FDA ta Amince da Nazarin Nazari don Nazarin Kwayoyin Halitta na Liquid

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Written by Linda Hohnholz

Zayyanawa da yarda suna nuna mahimman cibiyoyi a cikin ci gaban Insightec Blood Brain Barrier (BBB) ​​taswirar hanyar asibiti ta amfani da Acoustic Therapy.  

Insightec a yau ta sanar da cewa ta sami amincewar FDA na keɓancewar na'urar bincike mai mahimmanci guda biyu (IDE) don tsarinta na Exablate Neuro - na farko don ciwon huhu na huhu na farko (NSCLC) wanda ya daidaita zuwa kwakwalwa tare da daidaitaccen kulawa. Keytruda®, kuma ɗaya don ingantaccen ingancin biopsy na ruwa don sake dawowar marasa lafiya da ciwon daji na farko na kwakwalwa. FDA ta kuma ba da sunan "Na'urar Ƙarfafawa" don maganin NSCLC, yana taimakawa wajen haɓaka haɓakawa da sake dubawa.

Insightec yana shirin ƙaddamar da binciken LIMITLESS (NSCLC) don tantance fa'idar asibiti ta yin amfani da mara amfani, ƙarancin ƙarfin duban dan tayi tare da tsarin rigakafi a cikin kula da marasa lafiya tare da ƙwayoyin kwakwalwa daga ciwon huhu. 

"Amfani da ƙananan ƙarfin mayar da hankali ga duban dan tayi (LIFU) tare da microbubbles don buɗe shingen kwakwalwar jini (BBB) ​​wani ci gaba ne mai ban sha'awa a cikin neuro-oncology wanda ke da alƙawarin zama canjin yanayi a cikin kula da marasa lafiya da ciwon kwakwalwa," ya ce babban mai binciken Dr. Manmeet Ahluwalia, MD, MBA, Babban Jami'in Lafiyar Tumor Medical Oncology, Mataimakin Darakta da Babban Jami'in Kimiyya a Cibiyar Ciwon daji ta Miami, wani ɓangare na Kiwon Lafiyar Baptist ta Kudu Florida. "Haɗin kai na musamman na LIFU BBB yana buɗewa don ingantacciyar isar da magunguna, sakin neoantigen da rigakafin rigakafi shine yuwuwar canjin wasa a cikin filinmu wanda zai taimaka mana haɓaka kan zaɓuɓɓukan jiyya na yanzu da ake samu ga waɗannan marasa lafiya."

Liquid biopsy wata sabuwar hanya ce don subtyping na ciwon daji ba tare da ɓarna ba, zaɓin magani, lura da saura cuta, gano farkon gano masu amsa jiyya tare da waɗanda ba su amsa ba, da kimanta ci gaban ƙari tare da haɓakar haɓaka.

"Duk da ci gaba mai ban mamaki a wasu cututtukan daji, biopsy na ruwa yana da iyakacin nasara a cikin ciwace-ciwacen kwakwalwa saboda kasancewar shingen kwakwalwar jini, wanda ke iyakance gano sigina a cikin jini," in ji Dr. Achal Singh Achrol, MD, FAANS, Babban Jami'in Lafiya. da Insightec. "Binciken na yau da kullun da na ɗan adam na farko sun nuna cewa ƙananan ƙarfin da aka mayar da hankali kan duban dan tayi (LIFU) na iya haɓaka haɓakar shingen kwakwalwar jini a ɗan lokaci kuma ya ba da izinin keɓantattun ƙwayoyin cuta na yanki don ba da damar biopsy na ruwa mara ƙarfi a cikin ciwan kwakwalwa. Wannan gwaji mai mahimmanci na asibiti zai bincika a karon farko fa'idar asibiti ga wannan hanyar a matsayin sabon sabon zaɓi ga ƙwayoyin cuta masu ɓarna neurosurgical."

"Insightec ya ci gaba da yin haɗin gwiwa tare da manyan masu bincike don ci gaba da yin amfani da maganin acoustic a cikin kwakwalwa," in ji Maurice R. Ferré, MD, Insightec Shugaba da Shugaban Hukumar. "Wannan aikin yana mai da hankali kan buɗe shingen kwakwalwar jini cikin aminci ta hanyar amfani da ƙarancin kuzarin ƙararrawa kuma yana da yuwuwar canza hanyoyin warkewa da bincike na yanzu don yanayi kamar kansar ƙwaƙwalwa. Babban burinmu shine, kamar koyaushe, don tasiri ga rayuwar masu haƙuri. "

An riga an amince da na'urar Exablate Neuro FDA don kula da Mahimmin Tremor da Cutar Cutar Parkinson. A ƙarshen 2021 akwai cibiyoyin kiwon lafiya 42 a cikin Amurka da ke amfani da na'urar Insightec Exablate Neuro don kula da marasa lafiya da waɗannan yanayin. Tsarin Insightec Exablate Prostate tsarin ya sami izini na FDA 510K don kawar da nama na prostate tare da tsananin Mayar da hankali Ultrasound.

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Avatar na Linda Hohnholz

Linda Hohnholz

Edita a shugaba don eTurboNews bisa ga eTN HQ.

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