Avenda Health Inc. secured FDA 510(k) clearance for its Iquest platform, which uses artificial intelligence to map the location of a tumor within the prostate. The visualization created provides better assessment of the extent of the malignancy and improves selection of treatments. Avenda raised $10 million in August to support development of Iquest, which guides the company’s Focalpoint laser ablation system. Read More
Medical device manufacturers that hire outside counsel to conduct investigations of a facility’s quality system can expect an outsider’s view and might have the benefit of more candor on the part of quality staff than would otherwise be available. Read More
Mainstay Medical Holdings plc released data from a one-year, real-world, study of patients implanted with a neurostimulation device to treat chronic lower back pain. Read More
Biocorp Production SA has been awarded 510(k) clearance from the U.S. FDA to market Mallya as a medical device that connects insulin pens. The news, out on Dec. 8, led Biocorp’s stock price to jump 32.69% to $21.52. Read More
Vaxxas Pty. Ltd. raised AU$34 million (US$23 million) to advance its needle-free COVID-19 vaccine program, which began in early November, and readouts from the study are expected in late February or early March, Vaxxas CEO David Hoey told BioWorld. The COVID-19 vaccine patch is based on the company’s high-density microarray patch technology that delivers Hexapro, a second-generation version of the spike protein used in all major U.S.-approved COVID-19 vaccines. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Compugroup Medical, Cord, Corvia, Diagnostic Systems, Evolve Manufacturing, Heartbeam, Helix, IBA, Ion Beam, Medicus Laboratory, Northern Light Health, Quest Diagnostics, Wellspan Health. Read More
