The FDA granted 510(k) clearance to Neuronetics Inc.’s MT Cap technology for the company’s transcranial magnetic stimulation system, Neurostar Advanced Therapy for Mental Health. The MT Cap speeds the process used to determine the dose and motor threshold for treatment with the Neurostar system for major depressive disorder (MDD). The company expects to begin a limited introduction of the product within weeks, with national rollout to follow in the first quarter of 2022.
Brainsgate Ltd. came up short in a recent FDA advisory hearing for the company’s Ischemic Stroke System (ISS) to treat stroke despite that the panel was unanimously satisfied with the pivotal trial’s safety numbers. One of the issues with the pivotal study was the small enrollment of study subjects in the U.S., which demonstrates once again the hazards of relying on outside-U.S. study data in applications with the FDA.
The COVID-19 pandemic shone an unsparing light on counterfeit devices, but the FDA has previously enjoyed only limited authority to deal with those products. Thanks to legislation passed in January 2021, the agency now has authority to destroy imported counterfeit devices, including those combined with counterfeit drugs. The agency has had authority to destroy counterfeit drugs for a number of years, but that authority did not extend to counterfeit devices until passage of the Safeguarding Therapeutics Act of 2020, which was signed into law in January 2021.
PERTH, Australia – The FDA has given the green light to Telix Pharmaceuticals Ltd.’s lead radiopharmaceutical imaging agent, Illuccix, for prostate cancer. Illuccix is a kit for the preparation of gallium-68 (68Ga) prostate-specific membrane antigen (PSMA) 11 for imaging prostate cancer with positron emission tomography (PET). It targets PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells.
The FDA granted 510(k) clearance to Sky Medical Technology Ltd.’s Geko device for patients with venous insufficiency and/or ischemia. The neurostimulation device is worn at the knee and increases blood flow in lower limb soft tissue of patients. The company said it will initiate a controlled market release in partnership with U.S. clinicians in a bid to reshape venous insufficiency treatment.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Edwards Lifesciences, Neuronetics, Organox.
The U.K.’s National Institute for Health and Care Excellence (NICE) will welcome a new chief executive in February. Samantha Roberts was named to succeed Gillian Leng, who is retiring after 20 years at the agency. With extensive experience in health care delivery and as a clinician, Roberts currently serves as managing director for health and care at NHS England.
The European Council reached an agreement Dec. 20 that will allow the European Health Emergency Preparedness and Response Authority to respond much more quickly to public health emergencies such as the COVID-19 pandemic by activating urgent and targeted medical countermeasures (MCMs) across the EU.
Regulatory agencies across the globe had their hands full in 2020 and 2021 in responding to the COVID-19 pandemic, but that is just one reason that regulatory frameworks for artificial intelligence are lagging. Several regulatory proposals have been floated, but one of these hints at a need for regulatory harmonization, a requirement that seems certain to add yet more drag to a process that is already years behind the technology.
TORONTO – Hyperfine Inc. has received Health Canada approval for the first FDA-cleared portable magnetic resonance imaging (MRI) device, which also features advanced reconstruction deep learning software. The company simultaneously announced its commercial launch of the Swoop imaging system in Canada.
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