The U.S. Justice Dept. announced that Avanos Medical (NYSE:AVNS) agreed to pay more than $22 million to resolve a criminal charge related to fraudulent misbranding. Charges levied against the Alpharetta, Ga.-based medical device company relate to alleged fraudulent misbranding of its MicroCool surgical gowns. According to a DOJ news release, criminal information filed on July […]
Lab Instruments & Supplies
Feds to spend $1.6B to expand COVID testing, domestic manufacturing
The Biden administration announced plans today to expand COVID-19 testing across the country, boost domestic manufacturing of tests and testing supplies and increase virus genome sequencing to detect virus variants. The departments of Health and Human Services and Defense will jointly invest $650 million to expand testing for K-8 schools and underserved congregate settings, such […]
DTW Podcast: Zimmer Biomet slims, Corza Medical grows in pursuit of grabbing market share
In this week’s DeviceTalks Weekly Podcast, Rich Newitter, managing director at SVB Leerink, says Zimmer Biomet’s decision to spin out its spinal and dental business will accelerate its already impressive market share grab in its core orthopedics industry. Newitter says CEO Bryan Hanson brings a tried-and-true diversification model used by companies like his former employer, […]
7 takeaways from Biden’s ‘full-scale, wartime’ plan to combat the COVID-19 pandemic
President Joe Biden kept to his word to announce plans to “establish clear federal leadership” to tackle the coronavirus pandemic on his first full day in office. The White House issued a 200-page document on Wednesday, detailing “full-scale, wartime” plans to harness the nation’s manufacturing and distribution capabilities to boost vaccine production, end shortages of […]
FDA adds to pandemic-related shortage list
The FDA today announced new shortages of laboratory testing supplies needed for the COVID-19 pandemic and renewed its shortage listing for several types of personal protective equipment (PPE). Newly categorized as being in short supply are micro-pipettes and what the agency described as general-purpose lab equipment. Read the full list on our sister site, Medical […]
FDA allows dry heat treatment for single-user mask reuse
The FDA has announced that it will allow the use of dry heat to lower the bioburden on masks used by healthcare workers treating COVID-19 patients. While not authorizing equipment made by a particular company, guidance released last week said healthcare providers may use dry heat to reprocess NIOSH-approved filtering facepiece respirators, such as N95s, […]
BD adds informatics option to its COVID testing platforms
Healthcare providers who use the Becton Dickinson (NYSE:BDX) BD Veritor Plus and BD Max COVID-19 testing platforms have a new informatics option. BD announced today that it has launched new reporting capabilities for COVID-19 data, enabling its BD Synapsys informatics to generate scheduled reports. BD Veritor Plus is a portable instrument designed to deliver SARS-CoV-2 antigen […]
Sotera Health files for $1.1 billion IPO
Sotera Health has filed with the SEC to confirm its intent to raise nearly $1.1 billion in an initial public offering. Broadview Heights, Ohio-based Sotera Health said in the filing out yesterday that it expects to sell 46.6 million shares of its common stock at an assumed IPO price of $21.50 per share, totaling $949.3 […]
Supply chain tool IDs COVID-19 supply shortages
The American Society for Microbiology (ASM) has developed an online platform to identify COVID-19 and non-COVID testing supply shortages. In partnership with the Associaton for Supply Chain Management (ASCM), ASM developed the platform to identify and monitor the testing supplies to be made aware of shortages in real-time, according to a news release. The tool […]
BD’s automated flow cytometry system wins FDA clearance
Becton Dickinson (NYSE:BDX) today announced it has received 510(k) clearance from the FDA for its FACSLyric flow cytometer with the integrated BD FACSDuet sample preparation system. The system enables clinical laboratories to fully automate the sample-to-answer process and improve their efficiency by reducing errors and limiting the manual user interactions required to run assays on the […]
Federal watchdog tells HHS, FEMA and DoD: You can do better on COVID-19
The General Accounting Office (GAO) took three major federal departments to task today on their coronavirus responses and gave some pointed advice for the future. In a wide-ranging report, the GAO told the Department of Health and Human Services (HHS), the Federal Emergency Management Agency (FEMA) and the Department of Defense (DoD) how to better manage coronavirus-related […]
