Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Biocode, Cae, Candela, Enexor Health, Foundation Medicine, Tandem Diabetes Care.
Keeping you up to date on recent developments in orthopedics, including: Osteoporosis treatment also may protect against pneumonia; Study finds similar short-term outcomes after common MI spine procedures; New biomaterial has potential to repair damaged bone with lower risk of inflammation; Diabetics face greater risk of bone fractures.
A wireless system to monitor mothers in labor and their fetuses has been introduced by Royal Philips NV in the U.S. Known as the Avalon CL Fetal and Maternal Pod and Patch, it is commercialized under recently updated guidance from the U.S. FDA. The Amsterdam-based company is continuing to pursue a standard 510(k) clearance for the system, which is marketed in European countries, Australia, New Zealand and Singapore.
Clew Medical Ltd., of Netanya, Israel, has secured an emergency use authorization (EUA) from the U.S. FDA for its ClewICU system for use with COVID-19 patients in intensive care units (ICUs). The screening system is a standalone software as a medical device product that uses vital signs, laboratory data, medications and other information to assess the likelihood a patient has been infected with SARS-CoV-2, the virus that causes COVID-19.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bimini Health Tech, Binx Health, Cardinal Health, Copan, Cymedica Orthopedics, Debiotech, Exthera, Genmark Diagnostics, Healeon Medical, Healgen, Hill-Rom, Inovalon, Kardiac Devices, Keystone Heart, Kore, MD Anderson Cancer Center, Menarini, Neokidney, Ngmedical, Nicoya, Philips, Puritan, Second Sight, Svenska Labfab, Trialspark, Venus Medtech, The Wound Pros.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Endologix, Klarity, Supernus, United Therapeutics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clew, Guard Medical, Infinity, Inmode, Smith+Nephew.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott, Exact Sciences, Halo Diagnostics, Lucence, Medtronic, Sequana Medical.
RSS
