I-FDA Igunyaza Isivivinyo Se-HistoSonics IDE Sokwelashwa Kwe-Sound Beam

I-HistoSonics eseMinneapolis ithuthukise uhlelo lwayo lwe-Edison ukuze luqondise futhi lubulale izimila zezinso ezihlosiwe.Uyenza ngokungena-invasively, ngaphandle kokusikwa noma izinaliti.U-Edison wasebenzisa indlela entsha yokwelapha yomsindo ebizwa ngokuthi i-histology.
I-HistoSonics isekelwa abanye babadlali abakhulu embonini yobuchwepheshe bezokwelapha.NgoMeyi 2022, inkampani yenza isivumelwano ne-GE HealthCare sokusebenzisa ubuchwepheshe bayo bezithombe ze-ultrasound ukuhlinzeka ngohlobo olusha lokwelashwa kwe-sound beam.NgoDisemba 2022, i-HistoSonics inyuse amaRandi ayizigidi ezingama-85 emzuliswaneni woxhaso owawuholwa nguJohnson & Johnson Innovation.
Le nkampani ithe ukugunyazwa kwe-FDA kocwaningo lwe-Hope4Kidney kusekelwe emiphumeleni yakamuva evela ocwaningweni lwe-Hope4Liver.Zombili izivivinyo zizuze ukuphepha kwazo okuyinhloko nokusebenza ngempumelelo ekuqondiseni izimila zesibindi.
"Lokhu kugunyazwa kuyisinyathelo esibalulekile enkampanini yethu njengoba siqhubeka nokwandisa ukusetshenziswa kobuchwepheshe bokusika izicubu kanye nezinzuzo ezingaba khona ekwelapheni izifo ezithinta impilo yabantu abaningi," kusho uMike Blue, uMongameli kanye ne-CEO ye-HistoSonics.Siyajabula ukwandisa ulwazi lwethu.ukukhomba ngempumelelo kanye nokwelapha esibindini kusetshenziswa inkundla yethu ye-Edison ethuthukisiwe, ehlanganisa amakhono athuthukile wokuthwebula izithombe kanye nokukhomba nokuqapha ukwelashwa kwesikhathi sangempela.
Ukwelashwa kwamanje kwamathumba ezinso kufaka phakathi i-nephrectomy eyingxenye kanye nokukhishwa kwe-thermal, kusho u-HistoSoncis.Lezi zinqubo ezihlaselayo zibonisa ukopha kanye nezinkinga ezithathelwanayo ezingagwenywa nge-non-invasive tissue biopsy, kusho inkampani.
Lokhu kwelashwa kungase kucekele phansi izicubu eziqondiwe ngaphandle kokulimaza izicubu zezinso ezingahlosiwe.Indlela yokubhujiswa kwamangqamuzana ezingxenyeni zezicubu ingase futhi igcine umsebenzi wohlelo lomchamo wezinso.
I-HistoSonics Image Guided Sound Beam Therapy isebenzisa izithombe ezithuthukisiwe kanye nobuchwepheshe bezinzwa obunelungelo lobunikazi.Ukwelashwa kusebenzisa amandla e-acoustic agxilile ukudala i-acoustic cavitation elawulwayo ukuze iphazamise ngomshini futhi igxilise izicubu zesibindi ezihlosiwe ezingeni elingaphansi.
Isiteji singanikeza nokululama ngokushesha nokuthatha, kanye nekhono lokuqapha, kusho inkampani.
U-Edison okwamanje akamakethwa, kusalinde ukubuyekezwa kwe-FDA ngezinkomba zezicubu zesibindi.Inkampani inethemba lokuthi izivivinyo ezizayo zizosiza ukwandisa izinkomba zezicubu zezinso.
"Isicelo esilandelayo esinengqondo kwakuyizinso, ngoba ukwelapha izinso kufana kakhulu nokwelashwa kwesibindi ngokucatshangelwa kwenqubo kanye ne-anatomical, futhi u-Edison uklanyelwe ngokukhethekile ukuphatha noma iyiphi ingxenye yesisu njengesiqalo," kusho uBlue.“Ngaphezu kwalokho, ukwanda kwesifo sezinso kusephezulu, futhi iziguli eziningi zigadiwe noma zilindile.”
Kufakwe Ngaphansi: Izivivinyo Zomtholampilo, Ukulawulwa Kokudla Nezidakamizwa (i-FDA), Ukufanekisa, I-Oncology, Ukuthobela Ukulawula / Ukuthobelana Nomaka: 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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Isikhathi sokuthumela: Feb-14-2023