FDA clarifies cybersecurity recommendations for device makers in new guidance
The draft guidance, which replaces a 2018 document, sets recommendations for how medical device companies should approach cybersecurity in premarket submissions.
FDA sees ‘appropriate’ transition period for COVID-19 test EUAs when public health emergency ends
FDA is planning to give holders of EUAs for COVID-19 diagnostics and other devices 180 days notice of its intent to terminate their authorizations, in anticipation of U.S. public health emergency declarations no longer being in effect.
Advocate Aurora investment arm acquires remote monitoring firm
This is the fourth transaction for the newly minted Advocate Aurora Enterprise, which launched last year with the aim of building a portfolio of companies beyond acute medical care.
FDA advisers grapple with how to update COVID-19 vaccines
About half of eligible Americans haven’t received a booster and may be less protected should cases surge. Health officials hope to soon ready an updated shot, but experts on the committee struggled to identify the best approach.
Telehealth use rose for third straight month in January as omicron spread
Among the five telehealth diagnoses in January, COVID-19 tied for second with acute respiratory diseases and infections. Mental health conditions were by far the most common diagnosis, coming in at nearly 60% of all claims.
FDA halts Vir, GSK antibody use in response to COVID subvariant’s spread
The COVID-19 treatment had a brief time in the spotlight as one of the few drugs that’s potent against the omicron variant. A substrain called BA.2 is now dominant in the U.S., however.
‘Where’s the patient?’: Experts question FDA’s final recall guidance
While the guidance encouraged the use of electronic communications in recalls, a change experts have advocated for, some questioned why the agency did not address more problems with the system.
Surprise billing compliance ‘very daunting,’ regulatory experts say
The bill is best known for its signature achievement, but there are lesser known requirements that are difficult to put into practice, compliance experts told Healthcare Dive.
CAR-T treatment moves earlier as FDA widens approval of Gilead’s Yescarta
There are some obstacles to use. Yescarta is expensive, priced by Gilead at $373,000 per patient. Treatment is now widely covered by insurance, but the cost can still present hurdles for patients, depending on their coverage plans.
Biden proposes rule to fix ACA’s ‘family glitch’
The new regulation could help an estimated 200,000 uninsured Americans gain coverage, while 1 million could benefit from less expensive plans.