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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Illumina, Second Sight.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Controlrad, Misonix.
TORONTO – Front Line Medical Technologies Inc. reported Health Canada approval for a device deemed the smallest for use in emergency situations when patients require hemodynamic support to maintain blood flow to the brain and heart. According to biomedical engineer, co-founder and Front Line CEO Asha Parekh, the Cobra-OS is the world’s smallest REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) device.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GAO reviews FEMA's pandemic supply chain management efforts; Testing lab owner sentenced to three years; Health Canada renews interim order for importation of devices; FDA: claims of registration certificates may be misleading; MDCG issues gap guidance pending Eudamed completion; FDA seeking nominations for advisory committee.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Asensus Surgical, Medalliance.
The FDA has granted de novo authorization to Fifth Eye Inc. for its Analytic for Hemodynamic Instability (AHI), a machine learning (ML)-based, real-time indicator of patient deterioration. Commercialization of the software device, which continuously monitors patients with an electrocardiogram (ECG) for signs of deterioration, got underway on March 1.
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