FDA Issues Early Alert for Resmed Ventilators
Resmed has recommended corrections to certain Astral 100 and Astral 150 ventilators due to an issue that may result in interrupted therapy.
Category: Industry & Regulatory News
Industry & Regulatory News
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Industry & Regulatory News
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FDA Clears AMDI Fast PCR Respiratory Panel for Point-of-Care Testing
The AMDI Fast PCR System provides point-of-care results for RSV, influenza, and COVID-19 in less than 10 minutes.
Industry & Regulatory News
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FDA Approves Capvaxive Pneumococcal Vaccine for Children 2-17
The USFDA approved an expanded indication for Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) to include children and adolescents aged 2 through 17 years, according to Merck.
Association News
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American Thoracic Society Appoints New President
Michelle Ng Gong succeeds Raed Dweik as president of the American Thoracic Society.
Business News
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Perma Pure and Maxtec Unify as Salaera
Perma Pure and Maxtec have unified under a new parent company, Salaera, to form a global technology platform for breath and gas systems.
FDA Approvals
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FDA Approves Benralizumab for Hypereosinophilic Syndrome
Benralizumab (Fasenra) is now indicated to reduce the risk of flare ups for adult and pediatric patients with hypereosinophilic syndrome.
Recalls & Advisories
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VOCSN V+Pro Ventilators Recalled by React Health
React Health is removing certain VOCSN V+Pro units due to a potential oxygen leak condition prior to or during ventilation.