I-Photocure ASA, iNkampani yeCancer Cancer, ibhengeze ukuba i-US Food and Drug Administration (i-FDA) ivume inkqubo entsha kunye nephuculweyo ye-Blue Light ukuba isetyenziswe kunye nemveliso ye-Photocure ye-Cysview® kwiinkqubo ze-Blue Light Cystoscopy (BLC®) zokufunyanwa kwe-NMIBC *. Yenziwe kwaye kungekudala iza kuthengiswa ngu-KARL STORZ Endoscopy-America, Inc. (KARL STORZ), inkqubo entsha yokukhanya okuBlue ivunyiwe ukuba isetyenziswe kwiinkqubo ezifuna i-cystoscopy eqinile. Imvume ye-FDA inikwe i-KARL STORZ nge-4 kaFebruwari 2022.
"Ukuvunywa okuyimpumelelo kwe-FDA ziindaba ezimnandi kuluntu lomhlaza wesinyi e-US," utshilo uGeoffrey Coy, uSekela Mongameli kunye noMphathi Jikelele, kuMntla Melika kwiFotocure. “Kukhathalelo lwempilo, ukusungula okuthe gqolo kobugcisa kubalulekile, kwaye silindele ukuba le nkqubo intsha, iphuculweyo ye-BLC iya kuzalisekisa ulindelo lwabathengi bethu ekuphuculeni amava eBlue Light. Inkqubo entsha sisizukulwana esilandelayo kwaye ibandakanya iimpawu ezisebenzayo ukwenza iteknoloji isebenziseke ngakumbi. Sijonge phambili ekwandiseni ukusetyenziswa kwe-BLC ngeCysview®,” uqukumbele watsho uGeoffrey Coy.
"Kwi-KARL STORZ, sizimisele ekuncedeni abathengi bethu ukuba banikezele ngononophelo oluphezulu, kwaye sikholelwa ukuba inkqubo yethu entsha ye-Blue Light ibonisa oku kuzibophelela," kusho uMichael Lyman, uMlawuli oyiNtloko, uThengiso kunye neNtengiso, i-Urology kunye ne-Gynecology, i-KARL STORZ Endoscopy. -Amerika. "UkuKhanya okuBlue okutsha okuMandla nguSaphira® kuya kusivumela ukuba sisebenzele iimfuno zabathengi bethu, sibonelela ngokubonwa kwinqanaba elilandelayo ukwenza izisombululo ezifanelekileyo kwiinkqubo ze-urological kwizigulana ezinoMhlaza weSinyi ongenazihlunu kunye nokuqhubeka nokusebenzisana kwethu neqela lePhotocure. ukwenza i-BLC ekumgangatho ophezulu ifumaneke kwizigulana ezininzi e-US”.
I-Photocure ilindele ukwazisa abachaphazelekayo malunga nokuqaliswa kwenkqubo entsha ye-Blue Light njengoko i-KARL STORZ inikezela ngolwazi olungakumbi malunga nemveliso kunye nezicwangciso zayo zokuqalisa.
INTO ONOKUYITHATHA KWELI NQAKU:
- “The New Blue Light Powered by Saphira® will allow us to serve the needs of our customers, providing next-level visualization to enable the right solutions for urological procedures in patients with Non-Muscle Invasive Bladder Cancer and continue our collaboration with the Photocure team to make high-quality BLC available to more patients in the U.
- Food and Drug Administration (FDA) approved of a new and improved Blue Light system to be used with Photocure’s Cysview® product in Blue Light Cystoscopy (BLC®) procedures for the detection of NMIBC*.
- I-Photocure ilindele ukwazisa abachaphazelekayo malunga nokuqaliswa kwenkqubo entsha ye-Blue Light njengoko i-KARL STORZ inikezela ngolwazi olungakumbi malunga nemveliso kunye nezicwangciso zayo zokuqalisa.
