Ua ʻae ʻo FDA i ka hoʻāʻo ʻana o HistoSonics IDE no ka hoʻomaʻamaʻa kani kani

Hoʻokumu ʻo HistoSonics i hoʻokumu ʻia ma Minneapolis i kā lākou ʻōnaehana Edison e hoʻopaʻa a pepehi i nā maʻi maʻi maʻi maʻi mua.Hana ʻo ia me ka ʻole invasive, me ka ʻoki ʻole a i ʻole nā ​​nila.Ua hoʻohana ʻo Edison i kahi lāʻau kani kani hou i kapa ʻia ʻo histology.
Kākoʻo ʻia ʻo HistoSonics e kekahi o nā mea pāʻani nui i ka ʻoihana ʻenehana lapaʻau.I Mei 2022, ua komo ka hui i kahi ʻaelike me GE HealthCare e hoʻohana i kāna ʻenehana kiʻi ultrasound e hāʻawi i kahi ʻano hou o ka leo beam therapy.I Kekemapa 2022, ua hoʻonui ʻo HistoSonics i $85 miliona i kahi pōʻai kālā i alakaʻi ʻia e Johnson & Johnson Innovation.
Ua ʻōlelo ka hui ʻo ka ʻae ʻana o FDA i ka noiʻi Hope4Kidney e pili ana i nā ʻike hou loa mai ka noiʻi Hope4Liver.Ua hoʻokō nā hoʻokolohua ʻelua i kā lākou palekana mua a me ka hopena hopena i ka huli ʻana i nā ʻōpū o ka ate.
"He mea koʻikoʻi kēia ʻae ʻia no kā mākou hui ʻoiai mākou e hoʻomau nei i ka hoʻonui ʻana i ka hoʻohana ʻana i ka ʻenehana slicing tissue a me kāna mau pono kūpono i ka mālama ʻana i nā maʻi e pili ana i ke ola o nā poʻe he nui," wahi a Mike Blue, Pelekikena a Luna Nui o HistoSonics.Ua hauʻoli mākou e hoʻonui i kā mākou ʻike.ʻO ka huli ʻana a me ka hoʻomaʻamaʻa kūleʻa i loko o ke ake me ka hoʻohana ʻana i kā mākou paepae Edison holomua, kahi e hui pū ai i nā kiʻi kiʻi kiʻi a me nā hiki ke hoʻopaʻa ʻia me ka nānā ʻana i ka manawa maoli.
ʻO nā lāʻau lapaʻau i kēia manawa no nā maʻi maʻi ʻaʻai me ka nephrectomy hapa a me ka ablation thermal, wahi a HistoSoncis.Hōʻike kēia mau kaʻina hana invasive i ke koko a me nā hoʻopiʻi infectious i hiki ke pale ʻia me ka biopsy tissue non-invasive, wahi a ka hui.
Hiki i kēia lāʻau lapaʻau ke hoʻopau i ka ʻiʻo i hoʻopaʻa ʻia me ka ʻole o ka hōʻino ʻana i ka ʻiʻo ʻiʻo ʻaʻole i hoʻopaʻa ʻia.Hiki ke mālama ʻia ka hana o ka ʻōnaehana urinary o nā puʻupaʻa i ke ʻano o ka luku ʻana i nā cell i nā ʻāpana kiko.
Hoʻohana ʻo HistoSonics Image Guided Sound Beam Therapy i ke kiʻi kiʻi kiʻi a me ka ʻenehana sensor patented.Hoʻohana ka lāʻau lapaʻau i ka ikehu acoustic i hoʻopaʻa ʻia e hana i ka cavitation acoustic i hoʻopaʻa ʻia e hoʻopau me ka hoʻoheheʻe ʻana i ka ʻiʻo o ka ate ma kahi pae subcellular.
Hiki i ka paepae ke hāʻawi i ka hoʻihoʻi wikiwiki a me ka lawe ʻana, a me ka hiki ke nānā aku, wahi a ka hui.
ʻAʻole kūʻai ʻia ʻo Edison i kēia manawa, e kali ana i ka loiloi FDA no nā hōʻailona kiko o ka ate.Manaʻo ka ʻoihana e kōkua nā hoʻokolohua e hiki mai ana i ka hoʻonui ʻana i nā hōʻailona no ka ʻiʻo ʻāʻī.
"ʻO ka noi kūpono e pili ana i ke kīpē, no ka mea, ua like ke ʻano o ka maʻi maʻi i ka ate ma ke ʻano o ke kaʻina hana a me ka anatomical noʻonoʻo, a ua hoʻolālā pono ʻia ʻo Edison e mālama i kekahi ʻāpana o ka ʻōpū ma ke ʻano he hoʻomaka," wahi a Blue."Eia kekahi, ke kiʻekiʻe nei ka maʻi o ka maʻi kīkī, a he nui nā maʻi ma lalo o ka nānā ʻana a i ʻole ke kali ʻana."
Waiho ʻia ma lalo: Nā hoʻāʻo maʻi, 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.
Kuleana kope © 2023 · WTWH Media LLC a me kona mau mea laikini.Ua mālama ʻia nā kuleana āpau.ʻAʻole hiki ke hana hou ʻia nā mea ma kēia pūnaewele, hāʻawi ʻia, hoʻouna ʻia, hūnā ʻia a hoʻohana ʻia ʻē aʻe koe wale nō me ka ʻae i kākau mua ʻia e WTWH Media.


Ka manawa hoʻouna: Feb-14-2023