I-CoapTech, Inc, inkampani yesixhobo sonyango egxile ekunikezeni izisombululo zoguqulo zotyando oluncinci, ibhengezwe namhlanje ukuba ifumene imvume yoXolo lweSixhobo soPhando (IDE) kuLawulo lokuTya kunye neziyobisi (FDA) ukuqalisa uvavanyo lweklinikhi kwi-PUMA- I-G Peds System, isixhobo esiyilelwe ukunika indlela ekhuselekileyo nesebenzayo yokubeka iityhubhu zokuxheshisela ebantwaneni.
I-PUMA System™ luhlobo olutsha lwezixhobo ezihlasela kancinci, evumela iinkqubo ze-ultrasound kumalungu omzimba angenanto apho ngaphambili bekungenakwenzeka okanye kungakhuselekanga ukwenza oko. I-PUMA-G Peds System iphuhliswa ukuvumela ukubekwa kwe-ultrasound-based of gastrostomy tubes kwizigulane zabantwana njengenye indlela ye-endoscopic yendabuko, i-fluoroscopic kunye neenkqubo ezivulekileyo zotyando. Iinkqubo ze-Endoscopic azikwazi "ukubona" kwizicubu ezinokuthi zibangele umonakalo womzimba kunye nezinye iingxaki ezikhoyo ezinxulumene nobukhulu obukhulu bee-endoscopes ezinxulumene nabantwana abancinci. Iinkqubo zeFluoroscopic zifuna ukusetyenziswa kwemitha ye-ionizing ebonisa umngcipheko omkhulu womhlaza wexesha elizayo kubantwana abancinci. I-PUMA-G Peds System isebenzisa i-ultrasound ukujonga izicubu kunye nezitho ngexesha langempela ngaphandle kwe-ionizing radiation.
“Siyavuya kuba i-FDA inike le-IDE, isivumela ukuba siqalise isifundo kunye neziza zethu ezikumgangatho wehlabathi. Ulwamkelo lububungqina bomsebenzi wethu owomeleleyo wangaphambili kunye nokubanakho kwePUMA-G Peds System ukuba nefuthe kakhulu kukhathalelo lwabantwana, utshilo uJack Kent, iGosa eliyiNtloko lezoRhwebo eCoapTech. Ulingo lwe-multicenter non-inferiority kunye neqela elihambelanayo lolawulo lokubuyela emva liyinxalenye yesibonelelo se-NIH SBIR kwaye liya kuqalisa ukubhalisa izigulane kule ntwasahlobo kwiSibhedlele saBantwana saseFiladelphia, iZiko leSizwe lezoNyango laBantwana, kunye neSibhedlele saseNewYork-Presbyterian.
I-CoapTech yaphuma kwiYunivesithi yaseMaryland, eBaltimore (UMB) apho iteknoloji yaphuhliswa khona. Ingalo yokudlulisa itekhnoloji ye-UMB, uM Ventures, eBaltimore, nayo ibonelele ngotyalo-mali oluthe ngqo kwinkampani.
"Lo ngumdlalo obalulekileyo kwiinzame zeCoapTech zokuzisa ukuthengisa inguqulelo yabantwana yetekhnoloji yeqonga lePUMA-G," utshilo uPhil Robilotto, uSekela Mongameli oDityanisiweyo weOfisi yoTshintsho lweTekhnoloji e-UMB, kunye noMlawuli we-UM Ventures, eBaltimore. "Sijonge phambili kulingo lwekliniki kwaye sibone ukuba yintoni elandelayo kwi-CoapTech."
INTO ONOKUYITHATHA KWELI NQAKU:
- I-CoapTech, Inc, inkampani yesixhobo sonyango egxile ekunikezeni izisombululo zoguqulo zotyando oluncinci, ibhengezwe namhlanje ukuba ifumene imvume yoXolo lweSixhobo soPhando (IDE) kuLawulo lokuTya kunye neziyobisi (FDA) ukuqalisa uvavanyo lweklinikhi kwi-PUMA- I-G Peds System, isixhobo esiyilelwe ukunika indlela ekhuselekileyo nesebenzayo yokubeka iityhubhu zokuxheshisela ebantwaneni.
- I-PUMA System™ luhlobo olutsha lwezixhobo ezihlasela kancinci, ezivumela iinkqubo ze-ultrasound kumalungu omzimba angenanto apho ngaphambili bekungenakwenzeka okanye kungakhuselekanga ukwenza oko.
- Ulwamkelo lububungqina bomsebenzi wethu owomeleleyo wangaphambili kunye nokubakho kwePUMA-G Peds System ukuba nefuthe elikhulu kukhathalelo lwabantwana,”.