FDA Yemeza Ikigereranyo cya HistoSonics IDE Ikigereranyo cyo Kuvura Amajwi

HistoSonics ikorera muri Minneapolis yateje imbere sisitemu ya Edison yo kwibasira no kwica ibibyimba byibanze byimpyiko.Irabikora idahwitse, idafite inshinge cyangwa inshinge.Edison yakoresheje uburyo bushya bwo kuvura amajwi bwitwa histology.
HistoSonics ishyigikiwe na bamwe mu bakinnyi bakomeye mu nganda zikoranabuhanga mu buvuzi.Muri Gicurasi 2022, isosiyete yagiranye amasezerano na GE HealthCare yo gukoresha ikoranabuhanga ryayo ryerekana amashusho ya ultrasound kugirango itange ubwoko bushya bwo kuvura amajwi.Ukuboza 2022, HistoSonics yakusanyije miliyoni 85 z'amadolari mu cyiciro cy'inkunga iyobowe na Johnson & Johnson Innovation.
Isosiyete yavuze ko FDA yemeye ubushakashatsi bwa Hope4Kidney ishingiye ku bushakashatsi buherutse gukorwa mu bushakashatsi bwa Hope4Liver.Ibigeragezo byombi byageze kumutekano wibanze no gukora neza muguhimba ibibyimba byumwijima.
Mike Blue, Perezida akaba n'Umuyobozi mukuru wa HistoSonics, yagize ati: "Iki cyemezo ni intambwe ikomeye ku kigo cyacu mu gihe dukomeje kwagura ikoreshwa ry'ikoranabuhanga ryo gutema ibice ndetse n'ingaruka zishobora kuvuka mu kuvura indwara zangiza ubuzima bw'abantu benshi."Twishimiye kwagura uburambe.gutsinda neza no kuvura umwijima ukoresheje urubuga rwacu rwa Edison rwateye imbere, rukomatanya ubushobozi bwo gufata amashusho hamwe nubushobozi bwo kugenzura hamwe nigihe cyo gukurikirana imiti.
HistoSoncis yavuze ko ubu kuvura ibibyimba by'impyiko birimo nephrectomy igice ndetse no gukuraho ubushyuhe.Isosiyete yavuze ko ubu buryo butera bwerekana kuva amaraso n’ingaruka zanduza zishobora kwirindwa hamwe na biopsy ya tissue idashobora gutera.
Ubu buvuzi bushobora gusenya ingirangingo zitarinze kwangiza impyiko zidafite intego.Uburyo bwo gusenya ingirabuzimafatizo mu bice bya tissue birashobora kandi kubungabunga imikorere yinkari zimpyiko.
HistoSonics Ishusho Yayoboye Ijwi Beam Ubuvuzi ikoresha amashusho yambere kandi yerekana tekinoroji ya sensor.Ubuvuzi bukoresha ingufu za acoustic zibanze kugirango habeho acoustic cavitation igenzurwa kugirango ihungabanye mu buryo bwa mashini no gutembagaza umwijima ugenewe urwego rudasanzwe.
Isosiyete yavuze ko urubuga rushobora kandi gukira vuba no gufata neza, ndetse n'ubushobozi bwo gukurikirana.
Edison ntabwo aracuruzwa muri iki gihe, mu gihe hagitegerejwe ko FDA isubiramo ibimenyetso byerekana umwijima.Isosiyete irizera ko ibigeragezo biri imbere bizafasha kwagura ibimenyetso byimpyiko.
Blue yagize ati: "Uburyo bukurikira bwakoreshejwe ni impyiko, kubera ko kuvura impyiko bisa cyane no kuvura umwijima mu buryo bwo gutekereza no mu buryo bwa anatomique, kandi Edison yagenewe by'umwihariko gufata igice icyo ari cyo cyose cy'inda nk'intangiriro."Ati: “Byongeye kandi, indwara z'impyiko zikomeje kuba nyinshi, kandi abarwayi benshi bakurikiranwa cyangwa bategereje.”
Filed Under: Igeragezwa rya Clinical, Ubuyobozi bwibiribwa nibiyobyabwenge (FDA), Kwerekana, Oncologiya, Kubahiriza Amabwiriza / Gukurikiza Tag: 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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Igihe cyo kohereza: Gashyantare-14-2023