to be the take-away for an emergency use authorization (EUA) granted to Miami-based Tiger Tech Solutions Inc. for its COVID Plus monitor, which uses plethysmography and a machine learning algorithm to provide a screening mechanism at mass gatherings, thus bringing the world one step closer to a state of normalcy.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: OIG hits Mississippi hospital for polysomnography claims; BD expands Chloraprep recall to all 50 states.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Recovery Force.
The latest global regulatory news, changes and updates affecting biopharma, including: MHRA resumes some onsite inspections; Kyprolis discount opens door to U.K. coverage; HHS delays Trump ‘Sunset’ rule.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chiasma, Clarus, Crinetics, Lumos, Neurocrine, Strongbridge, Rezolute, Rhythm, Theratechnologies.
Boston Scientific Corp.'s Therasphere Y-90 glass microspheres received a PMA for treatment of patients with unresectable hepatocellular carcinoma (HCC). The radioembolization technique has been used in more than 70,000 patients under a humanitarian device exemption over the last 20 years. The U.K.'s NICE also recently recommended Therasphere for treatment of patients with HCC.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: SUNSET rule suspended; Alliance calls for speedy nomination of FDA commissioner; Pandemic costly to TB effort; FDA announces May 4 patient data meeting.
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