FDA Approves Comirnaty COVID Vaccine for 12-15 Year Olds
The FDA approved the Pfizer/BioNTech SARS-CoV-2 vaccine (Comirnaty) for active immunization to prevent COVID-19 in individuals 12 through 15 years of age.
Tag: FDA approval clearance
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FDA Clears Wesper Wireless Patch Home Sleep Test
The Wesper platform assists trained personnel in the diagnosis of sleep apnea with data from a wireless patch component the user can apply to their body in the comfort of their own bed.
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FDA Clears Siemens Healthineers’ First-of-its-kind CT Scanning Device
The US FDA has cleared the Siemens Naeotom Alpha, the world’s first photon-counting computed tomography (CT) scanner.
Xolair Prefilled Syringe Approved for self-administration
The US FDA has approved Genetech’s Xolair (omalizumab) prefilled syringe for self-injection for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria, and nasal polyps.
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FDA Approves First Device to Treat Congenital Heart Disease
The US FDA has approved Medtronic’s Harmony Transcatheter Pulmonary Valve (TPV) System, the first in the world nonsurgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract.
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FDA Clears Belluscura’s Portable Oxygen Concentrator, X-plo2r
The US FDA has issued 510(k) clearance and marketing authorization to the X-plo2r portable oxygen concentrator from Belluscura PLC and Separation Design Group.
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FDA Clears Breas Vivo 45 Ventilator
Breas Medical has received FDA clearance for the Vivo 45 LS, one of the smallest, full-featured life support ventilators on the market providing both invasive and noninvasive continuous or intermittent ventilatory support.
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FDA Approves Medication to Prevent Chemo Damage in Lung Cancer
The FDA approved the new medication Cosela for injection to decrease the damage to the immune system and bone marrow from chemotherapy administered for lung cancer.
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Nyxoah Partners with Vanderbilt to Develop More Neurostimulation Tech for OSA
Nyxoah SA is working on getting FDA approval and has signed an exclusive license agreement with Vanderbilt University.
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FDA Authorizes eXciteOSA Daytime Device to Treat Sleep Apnea
The eXciteOSA is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce snoring and mild sleep apnea for patients who are 18 years or older.
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FDA Clears Luna G3 Auto-BPAP
3B Medical Inc has received FDA 510(k) clearance on its third generation bilevel device, the Luna G3 Auto-BPAP, the company announced.
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FDA Approves Tagrisso for NSC Lung Cancer
The US FDA just approved AstraZeneca’s Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation.
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FDA Approves Xolair for Nasal Polyps
Xolair is now FDA-approved across three diseases, including persistent allergic asthma, chronic idiopathic urticaria, and now nasal polyps.
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FDA Expands Xofluza Approval Approval for Post-exposure Prevention
The FDA expanded the approved indication for Genetech’s Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza for patients 12 years of age and older after contact with an individual who has the flu.
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FDA Approves ANDA for Intubation Anesthetic
The US FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, used to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
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