Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bigfoot Biomedical, Conformis, Edge Surgical, Inova Diagnostics, Ortho Development, Orthofix, Think Surgical.
LONDON – Cumulus Neuroscience Ltd. has raised £6 million (US$8.3 million) to advance development of its home use wearable headset for tracking response to treatment in clinical trials in psychiatric disorders and neurodegenerative diseases, including Alzheimer’s.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aegis Spine, Appriss Health, Auxo Medical, Biointellisense, Cleardata, Cryoport, Labconnect, Life Spine, Patientping, Triumvira Immunologics.
Medtronic plc has launched Careguidepro, its first patient-focused digital tool for spinal cord stimulation. The mobile app and online portal enables providers to better manage patients’ pain relief with real-time feedback and data.
The FDA’s May 4 webinar on patient data generated over the course of the product life cycle covered a number of topics, including the use of social media as a source of real-world evidence (RWE). The FDA’s Anne Hammer said, however, that while social media engagement has exploded over the past couple of decades, issues such as data duplication and verifiability will have to be resolved before patient engagement via social media can be relied upon as a source of RWE for regulatory purposes.