Regulations/Legal
COVID-19 vaccines to become annual shot, say White House officials
Editor's Note On Tuesday, White House officials said COVID-19 vaccinations will likely become an annual affair, similar to flu shots, NBC News September 6 reports. "In the absence of a dramatically different variants, we likely are moving towards a path with a vaccination cadence similar to that of the annual…
CVS, Amazon make billion-dollar healthcare acquisition bids
Editor's Note CVS Health announced on Monday, September 5, that it entered into a definitive agreement with Signify Health, under which CVS will acquire Signify Health for approximately $8 billion (at $30.50 per share). The news comes on the heels of Amazon’s announcement on July 21 that it plans to…
New HHS fund, center to address social media and mental health
Editor's Note In an effort to address the National Mental Health Crisis, the US Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), granted the American Academy of Pediatrics $2 million in funding to establish a National Center of Excellence on Social…
FDA: Class I recall of Integra’s CereLink ICP Monitor
Editor's Note The Food and Drug Administration (FDA) on August 31 identified the recall by Integra of its CereLink ICP Monitor as Class I, the most serious. The recall was initiated because the device may display incorrect values for a patient’s intracranial pressure (ICP) and display out-of-range pressure readings. If…
FDA authorizes updated COVID-19 booster vaccines
Editor's Note The Food and Drug Administration (FDA) authorized updated versions of the Moderna and Pfizer-BioNTech vaccines with the goal of protecting against the recent Omicron variant, NPR August 31 reports. The updated booster, called a bivalent vaccine, offers protection from both the original strain of COVID-19 and the most…
FDA: Class I recall of Hamilton-C6 Intensive Care Ventilator
Editor's Note The Food and Drug Administration (FDA) on August 29 identified the recall by Hamilton Medical AG of its Hamilton-C6 Intensive Care Ventilator as Class I, the most serious. The recall was initiated because of potential water ingress between the indicator board and the ventilator’s main board that may…
New Joint Commission Speak Up program on telehealth
Editor's Note The Joint Commission on August 31 announced a new patient safety campaign to help patients understand telehealth visits, titled: “Speak Up At Your Telehealth Visit.” Educational resources for the Speak Up program include: an infographic poster/flyer an animated video a distribution guide on how to provide the materials…
FDA: Class I recall of Intera 3000 Hepatic Artery Infusion Pump
Editor's Note The Food and Drug Administration on August 29 identified the recall by Intera Oncology of its Intera 3000 Hepatic Artery Infusion Pump as Class I, the most serious. The company is recalling the pumps after receiving reports from clinicians that the pumps were delivering medication faster than expected.…
Moderna sues Pfizer and BioNTech for COVID-19 vaccine patent infringement
Editor's Note On Friday, August 26, the vaccine manufacturer Moderna sued Pfizer and the German drugmaker BioNTech, accusing its competitors of copying technology that Moderna had developed prior to the pandemic, The New York Times August 26 reports. The patent infringement claims could result in a protracted and expensive legal battle…
FDA: Class I recall of Medtronic’s HeartWare HVAD system batteries
Editor's Note The Food and Drug Administration on August 25 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) system batteries as Class I, the most serious. Medtronic is recalling the batteries because they may experience electrical faults that cause them to unexpectedly fail. A similar recall…
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