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

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.

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FDA Approves Osimertinib plus Chemotherapy for EGFR-mutated NSCLC

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

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FDA Approves First CRISPR-based Therapy for Sickle Cell Disease

The FDA approved the first cell-based gene therapies for the treatment of sickle cell disease in patients 12 years and older. One therapy, Casgevy, is the first FDA-approved treatment to utilize the genome editing technology CRISPR/Cas9

FDA Clears Empatica Monitoring Platform for Respiratory Rate and Pulse

by RT Staff | Nov 7, 2023 | FDA Approvals, Patient Monitoring | 0

The FDA granted Empatica 510(k) clearance for two new digital biomarkers for its Empatica Health Monitoring Platform: pulse and respiratory rate.

FDA OKs Noninvasive Neurostimulator for Insomnia

by RT Staff | Nov 6, 2023 | FDA Approvals, Insomnias | 0

The device is designed to improve insomnia by delivering a small electrical pulse to the head for 30 minutes before bed.

FDA Clears Bedside Device for Contactless Remote Patient Monitoring

by RT Staff | Oct 10, 2023 | Industry & Regulatory News, Patient Monitoring | 0

The FDA has cleared a contactless bedside device that uses macro- and micro-motion to remotely monitor vital signs in patients with chronic conditions.

FDA Approves Moderna’s Updated COVID-19 Vaccine

by RT Staff | Sep 11, 2023 | FDA Approvals, US Pharmaceuticals | 0

The FDA approved Moderna’s updated COVID-19 vaccine (Spikevax) for ages 12 years and above, and issued emergency use authorization for children age 6 months through 11 years old.

FDA Clears Ring for Pulse Oximetry

by RT Staff | Sep 11, 2023 | Diagnostics, FDA Approvals, Patient Monitoring | 0

The US Food and Drug Administration has granted BodiMetrics 510k clearance for its circul pro ring as a pulse oximeter.

FDA Clears Alveoair Digital Spirometer

by RT Staff | Sep 7, 2023 | Business News, Diagnostics, FDA Approvals | 0

The US FDA has granted 510(k) clearance to the alveoair digital spirometer, according to a press release by the manufacturer, alveofit.

FDA Clears Essenz In-Line Blood Monitor

by RT Staff | Aug 31, 2023 | Cardiopulmonary & Thoracic, Critical Care, FDA Approvals, Patient Monitoring | 0

LivaNova has received FDA 510(k) clearance for its Essenz In-Line Blood Monitor, which provides continuous measurement of blood parameters to perfusionists throughout cardiopulmonary bypass procedures.

FDA Clears Wearable Tech for Continuous Patient Monitoring

by RT Staff | Aug 16, 2023 | FDA Approvals, ICU & Ventilation, Patient Monitoring | 0

The wearable, wireless monitoring solution provides a real-time view of patients while monitoring dual vector respiration rate, SpO2, and pulse rate continuously.

FDA Clears GE Healthcare’s Portrait Mobile Wireless Monitoring Solution

by RT Staff | Aug 14, 2023 | FDA Approvals, Patient Monitoring | 0

GE HealthCare’s Portrait Mobile platform enables real-time continuous monitoring with a personalized view of the patient’s vitals while keeping patients mobile during critical recovery periods, especially after surgery or discharge from the intensive care unit.

Tag: FDA approval clearance

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