Biobeat Technologies Ltd. expanded its U.S. FDA-cleared remote patient monitoring offerings with a double nod from the agency for its sensors to monitor stroke volume and cardiac output. The two new indications join its capabilities for measuring the five vital signs assessed in any medical visit—blood pressure, blood oxygen saturation, pulse rate, respiratory rate and body temperature—all of which can be done using photoplethysmography (PPG) on sensors embedded on either a short-term chest patch or a more durable wrist monitor. Read More
More than one U.S. federal government agency is tasked with keeping track of fraud and abuse of federal health programs, but a new report by the Government Accountability Office (GAO) suggests there is more work to be done. The GAO report said that one of the key issues with fraud and abuse writ broadly is that the terms and definitions are used inconsistently, and that a fix for this and other problems might capture more fraud, which may in turn indirectly put more medical device makers at risk for such allegations. Read More
Brazilian health care regulator Anvisa unveiled new medical device rules that promise to simplify over two decades of accumulated directives, putting into force changes announced by the health care surveillance agency in 2022. Read More
Fraud perpetrated on U.S. federal health care programs is the stuff of nightmares among U.S. enforcement agencies, and yet another pair of fraudsters have been rounded up by the Department of Justice (DOJ). Read More
Sysnav Healthcare SA and Roche Holding AG entered a new collaboration to develop digital endpoints for use in clinical trials of therapies for a range of neuromuscular disorders. The alliance combines Sysnav’s expertise in wearable technologies and movement evaluation with Roche’s clinical experience. It builds on an existing collaboration that led to the qualification of the world’s first digital endpoint, for evaluating therapies in development for Duchenne muscular dystrophy (DMD). They now aim to put that experience to work in widening its application to other disorders in which movement is a key parameter. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bayer, Blackford Analysis, Brainomix, Fujifilm, Inspirata, Koru, Medalliance, Modular Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Geneseeq Technology, Tidepool. Read More
