The U.S. FDA and industry have been in scramble mode for some time to address the Environmental Protection Agency’s actions on ethylene oxide, but some manufacturers must also deal with other regulators’ perceptions of what constitutes an acceptable method of sterilization. Read More
The Australian government is investing AU$1.89 billion (US$1.25 billion) in what it is calling a “once-in-a generation transformation” of health and medical research in Australia with $1.4 billion tagged for new research for the Medical Research Future Fund. Read More
Researchers have developed a new blood collection device inspired by the behavior of a leech which attaches itself to a host, penetrates their skin with its teeth and swallows to create negative pressure drawing blood. Read More
Based on its analysis of a large cohort of individuals homozygous for the ε4 variant of apolipoprotein E (APOE4), a multinational team of researchers is arguing that homozygosity for APOE4 should be considered a genetic form of Alzheimer’s disease. However, not everyone agrees that the findings warrant reclassifying APOE from risk factor to causal gene. Currently, APOE4 is classified as the strongest risk factor for developing AD. Another variant, the APOE2 variant, is protective, while APOE3 is neutral. Read More
Mexico’s Federal Commission for Protection Against Sanitary Risk (COFEPRIS) has released a draft proposal that would overhaul the 2008 version of the rule for device labeling, a document that includes several key proposed reforms. Read More
Researchers from the University of Pittsburgh have developed a device designed to collect exhaled respiratory aerosols from mechanically ventilated patients. Their device is designed to be non-invasive, highly efficient and can be readily placed in the exhalation line of ventilators without interfering in the functions of the ventilator. Read More
The recent cyberattack on Change Healthcare, a part of the Unitedhealth Group, crippled reimbursement claims processing for thousands of providers for several weeks and potentially exposed troves of patient data. Congressional committees are investigating the attack, its scope, and Unitedhealth’s response. Please take a few minutes to fill out this short survey to help BioWorld understand how your company is responding to these threats. You can click through to the questions here. Read More
New hires and promotions in the med-tech industry, including: Beaconcure, Blackwell Security, Celerion, Cagent Vascular, Crm Surgical, Otolith Labs, Sapient, Trisalus. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cerevasc, Geneoscopy, Golden Helix. Read More
