On Tuesday, July 7, Judge Stacey Jernigan of the U.S. Bankruptcy Court in Dallas ruled that Endologix Inc. could take an initial draw of $10 million from a Chapter 11 loan from its largest lender, Deerfield Partners. A day earlier, Endologix filed a voluntary Chapter 11 case and a consensual plan of reorganization supported by Deerfield. Read More
RapidAI, which focuses on imaging for stroke, has received the U.S. FDA’s nod for Rapid ASPECTS. According to the company, it is the first neuroimaging analysis device to gain clearance in the computer-assisted diagnostic software category. Read More
Machine learning-based diagnostics startup Dascena Inc. has won the U.S. FDA’s breakthrough device designation for its Previse algorithm, which is designed to predict acute kidney injury (AKI) before clinical symptoms. In early validation tests, Previse detected AKI more than a day before patients exhibited kidney damage or impaired function. Read More
The U.S. FDA held a July 7 webinar to go over a recent guidance on decontamination and bioburden reduction of N95 masks for the COVID-19 pandemic, and one of the take-away messages is that the agency is still quite concerned about the impact of residues left over from those processes, given that some of these residues can be inhaled by the wearer and trigger health problems of their own. Read More
After the recent conclusion of the American Diabetes Association (ADA) Scientific Sessions, virtual diabetes management company Onduo LLC held an event with the ADA and diabetes researchers to discuss how technology can help to bridge that gap to empower more diabetes patients. Read More
New hires and promotions in the med-tech industry, including: Bioaffinity Technologies, Bwx Technologies, Coopercompanies, Lyra Therapeutics, Synaptive Medical, Ulab Systems, Vida Diagnostics, Visioncare. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Asuragen, Dascena, Getinge, Ivwatch, Medtronic, Novartis, RapidAI, Soterix Medical, Viveve. Read More
Keeping you up to date on recent developments in oncology, including: Researchers float ChIA PET as answer to prostate cancer puzzle; Dana-Farber offers liquid biopsy for renal cell carcinoma; Inhaled indocyanine green may enable lung tumor margin depiction. Read More