Stony Brook Medicine has launched an FDA-approved, randomized investigational new drug (IND) trial to determine whether plasma from people who have recovered from COVID-19 can aid in the recovery of patients currently fighting the disease. Chembio Diagnostics Inc.'s COVID-19 rapid serological point-of-care test will be used to identify potential plasma donors. Read More
LONDON – These are hardly times for a fanfare, but this month saw the unveiling of a new name in bioprocessing, following the formal closing of the $21.4 billion sale of GE Healthcare’s Life Sciences to Danaher Corp. The business, now renamed Cytiva, has turnover of $3.3 billion, nearly 7,000 employees and operations in 40 countries. More than 75% of FDA-approved biologic drugs use its products in their manufacture. Read More
The U.S. FDA’s routine guidance agenda may be badly disrupted by the COVID-19 outbreak, but the agency continues to pump out guidances and emergency use authorizations (EUAs) directed to the pandemic. While the FDA has included only one serological test under the diagnostic EUA paradigm, Rep. Diana DeGette penned a letter inquiring into when the agency intends to move more decisively on serological tests, arguing that the absence of action on this front endangers the nation’s economic health as well as the public’s health. Read More
The human body constantly assaults medical devices that are implanted within it. The traditional solution to that has been to encase them in titanium. But that’s not the best option in the brain, where it remains difficult to place a high number of electrodes without damaging the brain, while protecting the device from long-term damage. Read More
Informed Data Systems Inc., doing business as One Drop, purchased the assets and intellectual property of Sano Intelligence Inc. for an undisclosed amount. San Francisco-based Sano has been developing a wearable continuous glucose sensor that enables users to track blood glucose levels and other blood chemistry via a smart phone app for nearly a decade. One Drop will integrate the stick-on device into its personalized digital care program for diabetics and people with other chronic conditions. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apollo Endosurgery, Atricure, Eos imaging, Kolon Tissuegene, Piranha Medical, Pluristem, Predictive Biotech, Predictive Technology, Rethink My Health, Scworx, Shockwave Medical, Staar Surgical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch Therapeutics, Cytosorbents. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Johnson & Johnson, Takeda Pharmaceutical. Read More
Keeping you up to date on recent developments in cardiology, including: women can reduce stroke risk; Researchers see promise as stroke-damaged rat brains are repaired; Questions raised over blood pressure devices for home monitoring. Read More
