FDA Ivomereza Kuyesa kwa HistoSonics IDE kwa Sound Beam Therapy

HistoSonics yochokera ku Minneapolis idapanga makina awo a Edison kuti awone ndikupha zotupa zazikulu za impso.Amachita mosavutikira, popanda kudulidwa kapena singano.Edison anagwiritsa ntchito njira yatsopano yopangira mawu yotchedwa histology.
HistoSonics imathandizidwa ndi ena mwa osewera akulu mumakampani azaukadaulo azachipatala.Mu Meyi 2022, kampaniyo idachita mgwirizano ndi GE HealthCare kuti igwiritse ntchito ukadaulo wake wa kujambula kwa ultrasound kuti ipereke mtundu watsopano wamankhwala opangira mawu.Mu Disembala 2022, HistoSonics idakweza $85 miliyoni pothandizira ndalama motsogozedwa ndi Johnson & Johnson Innovation.
Kampaniyo idati kuvomereza kwa FDA kwa kafukufukuyu wa Hope4Kidney kutengera zomwe zapeza posachedwa kuchokera ku kafukufuku wa Hope4Liver.Mayesero onsewa adakwaniritsa chitetezo chawo choyambirira komanso kuthekera kwawo pakutsata zotupa zachiwindi.
"Chivomerezo ichi ndi chofunikira kwambiri kwa kampani yathu pamene tikupitiriza kukulitsa kugwiritsa ntchito teknoloji yodula minofu komanso ubwino wake pochiza matenda omwe amakhudza miyoyo ya anthu ambiri," adatero Mike Blue, Purezidenti ndi CEO wa HistoSonics.Ndife okondwa kukulitsa zomwe takumana nazo.kulunjika bwino ndi kuchiza pachiwindi pogwiritsa ntchito nsanja yathu yapamwamba ya Edison, yomwe imaphatikiza luso lapamwamba la kuyerekezera ndi kulunjika ndi kuwunika kwenikweni kwamankhwala.
Chithandizo chamakono cha zotupa za impso chimaphatikizapo nephrectomy pang'ono ndi kutulutsa matenthedwe, HistoSoncis adati.Njira zowukirazi zikuwonetsa zovuta zamagazi komanso zopatsirana zomwe zitha kupewedwa ndi biopsy yosasokoneza minofu, kampaniyo idatero.
Kuchiza kumeneku kumatha kuwononga minofu yomwe mukufuna popanda kuwononga minofu yaimpso yomwe siikufuna.Limagwirira chiwonongeko cha maselo mu minofu zigawo akhoza kusunga ntchito ya kwamikodzo dongosolo impso.
HistoSonics Image Guided Sound Beam Therapy imagwiritsa ntchito matekinoloje apamwamba kwambiri oyerekeza ndi matekinoloje a sensor.Thandizo limagwiritsa ntchito mphamvu zamayimbidwe kuti zipangitse kuwongolera kwamayimbidwe acoustic cavitation kuti asokoneze ndi kusungunula minofu yachiwindi pamlingo wa subcellular.
Pulatifomuyo imathanso kupereka kuchira mwachangu komanso kulandidwa, komanso kuthekera kowunika, kampaniyo idatero.
Edison sakugulitsidwa pano, podikirira kuwunika kwa FDA pazowonetsa zamafuta a chiwindi.Kampaniyo ikuyembekeza kuti mayesero omwe akubwera athandiza kukulitsa zisonyezo za minofu ya impso.
"Zotsatira zomveka zogwiritsira ntchito zinali impso, chifukwa chithandizo cha impso ndi chofanana kwambiri ndi kuchiza kwa chiwindi potsata ndondomeko ndi matupi a anatomical, ndipo Edison amapangidwa makamaka kuti azisamalira mbali iliyonse ya mimba ngati poyambira," adatero Blue."Kuphatikiza apo, kuchuluka kwa matenda a impso kumakhalabe kwakukulu, ndipo odwala ambiri amayang'aniridwa kapena akudikirira."
Adasungidwa Pansi: Mayesero Achipatala, Food and Drug Administration (FDA), Imaging, Oncology, Regulatory Compliance / Tag Compliance: 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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Nthawi yotumiza: Feb-14-2023