Widespread testing is going to be key to safely reopening businesses and global economies in the current pandemic. To that end, Kahala Biosciences LLC, an Irvine, Calif.-based testing and tracking startup, and its technology partner, Rymedi Inc., of Greenville, S.C., have launched the Adiona COVID-19 antibody testing platform, combining antibody testing with a blockchain-enabled smartphone app to increase predictability and traceability of potential outbreaks. Read More
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. Read More
The number of tests of various types for the SARS-CoV-2 virus are still growing, but the emergency use authorization (EUA) program is not the only option for developers. Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiology, said on the agency’s May 27 town hall that the agency would like to see test developers file for a 510(k) for their tests when the data are sufficient to support an application, adding that any such clearances will not affect the U.S. FDA’s interest in keeping plenty of similar tests on the market via the EUA mechanism. Read More
Variants in the APOE gene are the strongest genetic risk factor for developing Alzheimer’s disease (AD). Now, researchers at Rockefeller University have demonstrated that APOE variants also affected the risk of progression and metastasis as well as the response to immunotherapy, in melanoma. Read More
KARACHI, Pakistan – Beyond stepping up manufacturing of the medical devices it needs to fight COVID-19, Pakistan is using technology platforms to reach out to a large diaspora for help. The country is taking steps to leverage limited resources through a more comprehensive system of telehealth applications that allow for faster self-diagnosis and make it possible to tap into the expertise of Pakistani doctors. Read More
New hires and promotions in the med-tech industry, including: Axim Biotechnologies, Centricity Vision, Flagship Biosciences, Neuromod Devices, RTI Surgical Holdings. Read More
Med-tech firms raising money in public or private financings, including: 1Life Healthcare, Inari Medical, Magnolia Medical Technologies, Siren, Stryker, Wright Medical. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Altapure, Biodesix, Biotronik, Clinical Genomics, Procept Biorobotics, Roche. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Centinel Spine, Zionexa. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Nantong Egens Biotechnology, Ntbio Diagnostics. Read More
Keeping you up to date on recent developments in orthopedics, including: Cell 'pores' discovery gives hope to millions of brain and spinal cord injury patients; Little skates could hold the key to cartilage therapy in humans; Spinal cord injury increases risk for mental health disorders. Read More
