Medtronic plc has reported the launch of the Inpen integrated with real-time Guardian Connect continuous glucose monitoring (CGM) data. Inpen is the first U.S. FDA-cleared smart insulin pen on the market for people on multiple daily injections (MDI). With this integrated system, users will have real-time glucose readings alongside insulin dose information, giving them what they need to manage their diabetes in one view. Read More
Dialysis maker Outset Medical Inc. tallied $13.8 million in revenue for the third quarter of 2020, up 423% from the prior year period – in its quarter as a publicly traded company. Of that, $10.8 million was product revenue, buoyed by COVID-19 tailwinds that drove demand for Tablo portable dialysis systems. Read More
The competitive din in the vocal sound diagnostic space rose to new levels as Sonde Health Inc. launched a developer portal to enable other companies to incorporate its vocal biomarker-based health check technology into their apps. Sonde joins a growing number of companies and academic labs around the world talking up the ability of voice recordings to detect a surprising range of diseases. Read More
Regulation of the digital health space is in some respects fundamentally different from traditional hardware medical devices, a fact that was highlighted during a Nov. 12 webinar hosted by the U.S. FDA. Nonetheless, several participants in the webinar made the point that the twin problems of coverage and reimbursement are critical issues for digital health as well, a problem that some see as requiring more collaboration between the FDA and the Centers for Medicare & Medicaid Services (CMS). Read More
Researchers at Yale University have described what they have called a “data sanitization tool,” enabling them to strip personal identifiers out of functional genomics data while preserving their usefulness for research. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA eyes grant of license for spectrometer for SARS; HQO eyes TAVI/TAVR for low-risk patients; ACLA says testing capacity beginning to strain. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Angiodynamics, Castle Biosciences, Integrity Implants. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied DNA Sciences, Avicenna.AI, Becton Dickinson, Canon Medical Systems, Cb Scientific, Cubex, Decision Diagnostics, Djo, Fedoc, Isohelix, Mindray North America, Perspectum, Precision Genetics, Stryker, Tidepool, Virusight Diagnostic, Vizient, Zoll Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioelectronics, Perkinelmer, Spiderwort, Wren Laboratories. Read More
Keeping you up to date on recent developments in diagnostics, including: Predicting schizophrenia; Functional analysis complements sequencing; Early screening for cognitive decline; Rapid test highly accurate for PJI infections. Read More