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FDA Clears Ear-Worn Pulse Oximeter

The wearable provides continuous, real-time measurement of blood oxygen saturation and pulse rate.

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FDA Clears Digital Insomnia Treatment SleepioRx

The digital therapeutic uses cognitive behavioral therapy to treat chronic insomnia in adults, with clinical trials showing up to 76% efficacy.

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FDA Approves Merck’s Pneumococcal Vaccine for Adults

The vaccine covers serotypes responsible for approximately 84% of invasive pneumococcal disease in adults 50 years of age and older.

FDA Clears Masimo’s Stork Baby Monitoring System for OTC Use

by RT Staff | May 6, 2024 | Patient Monitoring | 0

With the clearance, Stork is available for at-home monitoring of oxygen saturation, pulse rate, and skin temperature in babies without a prescription.

FDA Approves Genentech’s Alecensa for Early-Stage ALK-Positive NSCLC

by RT Staff | Apr 19, 2024 | FDA Approvals | 0

Genentech says the approval makes the drug the first ALK inhibitor for patients with ALK-positive, early-stage non-small cell lung cancer who have undergone surgery.

FDA Expands Use of Fasenra for Children Age 6 to 11

by RT Staff | Apr 11, 2024 | Asthma, FDA Approvals | 0

The additional indication is for pediatric patients aged 6-11 with severe eosinophilic asthma.

FDA Clears AlphaVac F1885 System for Treatment of Pulmonary Embolism

by RT Staff | Apr 4, 2024 | Pulmonary Embolism | 0

The clearance broadens the applicability of the AlphaVac F1885 System in the non-surgical removal of thrombi or emboli from the venous vasculature.

FDA Approves New Antibiotic for Community-acquired Bacterial Pneumonia

by RT Staff | Apr 4, 2024 | FDA Approvals | 0

The injection received FDA approval for adults and pediatric patients aged 3 months and older.

Respiratory Sore Throat Diagnostic Cleared by FDA

by RT Staff | Apr 2, 2024 | Diagnostics, FDA Approvals, Testing | 0

The BioFire SpotFire Respiratory/Sore Throat (R/ST) Panel received FDA 510(k) clearance and CLIA) waiver approval, according to bioMérieux.

Biofire Spotfire R/ST Panel Gets 510(k) Clearance, CLIA-waiver Approval

by RT Staff | Mar 28, 2024 | Diagnostics, FDA Approvals | 0

bioMérieux received FDA 510(k) clearance and CLIA waiver approval for the Biofire Spotfire Respiratory/Sore Throat (R/ST) Panel.

FDA Approves Merck’s Injection for Pulmonary Arterial Hypertension

by RT Staff | Mar 27, 2024 | FDA Approvals, Pulmonary Hypertension | 0

The injection on top of background therapy significantly improved exercise capacity and multiple secondary outcome measures compared to background therapy alone.

FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy

by RT Staff | Mar 22, 2024 | FDA Approvals, Other Chronic Diseases, US Pharmaceuticals | 0

Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of Duchenne Muscular Dystrophy.

FDA Clears AIO Breathe Oral Appliance for Sleep Apnea

by RT Staff | Feb 29, 2024 | Breathing Disorders | 0

The mandibular repositioning device acts by increasing the patient’s airway during sleep, improving the ability to exchange air, thereby reducing the tendency to snore and alleviating signs of OSA.

FDA Approves Osimertinib plus Chemotherapy for EGFR-mutated NSCLC

by RT Staff | Feb 20, 2024 | FDA Approvals, Lung Cancer, US Pharmaceuticals | 0

The FDA approved osimertinib (Tagrisso) with platinum-based chemotherapy for certain patients with non-small cell lung cancer (NSCLC).

FDA Approves Xolair as First Drug to Treat Food Allergies

by RT Staff | Feb 20, 2024 | Allergies, FDA Approvals | 0

Previously approved to treat asthma and nasal polyps, Xolair has now received FDA approval as the first treatment for reducing food allergy reactions in both children and adults.

Tag: FDA approval clearance

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