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US FDA clearance for MicroBlateT Fine device
US FDA clearance for MicroBlateT Fine device.
About this update from Creo Medical Group Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 8519D\n Creo Medical Group PLC\n 02 November 2020\n \n \n \n \n \n \n \n The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (\"MAR\"). Upon the publication of this announcement via Regulatory Information Service (\"RIS\"), this inside information is now considered to be in the public domain.\n \n \n \n \n \n Creo Medical Group plc\n \n \n (\"Creo\" or the \"Company\")\n \n \n \n \n \n \n US FDA clearance for \n \n \n MicroBlate\n \n \n ™\n \n \n Fine\n \n devic\n e\n \n \n \n \n \n Creo Medical Group plc (AIM: CREO), the medical device company focused on the emerging field of surgical endoscopy, announces that it has received 510(k) clearance from the US \n Food & Drug Administration ('FDA') for its tissue ablation device MicroBlate\n \n ™\n \n \n Fine\n \n .\n \n \n \n \n \n This is the third device to gain FDA regulatory clearance within Creo's portfolio of flexible endoscopy devices for the gastrointestinal ('GI') market\n alongside SlypSeal™ Flex and Speedboat™ Inject. The range is designed to be used with the CROMA Advanced Energy Platform, powered by Kamaptive™ full-spectrum adaptive technology, a seamless, intuitive integration of multi-modal energy sources, optimised to adapt to the tissue effect required for different procedures such as resection, dissection, coagulation and ablation of tissue.\n \n \n \n \n \n \n About MicroBlate™\n \n \n \n \n \n Fine\n \n \n \n \n \n \n Creo's MicroBlate™ tissue ablation technology utilises Creo's very high frequency microwave energy allowing physicians to precisely ablate diseased tissue in multiple organ types and many different clinical access methods. MicroBlate™\n \n \n \n \n Fine,\n \n believed to be the smallest diameter MW ablation needle antenna in the world, has\n the same dimensions as a standard biopsy needle which, when used with typical ultrasound navigation tools, enables improved access to and the ablation of a wide range of organs (such as pancreas, liver, kidney, lung and muscle) during open, laparoscopic, percutaneous and endoscopic procedures\n .\n \n \n \n \n \n Creo's \n \n Speedboat™Inject\n \n , \n already CE marked and with FDA...