Ka Whakaaetia e te FDA te Whakamātautau HistoSonics IDE mo te Whakamaori Kurupae Oro

I whakawhanakehia e HistoSonics a Minneapolis ta raatau punaha Edison ki te whaaia me te patu i nga pukupuku whatukuhu tuatahi.Ka mahia e ia ma te kore e pokanoa, kaore he werohanga, he ngira ranei.I whakamahia e Edison tetahi rongoa tangi hou e kiia nei ko te histology.
Kei te tautokohia a HistoSonics e etahi o nga kaitakaro nui o te umanga hangarau rongoa.I te marama o Haratua 2022, i uru te kamupene ki tetahi kirimana me GE HealthCare ki te whakamahi i tana hangarau whakaahua ultrasound hei whakarato i tetahi momo rongoa kurupae tangi.I te Hakihea 2022, i kohia e HistoSonics te $85 miriona i roto i te rauna putea i arahina e Johnson & Johnson Innovation.
I kii te kamupene ko te whakaaetanga a te FDA mo te ako Hope4Kidney i runga i nga kitenga hou mai i te rangahau Hope4Liver.Ko nga whakamatautau e rua i tutuki to raatau haumaru tuatahi me te whai hua ki te whai i nga pukupuku ate.
"Ko tenei whakaaetanga he tohu nui mo to taatau kamupene i te mea kei te whakawhānui tonu matou i te whakamahinga o te hangarau tapahi kiko me ona painga pea mo te maimoatanga o nga mate e pa ana ki te oranga o te tini o nga tangata," ko ta Mike Blue, te Perehitini me te Tumuaki o HistoSonics.Kei te koa matou ki te whakawhānui ake i to maatau wheako.te whai angitu me te rongoa i roto i te ate ma te whakamahi i to maatau papaarangi Edison matatau, e whakakotahi ana i nga whakaahua matatau me te whai kaha ki te aro turuki i te waa tuuturu.
Ko nga maimoatanga o naianei mo nga pukupuku whatukuhu ko te nephrectomy waahanga me te whakakorenga wera, e kii ana a HistoSoncis.Ko enei tikanga whakaeke e whakaatu ana i te toto me nga mate hopuhoputanga ka taea te karo me te koiora kore-invasive kiko, ka kii te kamupene.
Ka taea e tenei rongoa te whakangaro i te kopa i whaaia me te kore e pakaru i te kiko whatukuhu kore e whaaia.Ko te tikanga o te whakangaromanga o nga pūtau i roto i nga waahanga kiko ka taea hoki te pupuri i te mahi o te punaha urinary o nga whatukuhu.
Ko HistoSonics Image Guided Sound Beam Therapy e whakamahi ana i te atahanga matatau me te hangarau puoro arai.Ka whakamahia e te rongoa te kaha oro oro ki te hanga i te cavitation acoustic e whakahaeretia ana ki te whakakorikori me te whakangawari i te kiko ate i te taumata o raro.
Ka taea hoki e te papaaho te whakaora tere me te tango, me te kaha ki te tirotiro, ka kii te kamupene.
Kaore a Edison i te maakete i tenei wa, e tatari ana ki te arotake a te FDA mo nga tohu kiko ate.Ko te tumanako a te kamupene ko nga whakamatautau e haere ake nei ka awhina i nga tohu mo te kiko whatukuhu.
"Ko te tono arorau i muri mai ko te whatukuhu, no te mea he tino rite te rongoa o te whatukuhu ki te rongoa ate i runga i nga tikanga me nga whakaaro tinana, a ko Edison te mea i hangaia hei rongoa i tetahi waahanga o te kopu hei timatanga," ko ta Blue."I tua atu, kei te kaha tonu te mate o te mate whatukuhu, he maha nga turoro kei te tirotirohia, kei te tatari ranei."
I tukuna ki raro: Nga Whakamatautau Hauora, Whakahaere Kai me te Taakaro (FDA), Ataata, Oncology, Whakaritenga Ture / Tautukunga Tohu: 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.
Mana pupuri © 2023 · WTWH Media LLC me ona raihana.Katoa nga mana.Ko nga rauemi kei runga i tenei papanga kaore e taea te whakaputa, te tohatoha, te tuku, te keteroki, te whakamahi kee atu ranei engari me te whakaaetanga a-tuhi o mua a WTWH Media.


Wā tuku: Feb-14-2023