The FDA unloaded on Neurofield Inc. for misbranding of its products, which are only approved as class II biofeedback devices, as neurostimulation and electroencephalogram (EEG) signal processing devices. The warning letter called on “Neurofield to cease any activities that result in the adulteration or misbranding of the Neurofield X3000/X3000 Plus, Neurofield Q21, Neurofield64 and Neurofield EEG.”
China’s NMPA has approved 12 antigen self-test kits between March 12 and 16 amid COVID-19 outbreaks in many parts of the country. The regulator claims that there will soon be more test kits approved. The number of COVID-19 infectious cases in China surged rapidly over the first half of March.
Woebot Labs Inc. secured a $9.5 million investment from Leaps by Bayer, the impact investment arm of Bayer AG, to speed development of its artificial intelligence (AI)-enhanced behavioral health platform and digital therapeutics. The new infusion tops up Woebots fundraising, bringing its total to date to $123.5 million. The Woebot investment marks Leaps by Bayer’s first foray into mental health.
Google Health is expanding the reach of its Care Studio technology to clinical software company Medical Information Technology Inc. (Meditech). The companies reported a partnership at HIMSS 2022 to integrate search functionalities from the Google product suite within Westwood, Mass.-based Meditech's web-based Expanse electronic health record (EHR). The aim is to combine data from different sources into a standard format and offer clinicians a full ‘holistic’ view of patient records.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Orthofix Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alivecor, Alphabet, Bearpac Medical, Biocircuit Technologies, Brighter, Cardiovascular Systems, GE Healthcare, IBA, Lumea, Mimedx, Nucleix, Smithfield Bioscience, Terran, Verily, Vizient, Woundgenex.
By using roughly 400 data points, from molecular to physical fitness, researchers have gained new insights into how organs such as the heart vs. the skin, and systems such as the immune and metabolic systems, age at different rates within individuals.