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.
In Belgium, the National Institute for Health and Disability Insurance, INAMI, will reimburse costs for mobile health care applications as part of a care pathway. The move follows the green light given recently by the health care insurance committee. Online platforms, mobile apps and connected devices all have grown in popularity in recent months against the backdrop of the COVID-19 pandemic.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA updates recognized standards list; Advisory hearing scheduled for Transmedics’ OCS; GAO said ‘no’ to Spartan Medical appeal; CDC posts updates on SARS sequencing.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accufix Surgical, Anuncia, Conformis, Fifth Eye, Guardant Health, Masimo, Neurolief.
Non-clinical testing for the SARS-CoV-2 virus has been a major goal for regulators across the globe for months. Emergency use authorization (EUA) was just granted by the FDA is for the Quidel Quickvue COVID-19 test, an at-home antigen test with a turnaround time of 10 minutes. It’s the latest in a series of approvals of home tests and collection kits that promises to help control the pandemic.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CRS: Supply chain for testing still under pressure; AHRQ eyes provider-to-provider telehealth; Health Canada emphasizes nursing homes in report on testing; Advamed, Georgia Bio sound off on EtO.
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