Medtronic plc is highlighting the publication of primary endpoint results from the In.Pact AV Access trial in the New England Journal of Medicine. The study found that the company’s paclitaxel-coated balloon limits the number of reinterventions needed to maintain blood flow in patients with end-stage renal disease who have arteriovenous fistulae. Read More
The U.S. FDA has granted emergency use authorization (EUA) to Lumiradx UK Ltd. for its point-of-care SARS-CoV-2 antigen test, which aims to speed the diagnosis of people suspected of having the virus that causes COVID-19. The test detects antigen nucleocapsid protein from a nasal swab taken from symptomatic patients and delivers results in less than 12 minutes. Read More
PERTH, Australia – An independent review of recent reforms to Australia’s Therapeutic Goods Administration (TGA) advertising framework confirmed that the changes to the new advertising code resulted in improvement, with the new code being clearer and easier to understand. The advertising reforms are part of larger regulatory reforms implemented to increase the pathways for marketing approval for drugs and devices while reducing regulatory red tape and redundancies. Read More
Avoiding the political overtones that seem to be more viral than COVID-19 these days, Anand Shah, deputy commissioner for medical and scientific affairs at the FDA, stressed that even though the agency is making decisions in real time in response to the urgency of the pandemic in the U.S., its decisions are being driven by scientific integrity, regulatory independence and the FDA’s historic commitment to ensuring the safety and efficacy of the products it regulates. Read More
Deep Lens Inc.’s artificial intelligence trial screening and enrollment platform, Viper, will be integrated with Franciscan Health Cancer Center's electronic health record to enable matching of cancer patients with suitable clinical trials starting at diagnosis over the next month. By working together, the two Midwest-based organizations hope to increase the number of patients benefiting from clinical trials and overcome some of the challenges to participation posed by the pandemic. Read More
Columbia University professor and robotics engineer Hod Lipson knows the importance of artificial intelligence (AI) on a global level. “It permeates everything we do, from the stock market, from predicting the weather to what product you’re going to buy,” he said Wednesday during the second day of the virtual Ai4 2020 conference. “It’s even grading essays. You name it.” Read More
Med-tech firms raising money in public or private financings, including: Avantor, Biofidelity, Garwood Medical Devices, Gi Windows Medical, Ontrak, Podimetrics, Science 37, Trellus Health. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Curetis, Lumiradx, Opgen, Pelvital, Zymo Research. Read More
Keeping you up to date on recent developments in diagnostics, including: Antigen test detects spike proteins of SARS-CoV-2; Blood volume assessment study to use Daxor device; Gaining insights into loss of function. Read More
