CAJICA, Colombia – Chembio Diagnostic Systems Inc., a point-of-care diagnostic company focused on infectious diseases, received the approval from Anvisa, the Brazilian health care surveillance agency, to distribute its tests in the Latin American market. The approval adds yet another test to the hundreds already approved in Brazil, where the market for such tests is quickly getting crowded sending prices down. Brazil is one of the countries most affected by COVID-19 with almost 6 million cases and 166,000 deaths, the third highest number of cases in the world.
Recent advances in biomarkers and imaging capabilities have improved the diagnosis of Alzheimer’s disease (AD). Fujirebio Diagnostics Inc. aims to further expand the arsenal of AD diagnostics with its Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test. On Wednesday, the company said it had filed a 510(k) submission with the U.S. FDA for premarket clearance of the Lumipulse G β-Amyloid IVD.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Etiometry, Modulim, Nico.Lab, Roche, University of California.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA slaps two companies for illicit COVID offerings; FDA approves new PET imaging agent for prostate cancer.
Cerus Corp. has received the green light from the U.S. FDA for its Intercept blood system for cryoprecipitation. The device, which garnered a breakthrough device designation in 2018, is used to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex (PR-Cryo) for treating and controlling bleeding, including massive hemorrhage, associated with fibrinogen deficiency.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GAO, National Academies report on AI in health care; Commerce begins assessment of U.S. drug, device manufacturing base.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bearpac Medical, Hologic.
The U.S. FDA’s device user fee schedule doubled for both the third and fourth user fee agreements over the prior iterations, but the pressure against another doubling for the fifth iteration of the user fee program is mounting. The Medical Imaging & Technology Alliance (MITA) said it sees a need to retain the user fee programs that are working and to jettison any underperforming programs, adding that user fees “should be stabilized around current funding levels.”
The U.S. FDA has granted 510(k) clearance to Siemens Healthineers AG for AI-Rad Companion Organs RT, the newest module in its platform of artificial intelligence-based software assistants. The radiation therapy planning aide joins earlier AI-Rad Companion modules for interpreting magnetic resonance imaging (MRI) studies of the brain and prostate, as well as one for chest computed tomography (CT) studies.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FMCSA declines to allow ICD patients a commercial license; Pandemic not the time for trade restrictions.
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