Fa'amaonia e le FDA le Su'ega a le HistoSonics IDE mo le To'a'i Fa'asolo

O le HistoSonics e fa'avae i Minneapolis na atia'e le latou Edison system e fa'atatau ma fa'atama'i totoga fatuga'o muamua.Na te faia e aunoa ma se osofaʻiga, e aunoa ma se tipi poʻo ni nila.Na fa'aaogaina e Edison se togafitiga fou e ta'ua o le histology.
HistoSonics o loʻo lagolagoina e nisi o taʻaloga tetele i le falemaʻi tekonolosi faʻafomaʻi.I le masina o Me 2022, na osia ai e le kamupani se maliliega ma GE HealthCare e faʻaoga ai ana tekinolosi faʻataʻitaʻiga ultrasound e tuʻuina atu ai se ituaiga fou o togafitiga faʻalogo.Ia Tesema 2022, na siitia ai e le HistoSonics le $85 miliona i se taamilosaga faatupeina na taitaia e Johnson & Johnson Innovation.
Fai mai le kamupani o le faʻatagaina e le FDA o le Hope4Kidney suʻesuʻega e faʻavae i luga o suʻesuʻega lata mai mai le suʻesuʻega Hope4Liver.O fa'ata'ita'iga uma e lua na ausia a latou fa'ai'uga muamua o le saogalemu ma le aoga i le fa'atatauina o tuma o le ate.
"O lenei faʻatagaga o se mea taua tele mo la matou kamupani aʻo matou faʻaauau pea ona faʻalauteleina le faʻaogaina o tekinolosi faʻapipiʻi maʻa ma ona aoga aoga i le togafitiga o faʻamaʻi e aʻafia ai olaga o le toʻatele o tagata," o le tala lea a Mike Blue, Peresitene ma Pule Sili o HistoSonics.Matou te fiafia e faʻalautele lo matou poto masani.taula'i manuia ma togafitiga i le ate e fa'aaoga ai la tatou fa'asologa maualuga Edison, lea e tu'ufa'atasia ai fa'ata'ita'iga fa'ata'ita'i ma agava'a fa'atatau ma le mata'ituina o togafitiga moni.
O togafitiga o loʻo iai nei mo fatugaʻo e aofia ai le nephrectomy vaega ma le faʻamalo vevela, o le tala lea a HistoSoncis.O nei faʻalavelave faʻalavelave e faʻaalia ai le tafe toto ma faʻamaʻi pipisi e mafai ona aloese mai le biopsy o le tino e le faʻaleagaina, o le tala lea a le kamupani.
O lenei togafitiga e ono fa'aleagaina ai le aano o lo'o taula'i e aunoa ma le fa'aleagaina o aano fatuga'o e le o fa'atatauina.O le faiga o le fa'aleagaina o sela i vaega o le tino e mafai fo'i ona fa'asaoina le gaioiga o le urinary system o fatuga'o.
O le HistoSonics Image Guided Sound Beam Therapy e fa'aogaina ai ata fa'ata'ita'i ma fa'atekonolosi masini pateni.O le togafitiga e fa'aogaina ai le malosi o le leo e fa'atupu ai le fa'alogo leo e fa'atonuina e fa'alavelaveina ma fa'amama ai le aano o le ate o lo'o fa'atatau i se vaega i lalo o le tino.
O le tulaga e mafai foi ona maua vave le toe faʻaleleia ma le faʻaaogaina, faʻapea foʻi ma le mataʻituina o gafatia, o le tala lea a le kamupani.
E le'o maketiina Edison i le taimi nei, o lo'o fa'atali le iloiloga a le FDA mo fa'ailoga o le ate.O loʻo faʻamoemoe le kamupani o faʻataʻitaʻiga o loʻo lumanaʻi o le a fesoasoani e faʻalautele faʻailoga mo fatugaʻo.
"O le faʻaoga talafeagai e sosoo ai o le fatugaʻo, aua o le togafitiga o fatugaʻo e talitutusa lava ma le togafitiga o le ate i tulaga o faʻataʻitaʻiga ma iloiloga faʻapitoa, ma Edison ua faʻapitoa e togafitia soʻo se vaega o le manava o se amataga," o le tala lea a Blue."E le gata i lea, o le faʻateleina o faʻamaʻi fatugaʻo e tumau pea le maualuga, ma o le tele o gasegase o loʻo i lalo o le mataʻituina ma le faʻatali."
Fa'aulu i lalo: Fa'ata'ita'iga Fa'afoma'i, Fa'afoega o Mea'ai ma Fualaau Fa'asaina (FDA), Fa'ata'ita'iga, Oncology, Fa'atonu Fa'atonu / Tausia Fa'ailoga: HistoSonics Inc.
Sean Wooley is an Associate Editor writing for MassDevice, Medical Design & Outsourcing and Business News for drug delivery. He holds a bachelor’s degree in multiplatform journalism from the University of Maryland at College Park. You can reach him via LinkedIn or email shooley@wtwhmedia.com.
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Taimi meli: Feb-14-2023