Nevro Corp. has submitted a premarket approval supplement to the U.S. FDA seeking a green light for its Senza system to treat chronic pain associated with painful diabetic neuropathy (PDN). This submission is expected to allow the company to gain approval and kick off U.S. launch activities for this indication in the second half of next year. Nevro would be tapping into a big market, as diabetes affects roughly 1 in 10 adults in the U.S. and can damage peripheral nerves, resulting in severe pain and numbness in the extremities. Read More
LONDON – A huge row has broken out in the U.K. about the accuracy and utility of COVID-19 lateral flow tests (LFT) in screening asymptomatic people, as a pilot field study indicated sensitivity is less than 40%, and a nationwide roll out already is in train. At present 116 areas of the country are due to implement community testing from next month, health care workers are due to be handed personal LFT supplies to test themselves twice a week, and the government is about to mandate use of the tests in schools after Christmas. Read More
Coagulo Medical Technologies Inc. raised $6.5 million in financing to accelerate delivery of its precision-medicine coagulation diagnostics platform. 20/20 Healthcare Partners led the investment with participation from Sands Capital, Good Growth Capital, IAG Capital Partners, and private investors. The company also received funding through a Small Business Innovation Research (SBIR) grant from the National Science Foundation to develop a COVID-19-related coagulation test. Read More
U.S. federal government enforcement of the Foreign Corrupt Practices Act (FCPA) might not draw the attention that other matters draw, but the Securities and Exchange Commission (SEC) has made extensive use of the FCPA in 2020. SEC actions related to the FCPA may have accounted for only about 2% of the agency’s actions over the past year, but nonetheless accounted for nearly 80% of the penalties collected by the agency, and health care was second only to the oil and gas industries as the targets of FCPA action by the agency. Read More
Scientists at Duke University School of Medicine in Durham, N.C., have developed a small-molecule inhibitor of the cellular stress-protective transcription factor, heat-shock factor 1, which showed developmental promise against treatment-resistant prostate cancer and other cancers. The small molecule, Direct Targeted HSF1 InhiBitor (DTHIB), may also be a useful research tool for investigating the regulation and role of HSF1 in basic stress biology and in cancer. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Collagen Matrix, Degradable Solutions, Dilon Technologies, Digirad, Dw Healthcare Partners, Eyenovia, Orthopediatrics, Smart Breast, Star Equity Holdings, Teleflex, Z-Medica. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Distalmotion, Inex Innovate, Quanterix. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: U.S. FDA provides updates on power morcellation; FDA seeks nominations for advisory committee; CDSCO suspends import notification requirements. Read More
Keeping you up to date on recent developments in oncology, including: Microscopic robots inch closer to clinical practicability; One thing often leads to another for cancer patients; PARP inhibitors under more scrutiny; New liposome may suppress false positives in FDG-PET. Read More
