Amsterdam-based Royal Philips NV has launched a five-day, wearable biosensor patch that monitors respiratory and heart rates once every minute, as well as assesses contextual information such as posture, activity level and ambulation. The wearable, disposable patch, dubbed the Philips Biosensor BX100, has received FDA clearance and a CE mark and is intended for use in lower acuity hospital care.
Although many companies have experienced struggles during the COVID-19 pandemic, Brisbane, Australia, and Carlsbad, Calif.-based Impedimed Ltd. has seen success with Sozo, the company’s digital health platform. Indeed, the company has as one of its priorities helping patients with lymphedema with the platform, which is a noninvasive bioimpedance spectroscopy device.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4DMedical, Bardy Diagnostics, Beyond Air, Merit Medical, Orteq Sports Medicine, Philips, Smart Medical Systems, United Imaging.
Proscia Inc., a Philadelphia-based company that focuses on artificial intelligence (AI)-enabled digital pathology solutions, recently made the Concentriq Dx digital pathology software available for use in reviewing and reporting of digital pathology slides in the U.S. during the COVID-19 pandemic.
LONDON – Heart disease is now known to be both a cause and an effect of serious COVID-19 infection, with more than 1 in 10 patients who have underlying cardiac conditions being killed by the virus, while others with no previous record of cardiovascular problems are suffering significant COVID-19 induced weakening of their hearts.
Deep Lens Inc. has integrated molecular data parsing and management technology into its Viper clinical trial screening and enrollment platform, enabling automated matching of patients with eligible genetic profiles to clinical trials. The Columbus, Ohio-based company licensed the proprietary technology from the University of Miami.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abiomed, Axonics, Castle Biosciences, Cerapedics, Eyenuk, Limflow, Medasense.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 1drop, Agilent, Edwards, Everlywell, Fulgent Genetics, Zebra Medical Vision.
Except for breakthrough devices and qualifying infectious disease drugs, the footwork for getting Medicare's new technology add-on payment (NTAP) can be more challenging than that needed to win FDA approval. It could be even tougher for products that use artificial intelligence (AI) or that follow a subscription model for pricing.
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