(AOF) – Mauna Kea Technologies announces the first 510(k) clearance from the FDA for the use of the Cellvizio in a new category of endoscopic, laparoscopic and needle procedures guided by molecular imaging. This authorization is for the use of Cellvizio in the fluorescence imaging of tissues targeted by a molecular marker, Pafolacianin, marketed as Cytalux and manufactured by On Target Laboratories, in accordance with its approved use and method of administration. .
Additionally, the authorization includes a new clinical indication for the use of Cellvizio for fluorescence imaging and visualization of ICG (indocyanine green), intravenously or interstitially, in accordance with the use and direction. the approved method of administration of the ICG. The 510(k) includes all Cellvizio Confocal Miniprobes in all authorized clinical indications.
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Boost for French pharmacy
At the end of a recent CSIS, the French authorities announced an amount of credits (7 billion euros) never reached: 1.5 billion for hospital-university 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 expenditure reimbursed by Medicare will be 2.4%, which should generate growth of at least 0.5% in the turnover of laboratories,
Above all, the normal drug marketing procedure will be accelerated (up to 500 days saved) if the medical benefit rendered is sufficient.