PERTH, Australia – The majority of stakeholders support the Therapeutic Goods Administration’s (TGA) proposal to restructure Australia’s device essential principles to align with the requirements under the new EU Medical Device Regulations (EU MDR), but there was little support to align with the International Medical Device Regulators Forum (IMDRF) essential principles and principles of labeling.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cue Health.
As expected, Viela Bio Inc. won FDA clearance for the humanized anti-CD19 monoclonal antibody Uplizna (inebilizumab-cdon) to treat adults with neuromyelitis optica spectrum disorder (NMOSD), a rare neuroinflammatory disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adial, Biovie, Kite, Leap, Viela, ZZ.
Medtronic plc, of Dublin, has gained CE-marking approval for its Minimed 780g system, a next-generation closed-loop insulin pump for people with type 1 diabetes between the ages of 7 and 80 years old. The advanced hybrid closed-loop system (AHCL) features an advanced autocorrection algorithm and Bluetooth connectivity.
The U.S. FDA granted San Diego-based Illumina Inc. an emergency use authorization (EUA) for the first COVID-19 diagnostic test that uses next-generation sequencing (NGS). In addition to diagnosing infection with SARS-CoV-2, the COVIDSeq test can help researchers track mutations in the coronavirus.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Lucid Diagnostics, Moleculight, Palmetto GBA, Pavmed.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Establishment Labs, Medtronic.
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