Early Alert for CooperSurgical Neonatal nCPAP Device
CooperSurgical has issued a letter to affected customers recommending certain ventilators be removed from where they are used or sold, according to a USFDA early alert.
Category: Industry & Regulatory News
Industry & Regulatory News
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Industry & Regulatory News
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COPD Foundation to Host Patient-Focused Drug Development Meeting
The COPD Foundation announced an upcoming meeting to ensure patient experiences and priorities are incorporated into the future of therapeutic development.
Industry & Regulatory News
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Intelligenome, Cornell Partner on Portable TB Diagnostic
The collaboration will focus on a point-of-care testing platform designed to detect tuberculosis from respiratory and blood samples.
Association News
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3 Things to Know About Expanded Access Programs
An American Lung Association initiative aims to educate patients and healthcare providers about investigational treatment options for severe and rare lung diseases.
Business News
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Monash, Brigham and Women’s Renew Sleep Research Partnership
The collaboration will focus on sleep and circadian medicine, including research into obstructive sleep apnea and wearable health technology.
FDA Approvals
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FDA Authorizes Syncron-E Software for Patient-Ventilator Asynchrony
Autonomous Healthcare received FDA De Novo marketing authorization for Syncron-E, a software that supports the assessment of patient-ventilator asynchrony by detecting evidence of ineffective efforts.
Recalls & Advisories
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Saline Nasal Spray Recalled Due to Contamination Risk
Beekeeper’s Naturals issued a voluntary nationwide recall for one lot of its saline nasal spray because of potential microbial contamination, according to an alert from the USFDA.