Cue Health Inc. became the first company to offer COVID-19 molecular testing for home use without a prescription following U.S. FDA emergency use authorization on March 5, 2021. The San Diego-based company’s isothermal nucleic acid amplification test (NAAT) detects RNA from SARS-CoV-2 virus present in the nostrils. “The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “Cue COVID-19 Test for Home and Over-the-Counter (OTC) Use provides access to accurate and reliable testing at-home, without a prescription.”
Medical device startup Promaxo Inc. has received 510(k) clearance from the U.S. FDA for its office-based MRI system. The portable system is intended for use by urologists and interventional/urologic radiologists who are performing surgical localization of prostatic lesions under Promaxo MRI guidance. It can be used in the office or outpatient surgical setting without the need for significant facility upgrades.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA blasts thermographic sensor system marketers; WHO to tackle breast cancer globally; PhRMA urges Biden to stand by IP rights; FDA ASCA workshop announced.
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.
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.
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.
From the time it paused inspections of drug manufacturing sites a year ago due to the COVID-19 pandemic, the FDA conducted only three foreign “mission-critical” inspections in fiscal 2020. Those were in Canada, Germany and India, according to a new U.S. Government Accountability Office report.
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.
A new once-daily attention deficit hyperactive disorder (ADHD) drug developed by prodrug specialist Kempharm Inc. has won FDA approval under the brand name Azstarys. The medicine combines serdexmethylphenidate, Kempharm's prodrug of the CNS stimulant dexmethylphenidate, with immediate-release d-MPH, the core medicine in the now off-patent product Focalin, a refined formulation of Ritalin.
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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