FDA Authorizes Importation of Tentatively-Approved Narcolepsy Drug
The authorization allows the company to shorten the time to product availability following an anticipated final approval decision from the FDA.
The authorization allows the company to shorten the time to product availability following an anticipated final approval decision from the FDA.
The FDA approved Signifier’s request to remove certain contraindications for its daytime sleep apnea therapy device, a “milestone” approval Signifier says will allow greater patient reach.
Philips Respironics recalls more devices but the BiPAP recall is unrelated to the PE-PUR foam issue.
Genio 2.1’s upgrades are entirely related to the external components of the Genio system, as the implantable stimulator remains unchanged.
The Gazette: Peggy Waters reported being diagnosed with sleep apnea in 2014 while working at the university.
Lifesaving equipment is being denied payment because of rigid criteria in local coverage determinations and existing coverage provided by CMS is not reflective of rapidly evolving technology in the field.
Cincinnati.com: The US Attorney's Office alleges that Mercy Health made medically unnecessary claims for machines used to treat sleep apnea.
The commission investigation has found that for several years, this “pay-for-delay” agreement eliminated Teva as a competitor and allowed Cephalon to continue charging high prices even if the main modafinil patent had long expired.
Washington Post: A Washington Metrorail Safety Commission report finds that Metro needs to ensure that operators take enough days off to stay alert, while getting tested and treated for medical issues such as sleep apnea.