Most-read FDA actions from 2023 in pulmonology
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Healio Pulmonology has compiled the top news from the FDA posted in 2023.
Top FDA pulmonology stories from this year include the clearance of a proprietary daytime-nighttime appliance (Vivos Therapeutics) to treat patients with mild to moderate obstructive sleep apnea and the approval of a fixed-dose combination rescue inhaler of albuterol/budesonide (Airsupra; Avillion, AstraZeneca) for adults with asthma.
Notably, three of the top 10 FDA stories focused on issues with Philips Respironics products.
Read these and more of the most-read FDA pulmonology stories of 2023 below.
FDA grants 510(k) clearance to obstructive sleep apnea treatment device
The FDA has granted 510(k) clearance to a daytime-nighttime appliance, or DNA, to treat patients with mild to moderate OSA, according to a manufacturer-issued press release. Read more.
FDA approves Airsupra, fixed-dose combination rescue asthma inhaler for adults
The FDA approved a pressurized metered-dose inhaler with a fixed-dose combination of albuterol and budesonide for use as rescue medication among patients with asthma aged 18 years and older, according to a manufacturer-issued press release. Read more.
FDA grants 510(k) clearance to at-home sleep apnea test sensor
The FDA granted 510(k) clearance to an at-home test device (Sunrise) that can diagnose OSA and other sleep-related breathing disorders. Read more.
FDA warns of Philips CPAP machines overheating, causing patient injuries
The FDA issued a safety communication regarding reports of fire, smoke, burns and other signs of overheating in DreamStation 2 CPAP machines by Philips Respironics. Read more.
FDA grants orphan drug designation to AI-created drug for idiopathic pulmonary fibrosis
The FDA granted orphan drug designation to INS018_055 (Insilico Medicine), an anti-fibrotic small molecule inhibitor, for treating patients with idiopathic pulmonary fibrosis, according to the drug’s manufacturer. Read more.
FDA grants 510(k) clearance to robotic navigated bronchoscope system
The FDA granted 510(k) clearance to the Galaxy System (Noah Medical), a robotic navigated bronchoscopy system, which will aid in diagnosing patients with lung cancer, according to a manufacturer-issued press release. Read more.
FDA sends warning to AstraZeneca on misleading COPD therapy promotional communications
Due to misleading claims in a sales aid for Breztri Aerosphere, a triple inhaled therapy for COPD, the FDA has issued a warning letter to its manufacturer, AstraZeneca. Read more.
FDA ‘remains unsatisfied’ in Philips Respironics ventilator, sleep apnea device recall
The FDA asked for more testing regarding the recall of certain Philips Respironics ventilators, bilevel positive airway pressure machines and continuous positive airway pressure machines. Read more.
FDA designates Philips Respironics DreamStation recall as class I
The FDA designated Philips Respironics’ recall of DreamStation devices as a class I recall, the most serious kind. Read more.
FDA approves Trikafta for children aged 2 to 5 years with cystic fibrosis
The FDA has expanded use of elexacaftor/tezacaftor/ivacaftor (Trikafta, Vertex Pharmaceuticals) for children aged 2 to 5 years with cystic fibrosis with certain mutations, according to a press release. Read more.