Desaturation

American Journal of Respiratory and Critical Care Medicine Publishes Full, Positive Results of Apnimed’s MARIPOSA Study on AD109, an Investigational Oral Drug for Obstructive Sleep Apnea

Retrieved on: 
Tuesday, October 10, 2023
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AD109 has the potential to be the first-in-class oral treatment for people with mild, moderate and severe OSA.

Key Points: 
  • AD109 has the potential to be the first-in-class oral treatment for people with mild, moderate and severe OSA.
  • The study met its primary endpoint, reduction in Apnea-Hypopnea Index (AHI4, 4% desaturation definition for hypopneas).
  • There were no serious adverse events (SAEs) and no new or unexpected adverse events in the MARIPOSA trial.
  • There were no serious adverse events (SAEs) and no new or unexpected adverse events in the MARIPOSA trial.

Masimo ORi™ Granted De Novo as the First and Only FDA-Cleared Noninvasive and Continuous Parameter to Provide Insight into Hyperoxia Under Supplemental Oxygen

Retrieved on: 
Friday, October 13, 2023
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Masimo (NASDAQ: MASI) today announced that ORi™, a noninvasive, continuous parameter designed to provide additional insight into a patient’s oxygen status in the moderate hyperoxic range under supplemental oxygen, has been granted a De Novo by the FDA.

Key Points: 
  • Masimo (NASDAQ: MASI) today announced that ORi™, a noninvasive, continuous parameter designed to provide additional insight into a patient’s oxygen status in the moderate hyperoxic range under supplemental oxygen, has been granted a De Novo by the FDA.
  • Enabled by the multi-wavelength Masimo rainbow® Pulse CO-Oximetry platform, ORi is designed for use in conjunction with oxygen saturation (SpO2) to provide increased resolution of changes in oxygenation under supplemental oxygen.
  • View the full release here: https://www.businesswire.com/news/home/20231013679815/en/
    Without ORi, there is no noninvasive way to monitor oxygenation under supplemental oxygen to manage hyperoxia, or higher than normal oxygenation of arterial blood.
  • By convention, SpO2 is limited to an upper limit of 100%, but oxygenation can rise into hyperoxia when supplemental oxygen is administered.

Teleflex Incorporated Announces Global Recall of Rüsch Endotracheal Tubes

Retrieved on: 
Wednesday, June 21, 2023
Online, Teleflex, Completeness, Desaturation, Ventilation, Complaint, Death, ET, Tubing (recreation), Patient, Letter, Blow molding, Dietary supplement, Mineral oil, Medical device

All batches of Rüsch Endotracheal Tubes as listed in table above, manufactured between JAN2018 to 24APR2023 are subject to this recall.

Key Points: 
  • All batches of Rüsch Endotracheal Tubes as listed in table above, manufactured between JAN2018 to 24APR2023 are subject to this recall.
  • Reference Appendix 2 of the recall letter for a full list of affected lots / batches.
  • As of 15-June-2023, Teleflex received 189 complaints reporting connector issues for products in scope of this field correction.
  • Should disconnection occur, reconnect the two components promptly and securely in the manner described in the product instructions for use.

Apnimed Presented Positive Phase 2b Results on AD109, an Investigational Oral Drug for Obstructive Sleep Apnea, for the First Time at ATS 2023

Retrieved on: 
Sunday, May 21, 2023
Breaking news, Apnea–hypopnea index, ATS, DC, Confusional arousals, Hypopnea, OSA, Desaturation, International Conference on Population and Development, Obstructive sleep apnea, Conference, News, Safety, Pharmaceutical industry

CAMBRIDGE, Mass., May 21, 2023 (GLOBE NEWSWIRE) -- Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, presented positive results from the MARIPOSA Phase 2b trial, an efficacy, safety and dose-finding study of AD109 over a one-month duration, for the first time in the Breaking News in OSA Mini Symposium today at the ATS 2023 International Conference in Washington, DC.

Key Points: 
  • Dosing with AD109 led to clinically important reductions in AHI in most patients with mild, moderate and severe OSA.
  • MARIPOSA also incorporated other standard clinical endpoints designed to characterize improvement of oxygenation, sleep, and daytime function of patients with OSA.
  • Apnimed plans to advance AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) into Phase 3 following productive discussions with FDA that occurred in February 2023.
  • Apnimed continues to develop and optimize the dosing of this drug for the OSA population.

Draeger issues recall notification to address potential health risks related to possible separation of breathing hose components in certain breathing circuits

Retrieved on: 
Tuesday, April 18, 2023
Return merchandise authorization, Dräger, Obstruction, Person, Desaturation, Ventilation, Single use medical device reprocessing, EUR, Oxygen saturation (medicine), Hypoxia, FDA, Food, NIPPV, Beauty salon, Hydraulic machinery, Pharmaceutical industry, Medical device

For Draeger Neo and Draeger Pediatric disposable breathing systems:

Key Points: 
  • For Draeger Neo and Draeger Pediatric disposable breathing systems:
    A detachment of system components may cause hypoxia due to a loss of airway pressure caused by a leak.
  • Do not depend on any device output (e.g., oxygen desaturation) to make decisions regarding whether to stop using the system.
  • You will also be provided with a Return Material Authorization and pre-paid shipping documents to return the unused product to Draeger.
  • The Draeger Group is currently present in over 190 countries and has more than 16,000 employees worldwide.

Teleflex Announces Worldwide Recall of Gibeck® Iso-Gard® Filter

Retrieved on: 
Thursday, November 3, 2022
Online, Fax, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Letter, Probability, FDA, Prostatic urethral lift, Anesthesia, Urology, Weck, Radiology, Annual report, ET, U.S. Securities and Exchange Commission, Injury, LMA, Desaturation, Quarantine, Health, Filter, Security (finance), Emergency medicine, Patient, Solution, Medical device, Teleflex, QuikClot

Teleflex initiated this voluntary recall on August 29, 2022 due to reports received indicating that the device split or detached during use.

Key Points: 
  • Teleflex initiated this voluntary recall on August 29, 2022 due to reports received indicating that the device split or detached during use.
  • Teleflex is currently issuing an expansion to this recall to include additional lots.
  • Teleflex requests that users immediately check their inventory for product within the scope of this recall.
  • On October 14, 2022, the U.S. Food and Drug Administration (FDA) classified the recall of Gibeck Iso-Gard Filters as a Class I recall.

SHAREHOLDER ALERT FILING DEADLINE TODAY: Pomerantz Law Firm Announces Reminds Shareholders with Losses on their Investment in Owlet, Inc. f/k/a Sandbridge Acquisition Corporation and Certain Officers – OWLT; OWLT WS; SBG

Retrieved on: 
Tuesday, January 18, 2022
Securities Exchange Act of 1934, Desaturation, SBG, News, Person, Pomerantz, Business architecture, Regulation of tobacco by the U.S. Food and Drug Administration, NYSE, Ext, Company, LLP, GLOBE, Lists of action films, Court, Health, Central District, Parent, Marketing, Lists of schools in England, OWLT, Complaint, Bradycardia, Food, FDA, Heart rate, Defendant, District court, Acquisition, Online gambling, Owlet

NEW YORK, Jan. 18, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Owlet, Inc. (Owlet or the Company) f/k/a Sandbridge Acquisition Corporation (Sandbridge) (NYSE: OWLT; OWLT WS; SBG) and certain of its officers.

Key Points: 
  • NEW YORK, Jan. 18, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Owlet, Inc. (Owlet or the Company) f/k/a Sandbridge Acquisition Corporation (Sandbridge) (NYSE: OWLT; OWLT WS; SBG) and certain of its officers.
  • Plaintiff pursues claims against the Defendants under the Securities Exchange Act of 1934 (the Exchange Act).
  • To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext.
  • Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.

Final Deadline Reminder: Kessler Topaz Meltzer & Check, LLP Reminds Investors of Lead Plaintiff Deadline in Securities Fraud Class Action Lawsuit Filed Against Owlet, Inc. (OWLT)

Retrieved on: 
Monday, January 17, 2022
Desaturation, SBG, Federal, News, Smart, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Infant, NYSE, LLP, GLOBE, Oxygen, Cosmetic, Central District, Federal Food, Drug, and Cosmetic Act, Parent, Marketing, OWLT, Bradycardia, Letter, FDA, Fraud, District court, Lead, Private investigator, Architecture, Food, Owlet

Kessler Topaz Meltzer & Check, LLP encourages Owlet investors who have suffered significant losses to contact the firm directly to acquire more information.

Key Points: 
  • Kessler Topaz Meltzer & Check, LLP encourages Owlet investors who have suffered significant losses to contact the firm directly to acquire more information.
  • The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel.
  • ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP
    Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country and around the world.
  • The complaint in this action was not filed by Kessler Topaz Meltzer & Check, LLP.

OWLET DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds Investors that a Class Action Lawsuit Has Been Filed Against Owlet, Inc. and Encourages Investors to Contact the Firm

Retrieved on: 
Monday, January 17, 2022
Legal, Professional Services, Desaturation, Telephone, Jeanne Eagels, News, Person, Business architecture, Regulation of tobacco by the U.S. Food and Drug Administration, NYSE, Court, Health, Central District, Parent, Marketing, Lists of schools in England, OWLT, Company, Advertising, Bradycardia, Food, P.C, FDA, Defendant, District court, Owlet

Investors have until January 18, 2022 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until January 18, 2022 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • On October 4, 2021, Owlet revealed that it had received a warning letter from the U.S. Food and Drug Administration (FDA), which stated that the Companys marketing of its Owlet Smart Sock product .
  • is a nationally recognized law firm with offices in New York, California, and South Carolina.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

Lead Plaintiff Deadline Approaching: Kessler Topaz Meltzer & Check, LLP Announces Deadline in Securities Fraud Class Action Lawsuit Filed Against Owlet, Inc.  

Retrieved on: 
Friday, January 14, 2022
Legal, Professional Services, Desaturation, SBG, Federal, News, Smart, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Infant, NYSE, LLP, Oxygen, Cosmetic, Federal Food, Drug, and Cosmetic Act, Parent, Marketing, OWLT, Bradycardia, Letter, FDA, Fraud, Lead, Private investigator, Food, Owlet

The law firm of Kessler Topaz Meltzer & Check, LLP informs investors that a securities class action lawsuit has been filed against Owlet, Inc. (Owlet) ( NYSE: OWLT ) f/k/a Sandbridge Acquisition Corp. (NYSE: SBG) (Sandbridge).

Key Points: 
  • The law firm of Kessler Topaz Meltzer & Check, LLP informs investors that a securities class action lawsuit has been filed against Owlet, Inc. (Owlet) ( NYSE: OWLT ) f/k/a Sandbridge Acquisition Corp. (NYSE: SBG) (Sandbridge).
  • The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel.
  • ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP
    Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country and around the world.
  • The complaint in this action was not filed by Kessler Topaz Meltzer & Check, LLP.