The FDA issued an advisory about the use of thermal imaging systems as screening instruments for the COVID-19 pandemic landing the same day as a warning letter to Certify Global Inc. The agency’s concern is that these systems are being used without consideration for the limitations, including that they are not appropriate for mass screenings due to inaccurate findings that could elevate the risk of spread of the SARS-CoV-2 virus.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CDSCO eyes recognition of ASTM standards; Device makers, docs blast radiation oncology payment model.
More than a decade after first approving Actemra (tocilizumab) for the treatment of rheumatoid arthritis, the FDA has added a sixth use to its label: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Illumina, Second Sight.
China’s most important annual government meetings, known as the “Two Sessions,” kicked off March 4 and biopharma executives that were also delegates to the National People's Congress (NPC) suggested that approval for trials should be stricter to avoid repetitive R&D and called for innovative drugs to get into the state insurance list – and to patients – faster.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Betta, Kintor, Moderna, Ocular, Roche, Seqirus, Sigilon, Turnsole.
Neurolief Ltd. received FDA clearance for its Relivion system for home treatment of acute migraine. The noninvasive multichannel brain neuromodulation system, worn as a headset, stimulates the occipital and trigeminal nerves.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: AHRQ: Patient portals underused in ED visits; Butterfly IQ scores well on cost, but supporting data limited.
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