In this episode, Medtech Insight regulatory reporter Hannah Daniel and managing editor Amanda Maxwell speak to Marcel Gehrung, co-founder and CEO of Cyted. Marcel discussed global regulations for Cyted’s product Endosign, and how the company leveraged the product’s flexibility to gain approval and reach markets as efficiently as possible. We also talk about different market authorization requirements in the EU, UK, and US, and the use of AI in healthcare spaces in the UK.
Members of AdvaMed’s digital health tech board of directors discussed the organization’s efforts to aid the Trump administration and Congress in answering AI policy questions, especially as companies deal with mounting regulatory uncertainty.
Abbott has also added new customization options to enhance user comfort and discretion. These include a “silent mode” feature for FreeStyle Libre 3 systems, allowing users to mute glucose alarms for up to six hours – a useful option during meetings, sleep, or other moments where audio alerts may be disruptive.
Cambridge-based startup Mursla Bio's liquid biopsy test EvoLiver uses extracellular vesicles to detect hepatocellular carcinoma (HCC) in high-risk cirrhotic patients. Medtech Insight sat down with with Mursla Bio CEO Pierre Arsène.
Built on Click’s AI-enabled platform, CT-132 delivers a 12-week behavioral intervention program rooted in multiple evidence-based techniques, including cognitive behavioral therapy (CBT) and bio-behavioral approaches. The goal: reduce brain hypersensitivity and enhance patients’ resilience to migraine triggers.
Abbott has also added new customization options to enhance user comfort and discretion. These include a “silent mode” feature for FreeStyle Libre 3 systems, allowing users to mute glucose alarms for up to six hours – a useful option during meetings, sleep, or other moments where audio alerts may be disruptive.
Cambridge-based startup Mursla Bio's liquid biopsy test EvoLiver uses extracellular vesicles to detect hepatocellular carcinoma (HCC) in high-risk cirrhotic patients. Medtech Insight sat down with with Mursla Bio CEO Pierre Arsène.
Biolinq plans to use the proceeds of its new venture funding to support US FDA de novo review, automation engineering and commercialization efforts with partners, CEO Rich Yang told Medtech Insight.