Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Intervene, Tosoh Bioscience.
Bowhead whales (Balaena mysticetus) live year-round in the icy or near-icy waters of the Arctic and sub-Arctic. Although they migrate with the seasonal cycles of ice formation and melting, they never reach the warmer waters visited by other large marine mammals. Their adaptation to low temperatures may have also enabled them to live longer and avoid cancer, a disease closely linked to aging.
Sparrow Acoustics Inc., dba Sparrow Bioacoustics Inc., closed a C$10 million (US$7.15 million) financing round to support continued adoption of its U.S. FDA-cleared Stethophone platform, which allows bioacoustics detection of structural and rhythmic heart anomalies directly through a smartphone. Sparrow is a Software as a Medical Device and the first medically cleared product that uses smartphones to capture and decipher cardiac sounds.
Customed Ltd. has completed its seed funding round, bringing the total capital raised to $6 million. The company has developed a platform which provides orthopedic surgeons with personalized pre-surgical planning and 3D printed surgical tools. The funds will be used to support regulatory approvals in the U.S. and EU, as well as expansion into additional automated orthopedic indications.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Humacyte, Recor Medical, Surmodics, Tactile Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Biostate AI, Bayosthiti AI, Braincheck, Harrison-AI, Medline, Organox, Terumo, Turn Therapeutics.