(AOF) – Mauna Kea Technologies, inventor of Cellvizio, the multidisciplinary mini-probe and needle confocal laser endomicroscopy platform, has received a new 510 (k) clearance from the FDA to market its new Cellvizio platform generation and all confocal mini probes, combined with a fluorescent marker, fluorescein, for an additional indication allowing visualization of blood flow. This is the 19th 510 (k) clearance received from the FDA for the Cellvizio platform.
“This new FDA clearance for our next-generation Cellvizio platform in combination with a fluorescent contrast agent is further validation of Cellvizio’s unique ability to image, in real time, in vivo and at the cellular level, microvasculature and cells. capillaries, and represents a major regulatory step for Mauna Kea Technologies, “commented Robert L. Gershon, Managing Director of Mauna Kea Technologies.
“Our next-generation Cellvizio platform will be showcased to the international community of gastroenterologists and gastrointestinal surgeons at the American Foregut Society (AFS) and Viszeralmedizin (DGVS) conferences this September in Nashville, TN, USA. United States and Leipzig in Germany, respectively, and is now available for sale. ”
LEXICON
FDA (Food and Drug Administration)
Among the responsibilities of the Food and Drug Administration (the health authority in the United States) is notably the issuance of marketing authorizations for all drugs intended for this country, which represents the world’s largest market for the United States. ‘pharmaceutical industry.
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Boost for French pharmacy
At the end of a recent CSIS, the French authorities announced an unprecedented amount of credits (7 billion euros): 1.5 billion for university hospital research, 2 billion for investment in health via bpi France , 1.5 billion in aid for the relocation of industrial projects, and 2 billion to strengthen investment in three sectors of the future (bioproduction, digital medicine, and pandemic preparedness). In addition, the annual growth in drug expenses reimbursed by Medicare will be 2.4%, which should generate growth of at least 0.5% in laboratory turnover,
Above all, the normal drug marketing procedure will be accelerated (up to 500 days saved) if the actual benefit is sufficient.
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