Medtech Insight spoke to two CEOs of start-ups working on graphene-based devices to learn more about how regulation and fears over nanomaterials’ side effects affect device development.
New companies have been attempting to exploit graphene’s properties for medtech because it offers unrivalled conductivity at body temperature, flexibility, and most importantly, biocompatibility.
Since first being isolated by professors Andre Geim and Kostya Novoselov in 2004 at the University of Manchester, graphene has...
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Viome Life Sciences accelerates its push into clinical diagnostics with studies in colorectal cancer and a major partnership with Microsoft to scale its molecular data analysis platform. Viome leverages RNA analysis and AI to detect disease at the molecular level and personalize preventive health.
Delfi Diagnostics is preparing for pivotal trial results that could support FDA approval and reimbursement for its fragmentomics-based lung cancer screening test. Early data suggest strong potential to improve screening uptake and expand access to early detection.
After rolling out its hair-based autism diagnostic across the US, LinusBio is expanding into Japan and testing its “molecular movie” technology for ALS and other neurological disorders, aiming to deliver the first objective biomarkers in pediatric and neuropsychiatric care.
US FDA inspections of three Philips manufacturing sites earlier this year resulted in a September warning letter that claimed the company was not in conformity with current good manufacturing practices. Philips says it is addressing the agency’s concerns and working to enhance its quality systems.
The neuromodulation space is quickly filling with well-funded companies that have demonstrated early signs of success. However, with strategics seemingly unwilling to spend on novel technologies and pharma desperate to maintain its foothold in CNS, these companies will face many challenges.
After rolling out its hair-based autism diagnostic across the US, LinusBio is expanding into Japan and testing its “molecular movie” technology for ALS and other neurological disorders, aiming to deliver the first objective biomarkers in pediatric and neuropsychiatric care.
US FDA inspections of three Philips manufacturing sites earlier this year resulted in a September warning letter that claimed the company was not in conformity with current good manufacturing practices. Philips says it is addressing the agency’s concerns and working to enhance its quality systems.
