I-FDA ivuma uvavanyo lwe-IDE ye-HistoSonics ye-Sound Beam Therapy

I-HistoSonics esekwe eMinneapolis iphuhlise inkqubo yabo ye-Edison ukujolisa kwaye ibulale amathumba ezintso eziphambili ezijoliswe kuzo.Uyenza ngokungena-invasively, ngaphandle kokusika okanye iinaliti.U-Edison wasebenzisa unyango olutsha lwesandi olubizwa ngokuba yi-histology.
I-HistoSonics ixhaswa ngabanye babadlali abakhulu kwishishini lobugcisa bezonyango.NgoMeyi ka-2022, inkampani yangena kwisivumelwano ne-GE HealthCare ukuba isebenzise ubuchwepheshe bayo bokucinga nge-ultrasound ukubonelela ngohlobo olutsha lonyango lwe-sound beam.NgoDisemba ka-2022, i-HistoSonics inyuse i-85 yezigidi zeedola kumjikelo wenkxaso-mali okhokelwa nguJohnson & Johnson Innovation.
Inkampani ithe imvume ye-FDA yophononongo lwe-Hope4Kidney lusekwe kwizinto ezifunyenweyo kuphononongo lwe-Hope4Liver.Omabini amalingo afezekise ukhuseleko lwawo oluphambili kunye neziphumo zokuphumelela ekujoliseni amathumba esibindi.
"Le mvume ibaluleke kakhulu kwinkampani yethu njengoko siqhubeka nokwandisa ukusetyenziswa kwethekhnoloji ye-tissue slicing kunye neenzuzo zayo ezinokubakho kunyango lwezifo ezichaphazela ubomi babantu abaninzi," kusho uMike Blue, uMongameli kunye ne-CEO ye-HistoSonics.Siyavuya ukwandisa amava ethu.ukujoliswa ngempumelelo kunye nonyango kwisibindi kusetyenziswa iqonga lethu le-Edison eliphambili, elidibanisa i-imaging ephezulu kunye nobuchule bokujolisa kunye nokubeka iliso lonyango lwexesha langempela.
Unyango lwangoku lwezicubu zezintso lubandakanya i-nephrectomy engaphelelanga kunye nokukhutshwa kwe-thermal, utshilo u-HistoSoncis.Ezi nkqubo zihlaselayo zibonisa ukopha kunye neengxaki ezosulelayo ezinokuthintelwa nge-non-invasive tissue biopsy, inkampani yathi.
Olu nyango lunokuthi lutshabalalise izicubu ekujoliswe kuzo ngaphandle kokonakalisa izicubu zezintso ezingajoliswanga.Indlela yokutshatyalaliswa kweeseli kumacandelo e-tissue inokugcina umsebenzi wenkqubo yomchamo wezintso.
I-HistoSonics Umfanekiso oKhokelweyo nguNyango lweBeam usebenzisa i-imaging ephezulu kunye ne-patent sensor technology.Unyango lusebenzisa amandla e-acoustic agxininisiweyo ukudala i-cavitation elawulwayo ye-acoustic ukuphazamisa ngomatshini kunye nokucima izicubu zesibindi ezijoliswe kuyo kwinqanaba le-subcellular.
Iqonga linokubonelela ngokukhawuleza kunye nokuthatha, kunye nokukwazi ukubeka iliso, inkampani yathi.
I-Edison ayithengiswa okwangoku, ilindele ukuphononongwa kwe-FDA yezalathisi zezicubu zesibindi.Inkampani inethemba lokuba izilingo ezizayo ziya kunceda ukwandisa izalathiso zezicubu zezintso.
"Isicelo esilandelayo esinengqiqo sasiyintso, kuba unyango lwezintso lufana kakhulu nonyango lwesibindi ngokwemigaqo yenkqubo kunye ne-anatomical, kwaye i-Edison yenzelwe ngokukodwa ukuphatha nayiphi na inxalenye yesisu njengento yokuqala," kusho uBlue.Ukongeza, ukuxhaphaka kwesifo sezintso kuhlala kuphezulu, kwaye izigulana ezininzi ziphantsi kweliso elisebenzayo okanye zilindile.
Ifakwe Ngaphantsi: Iimvavanyo zeklinikhi, uKutya kunye noLawulo lweziyobisi (i-FDA), iMifanekiso, i-Oncology, ukuThotyelwa kweMithetho / ukuThotyelwa kweTag: 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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