The COVID-19 pandemic shone a bright light on the need for and utility of telehealth, which in turn prompted the U.S. Centers for Medicare & Medicaid Services (CMS) to temporarily expand telehealth coverage. Some of those coverage policies are set to expire when the public health emergency ends, and a group of stakeholders, including the American College of Cardiology, are urging Congress to pass legislation that would make some of these benefits permanent, a potential boon for many telehealth entities.
Russia’s Ministry of Health is looking to extend its role on the global stage. Over the next few months, the ministry, along with other regulatory agencies in Russia, said it plans to start the accreditation process of coming into compliance with World Health Organization (WHO) standards.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alivecor, Vyspine.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Human Imaging, Aranz Medical, BD, Bittium, Bittium Biosignals, Boston Scientific, Cytognos, Jolly Good, Maeda Kosen, MDK Medical, Medalliance, Medtronic, Otsuka, Preventice, Vitro.
Since COVID-19 hit the U.S. in 2020, the pandemic has taken more than 800,000 American lives. In that same time, cancer has claimed 1.2 million lives, President Joe Biden said Feb. 2 as he “reignited” the cancer moonshot he first launched in 2016 when he was serving as vice president.
LONDON – The first human challenge study of SARS-CoV-2 infection has reported initial results, showing it is safe to infect healthy volunteers with the virus in controlled conditions, and paving the way for the model to be used to accelerate clinical trials of COVID-19 vaccines, antivirals and diagnostics.
Glooko Inc. acquired Xbird GmbH to further build out its diabetes management platform by adding Xbird’s just-in-time artificial intelligence (JITAI) system to provide adaptive interventions that can enable better informed decision making in the moment. The company declined to provide details of the transaction.
The availability of rapid antigen tests for the COVID-19 pandemic has been far short of ideal in recent weeks despite a recent order by the Biden administration for half a billion tests. The question of whether additional federal dollars are forthcoming for additional tests is up in the air, however, due to congressional concerns that there is roughly $800 million in unspent federal dollars, a signal that any additional monies might not be made available any time in the near term.