FDA Clearance for Capsule Monitor with Masimo Capnography
Capsule Technologies has received FDA 510(k) clearance for its Vitals Plus monitoring solution with the Masimo NomoLine ISA CO2 module.
Category: FDA Approvals
FDA Approvals
Latest
FDA Approvals
Latest
FDA Authorized Six Additional COVID-19 Tests This Week
As of Aug 13, 2020, the FDA has now authorized 213 COVID-19 tests under emergency use authorizations.EUAs, including 174 molecular tests, 37 antibody tests, and 2 antigen tests.
FDA Approvals
Popular
Hollister Introduces AnchorFast Guard Oral Endotracheal Tube Fastener
The AnchorFast endotracheal tube fastener features integrated tube protection for critical care teams that want an extra measure of patient protection.
Hillrom’s Remote Monitoring Solution Designed for Extended Care
Hillrom has launched the Hillrom Extended Care Solution, a new, connected remote vital signs monitoring device that combines the Welch Allyn Spot Vital Signs 4400 device with the Connex App and clinician review portal.
Read More
Hillrom launches Volara, Synclara Airway Clearance Devices
Hillrom has launched the Volara System, an oscillation and lung expansion therapy, and the Synclara Cough System, a cough assist device that uses mechanical insufflation-exsufflation.
Read More
FDA Authorizes Enzo Biochem’s SARS-CoV-2 Test
Enzo Biochem Inc has received FDA Emergency Use Authorization (EUA) for its Ampiprobe SARS-Cov-2...
Read More
FDA Authorizes BD Veritor 15-min COVID-19 Antigen Test
The US FDA has authorized the BD Veritor Plus SARS-CoV-2 assay, a rapid, point-of-care, antigen test manufactured by Becton Dickinson.
Read More
FDA Approvals and Rapid Progress In Fight Against Lung Cancer
Since May, the US Food and Drug Administration has approved seven new treatments for lung cancer, hitting a major milestone in the battle against this deadly disease.
Read More
FDA Approves Philips HeartStart AEDs
The FDA has granted premarket approval for the Philips HeartStart FR3 and HeartStart FRx automated external defibrillators, and their supporting accessories, including batteries and pads.
Read More
FDA Approves Circadia Contactless Monitoring System
The Circadia C100 Contactless Monitoring System uses radar to wirelessly detect respiratory rate in adult patients from up to four feet away.
Read More
Self-administered Dupixent Pen Approved for Asthma, CRSwNP
FDA approved a 300 mg single-dose pre-filled pen for Dupixent (dupilumab) to treat atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).
Read More
FDA Approves Zepzelca for Small Cell Lung Cancer
Clinical data showed that in patients with relapsed small cell lung cancer, Zepzelca demonstrated an overall response rate of 35% and a median duration of response of 5.3 months.
Read More
Eight Companies to Manufacture NASA Ventilator, VITAL
Eight US companies were chosen to manufacture the NASA ventilator VITAL, which has received two FDA EUAs to treat COVID-19 patients.
Read More
Fitbit Launches Emergency Ventilator for Use During Covid-19 Pandemic
Fitbit has developed an emergency ventilator, Fitbit Flow, which has obtained Emergency Use Authorization from the FDA for use during the COVID-19 public health emergency.
Read More
FDA Authorizes Philips Acute Care Monitoring Tech
The US FDA has issued emergency use authorization for the Philips IntelliVue MX750/MX850 and its IntelliVue AD75/AD85 for use during the COVID-19 health emergency.
Read More