Regulations/Legal
FDA: Reports of squamous cell carcinomas, lymphomas in breast implant scar tissue
Editor's Note The Food and Drug Administration (FDA) on September 8 issued a Safety Communication informing the public about reports of cancers, including squamous cell carcinomas and various lymphomas in the scar tissue that forms around breast implants. The various lymphomas are not the same as the lymphomas reported in…
AHA releases part 3, final workforce guide series
Editor's Note The American Hospital Association (AHA) on September 7 released part three of a three-part series of its workforce guide focused on strategies, resources, and case studies from hospitals and other health systems. The AHA Board of Trustees’ Task Force on Workforce provided guidance for the series with input…
Nasal COVID-19 vaccine approved in China and India
Editor's Note China and India approved COVID-10 vaccines given through the nose or mouth, which scientists have claimed to be a “game changer” for the pandemic, BBC News September 5 reports. The novel vaccine targets the mucous membranes and starts an immune response where the coronavirus enters the body. The…
FDA alerts patients, providers of Philips Respironics masks recall
Editor's Note The Food and Drug Administration (FDA) issued a safety communication alert on September 6 informing patients, caregivers, and healthcare providers that Philips Respironics (Philips) has recalled certain masks used with bilevel positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due…
Racial disparity worsens in monkeypox infections as cases decline
Editor's Note White House officials said on Wednesday, September 7, that despite worsening racial disparities in reported monkeypox cases, they are optimistic about the decline in cases and the increase in vaccinations. Dr Demetre Daskalakis, deputy coordinator of the White House national monkeypox response, said vaccination will be offered in…
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…
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