Glucotrack files for IDE
Glucotrack is preparing an IDE filing with the US FDA in early Q2 2026 for its implantable continuous blood glucose monitor after feasibility work in Australia and Brazil. (manilatimes.net)
Glucotrack issued a detailed company press release summarizing its 2025 clinical and operational milestones on March 27, 2026. (glucotrack.com) The company completed a first‑in‑human, in‑hospital study at Instituto do Coração (InCor) in São Paulo that enrolled 10 adults with Type 1 or Type 2 diabetes between Dec. 13, 2024 and Jan. 31, 2025. (investing.com) Final analysis from that Brazil study reported a mean absolute relative difference (MARD) of 7.7% across matched points, a 99% data‑capture rate, and no device‑ or procedure‑related serious adverse events. (rttnews.com) A follow‑up feasibility trial began at the Diabetes Technology Research Group of St Vincent’s Hospital Melbourne in July 2025, with the protocol designed to enroll up to 30 participants and to feed protocol and product learnings into the next clinical stage. (biospace.com) Glucotrack describes its CBGM as a fully implantable system with no external on‑body component, three‑year sensor longevity and minimal calibration requirements, details highlighted in its ATTD poster and follow‑up coverage. (glucotrack.com) (mddionline.com) The company says it has built a dual‑source U.S. manufacturing approach with two qualified contract partners, strengthened its board and advisory teams with industry veterans from Dexcom/Abbott/Senseonics/Medtronic, and executed a $4.0 million at‑the‑market private placement in December 2025; shares reacted in after‑market trading on March 27, 2026, rising roughly 47.6% in coverage by Benzinga. (glucotrack.com) (stockanalysis.com) (benzinga.com)
