Thirteen months after establishing a strategic alliance to distribute 7D Surgical Inc.’s machine-vision, image-guided surgery platform, Seaspine Holdings Corp. (NASDAQ:SPNE) signed an agreement to acquire the Toronto-based company. 7D Surgical shareholders will receive $27.5 million in cash plus $82.5 million in Seaspine stock and will hold approximately 13% of Seaspine’s shares at completion. The deal is expected to close in the second quarter of 2021. Read More
Insulet Corp. reported positive results from a pivotal trial of its Omnipod 5 automated insulin delivery system for patients with type 1 diabetes. The tubeless, wearable insulin delivery system lowered hemoglobin A1c (HbA1c) – a critical diabetes measure – in children, adolescents, and adults, and improved the time that patients were in the target blood glucose range. The data was presented at ENDO 2021, the Endocrine Society’s annual meeting, which was held virtually this year. Read More
Although artificial intelligence (AI) seems to be making only incremental headway in the world of medical technology, Brainscope Co. Inc., continues to advance its AI offerings with the launch of the Concussion Index (CI). This algorithm, used with the company’s disposable headset, has been demonstrated to reduce the need for cranial CT scans by 30%, making this a double win for patients and for health care spending in the U.S. Read More
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released three final guidances on its expectations on clinical performance requirements and risk mitigation for in vitro diagnostic (IVD) self-tests. The guidances outline clinical performance requirements and key risks that must be mitigated for IVDs to be used as self-tests for seasonal influenza; hepatitis B virus (HBV) and hepatitis C virus (HCV); and chlamydia, gonorrhea; and syphilis. Read More
CAJICA, Colombia – The COVID-19 pandemic has exposed the weaknesses of Mexico’s techno-vigilance system, along with a chronic lack of reporting of inventories and adverse effects related to medical devices in use. These weaknesses were exposed during previous pandemics but the country’s antiquated tracking and reporting system has not changed. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Electrocore, Coherent, Fusion Robotics, Lumentum, Oxford Biodynamics, Predictmedix, Silvert Médical, Smartcone Technologies, Symp2pass, Thermo Fisher Scientific, Todos Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainscope, Optellum, Ortho Clinical Diagnostics, Shape Memory Medical. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIJ seeks feedback on apps for mental health. Read More
Keeping you up to date on recent developments in oncology, including: New technique may enable electrons in cancer radiotherapy; Universal initiates study of cell-free DNA blood test; Concerns linger about cardiovascular risk factors in conjunction with cancer treatment. Read More
