FDA waxay ogolaatay Tijaabada IDE HistoSonics ee Daawaynta Dhawaaqa

HistoSonics ee fadhigeedu yahay Minneapolis waxay horumarisay nidaamkooda Edison si ay u beegsadaan una dilaan burooyinka kelyaha aasaasiga ah ee la beegsaday.Wuxuu u sameeyaa si aan fiicneyn, iyada oo aan la jeexin ama irbado.Edison waxa uu isticmaalay daawaynta dhawaaqa cusub ee loo yaqaan histology.
HistoSonics waxaa taageeray qaar ka mid ah ciyaartoyda waaweyn ee warshadaha tignoolajiyada caafimaadka.Bishii Maajo 2022, shirkaddu waxay heshiis la gashay GE HealthCare si ay u isticmaasho tignoolajiyadeeda sawirka ultrasound si ay u bixiso nooc cusub oo daawaynta iftiinka dhawaaqa ah.Bishii Disembar 2022, HistoSonics waxay aruurisay $85 milyan wareeg maalgelineed oo ay hogaaminayeen Johnson & Johnson Innovation.
Shirkaddu waxay sheegtay in oggolaanshaha FDA ee daraasadda Hope4Kidney ay ku saleysan tahay natiijooyinkii ugu dambeeyay ee daraasadda Hope4Liver.Labada tijaaboba waxay ku guuleysteen badbaadadooda aasaasiga ah iyo dhibcooyinka waxtarka leh ee lagu beegsanayo burooyinka beerka.
"Oggolaanshahani waa guul muhiim u ah shirkadeena maadaama aan sii wadno ballaarinta codsiga tignoolajiyada jarjarista unugyada iyo faa'iidooyinka suurtagalka ah ee daaweynta cudurrada saameeya nolosha dad badan," Mike Blue, Madaxweynaha iyo Maamulaha HistoSonics.Waan ku faraxsanahay inaan ballaarino khibradeena.Beegsiga guusha leh iyo daaweynta beerka iyada oo la adeegsanayo madalkeena Edison ee horumarsan, taas oo isku darka sawir-qaadista horumarsan iyo awoodaha bartilmaameedka iyo la socodka daawaynta waqtiga-dhabta ah.
Daaweynta hadda ee burooyinka kelyaha waxaa ka mid ah nephrectomy qayb ah iyo ka-bax kuleyl ah, HistoSoncis ayaa yiri.Nidaamyadan soo-galitaanka ayaa muujinaya dhiig-baxa iyo dhibaatooyinka faafa ee laga yaabo inay ka fogaadaan biopsy unug aan fiicneyn, ayay tiri shirkaddu.
Daawayntani waxay suurtogal u tahay inay burburiso unugyada la beegsanayo iyada oo aan waxyeello u geysan unugyada kelyaha ee aan bartilmaameedka ahayn.Habka burburinta unugyada qaybaha unugyada ayaa sidoo kale laga yaabaa inay ilaaliso shaqada habka kaadida ee kelyaha.
HistoSonics Image Guideed Sound Beam Therapy waxay isticmaashaa sawir-qaadis horumarsan iyo tignoolajiyada dareemaha ee la aqoonsan yahay.Daaweyntu waxay isticmaashaa tamar dhawaaqeed diirada saaraysa si ay u abuurto cavitation acoustic ah oo la kantaroolay si farsamaysan loo carqaladeeyo oo loo liqo nudaha beerka ee la beegsanayo heerka unugyada hoose.
Goobtu waxay sidoo kale bixin kartaa soo kabasho degdeg ah iyo la wareegid, iyo sidoo kale awoodaha la socodka, shirkaddu waxay tiri.
Edison hadda lama suuq geyn, iyadoo la sugayo dib u eegista FDA ee tilmaamayaasha unugyada beerka.Shirkaddu waxay rajaynaysaa in tijaabooyinka soo socda ay gacan ka geysan doonaan ballaarinta calaamadaha unugyada kelyaha.
"Codsiga soo socda ee macquulka ah wuxuu ahaa kelyaha, sababtoo ah daaweynta kelyaha waxay aad ula mid tahay daaweynta beerka marka loo eego nidaamka iyo tixgelinta anatomical, Edison waxaa si gaar ah loogu talagalay in lagu daaweeyo qayb kasta oo caloosha ah sida bilawga," ayuu yiri Blue."Intaa waxaa dheer, faafitaanka cudurka kelyaha ayaa weli ah mid sarreeya, bukaanno badanna waxaa lagu hayaa ilaalin firfircoon ama sugaya."
Waxaa lagu xareeyay: Tijaabooyin Caafimaad, Maamulka Cuntada iyo Dawooyinka (FDA), Sawirka, Oncology, U Hogaansanaanta Sharci / 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.
Xuquuqda daabacaadda 2023 · WTWH Media LLC iyo shati bixiyaasheeda.Dhammaan xuquuqaha way xifdiyeenAgabka goobtan lama daabici karo, lama qaybin karo, lama gudbin karo, lama kaydin karo ama si kale looma isticmaali karo marka laga reebo ogolaanshaha hore ee WTWH Media.


Waqtiga boostada: Febraayo-14-2023