Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Baraseen Medical, Bio-Techne, Mediflow, Nexalin, Novomol-Dx, Roivios, Senzime, Siemens Healthineers, Varian Medical Systems.
In what represents just the third PCT filing to have been published in the name of Zurich, Switzerland-based Siva Health AG, protection is sought for a computer-implemented method of classifying an individual suffering from chronic cough.
Device recalls may seem an ordinary fact of life, given that some are declared for reasons as innocuous as a change of labeling, but the five device recalls announced by the U.S. FDA April 24 and 25 include one product withdrawal. The recall for the Nimbus series of infusion pumps and administration sets by Infutronix LLC cited instances in which patients were subjected to out-of-specification analgesia flow rates, and the company has seen fit to remove the existing inventory from the market.
In March, the U.S. FDA reported a major shortage of Rhogam, the anti-D immune globulin most widely used to prevent Rh factor incompatibility in pregnancy. Without treatment, second and subsequent pregnancies can be endangered by antibodies created by the mother. With the shortage, the standard treatment of two shots for all pregnant females with Rh-negative blood can be challenging, but Billiontoone Inc.’s Unity prenatal test can eliminate the need for the immune globulin treatment in 40% of these pregnancies.
Front Line Medical Technologies Inc. recently received CE mark for its Cobra-OS, the smallest REBOA (resuscitative endovascular balloon occlusion of the aorta) device for use in emergency situations on the market. The company believes that Cobra-OS could help save the lives of patients during traumatic bleeding situations as it could buy valuable time until definitive care can be provided.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4Web Medical, Provisio.