FDA Inobvumira HistoSonics IDE Muedzo weInzwi Beam Therapy

Minneapolis-yakavakirwa HistoSonics yakagadzira yavo Edison system yekunanga nekuuraya yakanangwa ekutanga mamota eitsvo.Anozviita asingapindiri, pasina machekwa kana tsono.Edison akashandisa mushonga mutsva unonzwika unonzi histology.
HistoSonics inotsigirwa nevamwe vevatambi vakuru muindasitiri yehunyanzvi hwekurapa.Muna Chivabvu 2022, kambani yakapinda muchibvumirano neGE HealthCare yekushandisa tekinoroji yekufungidzira kweiyo Ultrasound kupa rudzi rutsva rweruzha rwerapi.Muna Zvita 2022, HistoSonics yakasimudza madhora makumi masere nemashanu emamiriyoni muchikamu chemari chinotungamirwa naJohnson & Johnson Innovation.
Kambani iyi yakati kubvumidzwa kweFDA kweTariro4Kidney kudzidza kwakavakirwa pane zvichangoburwa zvakawanikwa kubva kuHope4Liver kudzidza.Miyedzo yese iri miviri yakawana chengetedzo yavo yekutanga uye magumo ekuita mukunangana nemamota echiropa.
"Mvumo iyi idanho rakakosha kukambani yedu apo isu tichiramba tichiwedzera kushandiswa kwehunyanzvi hwekucheka matishu uye mabhenefiti angangove mukurapa kwezvirwere zvinokanganisa hupenyu hwevanhu vazhinji," akadaro Mike Blue, Mutungamiriri uye CEO weHistoSonics.Isu tinofara kuwedzera ruzivo rwedu.yakabudirira kunanga uye kurapa muchiropa tichishandisa yedu yepamusoro Edison chikuva, icho chinosanganisa kufungidzira kwepamberi uye kugona kunanga nekugona-chaiyo-nguva yekurapa yekutarisa.
Ikozvino marapirwo emamota eitsvo anosanganisira chikamu chenephrectomy uye kubviswa kwemafuta, HistoSoncis akadaro.Aya maitiro ekupinda anoratidza kubuda ropa uye matambudziko ekutapukira anogona kudzivirirwa neasina-invasive tishu biopsy, kambani yakati.
Kurapa uku kunogona kuparadza nyama yakanangwa pasina kukuvadza itsvo isiri-yakananga tishu.Iyo nzira yekuparadza masero muzvikamu zvenyama inogonawo kuchengetedza kushanda kweurinary system yeitsvo.
HistoSonics Image Inotungamirirwa Inzwi Beam Therapy inoshandisa kufungidzira kwepamusoro uye patented sensor tekinoroji.Mushonga wacho unoshandisa yakanangidzirwa acoustic simba kugadzira inodzorwa acoustic cavitation kuti inokanganisa nemagetsi uye kunyungudutsa chiropa chinonangwa pane imwe subcellular level.
Iyi puratifomu inogona zvakare kupa nekukurumidza kupora uye kutora, pamwe nekutarisa kugona, kambani yakati.
Edison parizvino haisati yatengeswa, ichimirira FDA kuongororwa kwechiropa tishu zviratidzo.Iyo kambani inotarisira kuti miyedzo iri kuuya ichabatsira kuwedzera zviratidzo zveitsvo.
"Kushandiswa kwakatevera kunonzwisisika kwaiva itsvo, nokuti kurapa kweitsvo kwakafanana zvikuru nekurapa kwechiropa maererano nemaitiro uye anatomical kufunga, uye Edison yakanyatsogadzirirwa kubata chero chikamu chedumbu sekutanga," akadaro Blue."Uyezve, kuwanda kwechirwere cheitsvo kunoramba kwakakwira, uye varwere vazhinji vari pasi pekutariswa kana kumirira."
Yakaiswa Pasi pe: Clinical Miedzo, Chikafu neDrug Administration (FDA), Imaging, Oncology, Regulatory Compliance / Tag Kutevedzera: 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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Nguva yekutumira: Feb-14-2023