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Federal Court Finalizes Consent Decree Against Philips Respironics

The decree mandates a recall remediation plan and production restrictions to address safety concerns following the widespread 2021 recall of CPAP and BiPAP machines.

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FDA Panel Proposes Solutions to Eliminate Racial Bias in Pulse Oximeters

An FDA panel proposed revisions to premarket guidelines for evaluating pulse oximeter performance in order to eliminate racial bias and improve accuracy across various skin pigments.

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FDA Clears AI-Powered Idiopathic Pulmonary Fibrosis Diagnostic

According to Imvaria, the device’s manufacturer, the clearance signifies the first FDA authorization of a diagnostic tool of any type in lung fibrosis.

Class I Recall for Olympus Bronchofiberscopes and Bronchovideoscopes

by RT Staff | Dec 19, 2023 | Recalls & Advisories | 0

Olympus Corp is recalling certain bronchofiberscopes and bronchovideoscopes because they may lead to burns or catch fire.

$18 Million Worth of Illegal E-Cigarettes Seized in Federal Operation

by RT Staff | Dec 14, 2023 | Vaping & E-Cigarettes | 0

The FDA and CBP seized approximately 1.4 million units of unauthorized e-cigarette products, including popular youth-targeted brands such as Elf Bar.

Getinge Recalls ECMO Device Due to Critical Malfunction Risks

by RT Staff | Dec 8, 2023 | Cardiopulmonary & Thoracic, Recalls & Advisories | 0

Getinge is recalling the Cardiohelp Emergency Drive due to possible blocking or impairment of the emergency drive’s cranking ability.

FDA Clears Vivos’ Oral Appliances for Severe Sleep Apnea

by RT Staff | Nov 29, 2023 | Breathing Disorders, FDA Approvals | 0

Vivos Therapeutics’ CARE oral appliances received FDA clearance for treating moderate to severe sleep apnea in adults.

FDA: ‘Carefully Monitor’ Philips CPAP Device for Overheating

by RT Staff | Nov 28, 2023 | Recalls & Advisories, Therapy Devices | 0

The FDA received over 270 reports related to thermal issues such as fire, smoke, burns, and other signs of overheating while patients are using Philips DreamStation 2 CPAP machines.

FDA Clears Critical Care Suite With AI-Powered Pneumothorax Detection

by RT Staff | Nov 28, 2023 | Diagnostics, FDA Approvals | 0

The algorithm provides immediate notification of the presence or absence of pneumothorax, as well as an overlay display both on-device and in PACS to assist with pneumothorax localization.

FDA Clears CT-based Lung Function Scanning Software

by RT Staff | Nov 27, 2023 | Diagnostics, FDA Approvals | 0

The software scans and analyzes CT images, providing data on regional lung function using existing CT scanning equipment.

Investigational mRNA Cystic Fibrosis Treatment Granted Orphan Drug Designation

by RT Staff | Nov 27, 2023 | Cystic fibrosis | 0

The drug candidate utilizes a lipid-mediated aerosolized platform to deliver CFTR messenger RNA to the lungs.

FDA to Tackle Racial and Ethnic Disparities in Pulse Oximetry

by RT Staff | Nov 20, 2023 | Patient Monitoring | 0

The FDA’s Center for Devices and Radiological Health is set to hold a virtual public meeting on Feb 2 to discuss new approaches for evaluating pulse oximeter performance, focusing on accuracy across various racial and ethnic groups.