• Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Quantisnow Logo
  • Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Dashboard
    Quantisnow Logo

    © 2025 quantisnow.com
    Democratizing insights since 2022

    Services
    Live news feedsRSS FeedsAlerts
    Company
    AboutQuantisnow PlusContactJobs
    Legal
    Terms of usePrivacy policyCookie policy

    June 9, 2023 - FDA Roundup: June 9, 2023

    6/9/23 3:24:13 PM ET
    $DNOW
    Metal Fabrications
    Industrials
    Get the next $DNOW alert in real time by email
    For Immediate Release:
    June 09, 2023

    Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

    • Today, the FDA provided information to health care providers and facilities on oxygenator devices used in extracorporeal circulation. The FDA issued this letter to help ensure that health care providers and facilities are aware of a recall notice by Getinge/Maquet for Quadrox Oxygenators and have information about alternative devices. The Letter to Health Care Providers includes important information about this issue, including:
      • Recommendations for health care providers and facilities
      • Actions the FDA is taking to address the issue
      • How to contact the FDA if you are having any issues with oxygenators
    • On Thursday, the FDA approved an expanded indication for the Inspire Medical Systems’ Inspire Upper Airway Stimulation (UAS) System to include an updated apnea hypopnea index (AHI) and body mass index (BMI) threshold. The safety and effectiveness data available now increases the AHI baseline to 100 and a BMI level of 40 for adult patients with moderate to severe Obstructive Sleep Apnea (OSA). This device is an implantable nerve stimulator that detects the patient’s breathing pattern and maintains an open airway with mild stimulation of the nerves of the tongue. The patient, using a “remote control”- like device turns therapy on before sleep and turns therapy off on awakening. The UAS implant was initially approved in 2014 to treat certain patients, 22 years of age or older with moderate to severe OSA and in 2020, the indication was expanded to include certain adolescent patients between 18 and 21 years of age with moderate to severe OSA. In March, the indication was expanded to add certain pediatric patients, between 13 and 18 years of age, with Down syndrome and OSA.
    • On Thursday, the FDA updated the Medical Device Shortages List webpage. The updates include:
      • Devices that were removed from the medical device shortage list
        • Coil, Magnetic Resonance, Specialty, MRI breast biopsy grid plate only (product code: MOS)
        • Breast Biopsy / Localization Tray, MRI breast biopsy grid plate only (product code: PXP)
        • Guide, Needle, Surgical, MRI breast biopsy grid plate only (product code: GDF)
      • Devices with a change to estimated shortage duration 
        • Prefilled Saline Flush Syringes (product code: NGT) 
      • Devices that were discontinued
        • Some catalog numbers of one trade name of automatic external defibrillator (product code: MKJ)
        • Multiple trade names of Assisted Reproduction Labware - Testing Supplies & Equipment (product codes: MQK and PUD)

    For information about how the FDA determines it is appropriate to remove product codes from the device shortage list, please visit our webpage Supply and Shortages of Medical Devices: Frequently Asked Questions. In times when 506J notifications are not required, the FDA has more limited information about potential disruptions in the domestic supply of critical devices and has more limited ability to determine the extent and duration of shortages of critical devices.

    • On Monday, the FDA cleared for marketing the Elecsys Total-Tau Cerebral Spinal Fluid (CSF) and Elecsys ß-Amyloid (1-42) CSF II tests for the detection of amyloid plaques in patients aged 55 years and older being evaluated for Alzheimer’s disease (AD). Amyloid plaques are abnormal accumulations of β-amyloid in the spaces between nerve cells in the brain. The test is intended to be used in conjunction with other clinical diagnostic assessments to help health care providers determine whether a patient has AD. While a positive test result does not establish a diagnosis of AD or other cognitive disorder, a negative test result reduces the likelihood that a patient’s cognitive impairment is due to AD. The Elecsys CSF tests add to the increasing arsenal of clinical laboratory tests available to assist in the evaluation of patients with cognitive disorders such as AD.
    • This week, the FDA sent to Congress its Report on Drug Shortages for Calendar Year 2022, the tenth annual report, to summarize major actions taken by the agency to prevent or mitigate drug shortages in the United States. 2022 was a challenging year for shortages as manufacturers in the U.S. and abroad continue to experience quality issues and capacity constraints. The FDA also saw an additional strain on the pharmaceutical supply chain as demand increased for numerous drugs because of the COVID-19 pandemic combined with a challenging flu and respiratory virus season. Considering these challenges, the agency made a significant impact in helping to prevent or mitigate drug shortages. During CY 2022, there were 49 new shortages, and the FDA helped prevent 222 potential shortages.
    • On Tuesday and Wednesday, June 13-14, the FDA will host the 2023 Science Forum. This year’s forum, Advancing Regulatory Science Through Innovation, will feature talks from FDA science experts across the agency under 8 topics that highlight groundbreaking research that contributes to regulatory science discoveries. The virtual event will be kicked off by a keynote speech by Dr. Murray Lumpkin, Deputy Director of Integrated Development, Bill & Melinda Gates Foundation, and feature virtual poster sessions with downloadable content. The Science Forum is open to the public. To learn more about the program agenda and to register for the event, please visit the 2023 Science Forum web page.

    Related Information

    Related Information
    • FDA Newsroom

    ###

    Boilerplate

    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


    Inquiries

    Media:
    FDA Office of Media Affairs
    888-INFO-FDA
    Consumer:
    888-INFO-FDA

    Get the next $DNOW alert in real time by email

    Chat with this insight

    Save time and jump to the most important pieces.

    Recent Analyst Ratings for
    $DNOW

    DatePrice TargetRatingAnalyst
    7/8/2022$13.00Buy
    The Benchmark Company
    11/4/2021$12.00Equal-Weight → Overweight
    Stephens & Co.
    7/16/2021$12.00Hold → Buy
    Stifel
    More analyst ratings

    $DNOW
    Insider Trading

    Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

    See more
    • VP and General Counsel Chang Raymond W was granted 24,417 shares, increasing direct ownership by 8% to 319,944 units (SEC Form 4)

      4 - DNOW Inc. (0001599617) (Issuer)

      2/27/25 4:05:10 PM ET
      $DNOW
      Metal Fabrications
      Industrials
    • Officer Munson Kelly T. was granted 17,742 shares, increasing direct ownership by 14% to 142,925 units (SEC Form 4)

      4 - DNOW Inc. (0001599617) (Issuer)

      2/27/25 4:05:05 PM ET
      $DNOW
      Metal Fabrications
      Industrials
    • Officer Surratt Fanny R. was granted 8,873 shares, increasing direct ownership by 18% to 59,572 units (SEC Form 4)

      4 - DNOW Inc. (0001599617) (Issuer)

      2/27/25 4:05:03 PM ET
      $DNOW
      Metal Fabrications
      Industrials

    $DNOW
    Financials

    Live finance-specific insights

    See more

    $DNOW
    FDA approvals

    Live FDA approvals issued by the Food and Drug Administration and FDA breaking news

    See more
    • DNOW Reports First Quarter 2025 Results

      Earnings Conference Call May 7, 2025 8:00 a.m. CT 1 (888) 660-6431 (within North America) 1 (929) 203-2118 (outside North America) Access Code: 7372055 Webcast: ir.dnow.com DNOW Inc. (NYSE:DNOW) announced results for the first quarter ended March 31, 2025. Recent Capital Allocation Actions Repurchased $8 million of common stock in the first quarter of 2025, and $16 million year-to-date, under the $160 million share repurchase program authorized this year Completed acquisition of Natron International Pte. Ltd in April, headquartered in Singapore, which expands our electrical supply capabilities under the MacLean International brand in the Asia Pacific region, serving traditional and re

      5/7/25 6:45:00 AM ET
      $DNOW
      Metal Fabrications
      Industrials
    • DNOW Announces First Quarter 2025 Earnings Conference Call

      DNOW Inc. (NYSE:DNOW) has scheduled a conference call to discuss the results for the first quarter of 2025 on Wednesday, May 7, 2025 at 8:00 am (US Central Time). Financial results for the first quarter ending March 31, 2025 are expected to be released that morning before the market opens. The call will be broadcast through the Investor Relations link on DNOW's web site at ir.dnow.com on a listen-only basis. Listeners should log in prior to the start of the call to register for the webcast. A replay of the call will be available online for thirty days following the conference. Participants may also join the conference call by dialing 1-888-660-6431 within North America or 1-929-203-2118 ou

      4/24/25 6:45:00 AM ET
      $DNOW
      Metal Fabrications
      Industrials
    • DNOW Reports Fourth Quarter and Full-Year 2024 Results

      Earnings Conference Call February 13, 2025 8:00 a.m. CT 1 (800) 715-9871 (within North America) 1 (646) 307-1963 (outside North America) Access Code: 7372055 Webcast: ir.dnow.com DNOW Inc. (NYSE:DNOW) announced results for the fourth quarter and full-year ended December 31, 2024. Recent Capital Allocation Actions Announced a new $160 million share repurchase authorization, double the size of the share repurchase program successfully completed in 2024 Completed acquisition of Trojan Rentals, LLC in the fourth quarter of 2024, for $114 million in cash, enhancing our pump rental offering and industrial automation capabilities in the water transfer and management space Financial H

      2/13/25 6:45:00 AM ET
      $DNOW
      Metal Fabrications
      Industrials
    • December 15, 2023 - FDA Roundup: December 15, 2023

      For Immediate Release: December 15, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA updated the breast implants web pages to share the latest information on: Risks and complications related to breast implants  Reports of squamous cell carcinoma (SCC), various lymphomas other than Breast Implants Associated Anaplastic Large

      12/15/23 3:14:20 PM ET
      $DNOW
      Metal Fabrications
      Industrials
    • October 24, 2023 - FDA Roundup: October 24, 2023

      For Immediate Release: October 24, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Friday, the FDA approved Medtronic’s Aurora EV-ICD System for the treatment of patients who have experienced, or are at significant risk of developing, life-threatening abnormally fast heart rhythms (ventricular tachyarrhythmias). The system is composed of

      10/24/23 2:26:32 PM ET
      $DNOW
      Metal Fabrications
      Industrials
    • June 9, 2023 - FDA Roundup: June 9, 2023

      For Immediate Release: June 09, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA provided information to health care providers and facilities on oxygenator devices used in extracorporeal circulation. The FDA issued this letter to help ensure that health care providers and facilities are aware of a recall notice by Getinge/Maque

      6/9/23 3:24:13 PM ET
      $DNOW
      Metal Fabrications
      Industrials

    $DNOW
    Press Releases

    Fastest customizable press release news feed in the world

    See more
    • DNOW Reports First Quarter 2025 Results

      Earnings Conference Call May 7, 2025 8:00 a.m. CT 1 (888) 660-6431 (within North America) 1 (929) 203-2118 (outside North America) Access Code: 7372055 Webcast: ir.dnow.com DNOW Inc. (NYSE:DNOW) announced results for the first quarter ended March 31, 2025. Recent Capital Allocation Actions Repurchased $8 million of common stock in the first quarter of 2025, and $16 million year-to-date, under the $160 million share repurchase program authorized this year Completed acquisition of Natron International Pte. Ltd in April, headquartered in Singapore, which expands our electrical supply capabilities under the MacLean International brand in the Asia Pacific region, serving traditional and re

      5/7/25 6:45:00 AM ET
      $DNOW
      Metal Fabrications
      Industrials
    • EnerCom Opens Registration for the 30th Annual EnerCom Denver - The Energy Investment Conference

      Join us as we celebrate three decades of bringing together the energy industry's companies, investors, analysts, and industry leaders! Investors are encouraged to register for EnerCom Denver – The Energy Investment Conference featuring a broad group of public and private energy companies at www.enercomdenver.com  A robust list of companies has confirmed their participation, and more are being added daily   Sponsorship opportunities are available for companies seeking to increase marketplace and brand awareness through EnerCom's multi-digital approach before, during, and after each event DENVER, April 29, 2025 /PRNewswire/ -- EnerCom, Inc. today opened registration for its 30th annual EnerCo

      4/29/25 1:17:00 PM ET
      $AMPY
      $BKV
      $BRY
      $BTE
      Oil & Gas Production
      Energy
      Metal Fabrications
      Industrials
    • DNOW Announces First Quarter 2025 Earnings Conference Call

      DNOW Inc. (NYSE:DNOW) has scheduled a conference call to discuss the results for the first quarter of 2025 on Wednesday, May 7, 2025 at 8:00 am (US Central Time). Financial results for the first quarter ending March 31, 2025 are expected to be released that morning before the market opens. The call will be broadcast through the Investor Relations link on DNOW's web site at ir.dnow.com on a listen-only basis. Listeners should log in prior to the start of the call to register for the webcast. A replay of the call will be available online for thirty days following the conference. Participants may also join the conference call by dialing 1-888-660-6431 within North America or 1-929-203-2118 ou

      4/24/25 6:45:00 AM ET
      $DNOW
      Metal Fabrications
      Industrials

    $DNOW
    Leadership Updates

    Live Leadership Updates

    See more

    $DNOW
    SEC Filings

    See more

    $DNOW
    Large Ownership Changes

    This live feed shows all institutional transactions in real time.

    See more
    • Borets International rebrands to Levare International and announces appointment of new Chief Executive Officer and Chairman

      DUBAI, UAE, May 8, 2023 /PRNewswire/ -- Borets International Limited, a global leader in artificial lift engineering, manufacturing, sales, and servicing of electric submersible pumps (ESP), announced the growing and evolving Company has undergone restructuring to reach this exciting juncture where the international business is a distinct and separate division. Accordingly, the rebranding of the company to Levare International Limited (Levare or Company) better aligns with the forward-thinking mindset of new leadership.  This change reflects our growing portfolio of artificial lift solutions offered to our global clients within the oil & gas, mining, geothermal and municipal industries.

      5/8/23 8:23:00 AM ET
      $DNOW
      $NOV
      $RIG
      Metal Fabrications
      Industrials
      Oil & Gas Production
      Energy
    • NOW Inc. Announces Appointment of Karen David-Green to the Board of Directors

      NOW Inc. (NYSE:DNOW) announced today that Karen David-Green has been appointed to the Company's Board of Directors effective March 24, 2023. Ms. David-Green's term will expire at the 2023 annual stockholders' meeting. Ms. David-Green has served as the Chief Communications, Stakeholder and Sustainability Officer at Expro Group, a publicly traded company listed on the New York Stock Exchange, since 2021. Prior to joining Expro Group, Ms. David-Green was part of Weatherford International plc for ten years, where she last served as Senior Vice President, Stakeholder Engagement & Chief Marketing Officer. Prior to joining the energy industry, Ms. David-Green spent 15 years on Wall Street, where

      3/27/23 6:45:00 AM ET
      $DNOW
      Metal Fabrications
      Industrials
    • NOW Inc. Announces Appointment of Sonya Reed to the Board of Directors

      NOW Inc. (NYSE:DNOW) announced today that Sonya Reed has been appointed to the Company's Board of Directors effective August 11, 2021. Ms. Reed's term will expire at the 2022 annual stockholders' meeting. Ms. Reed has served as the Senior Vice President of Human Resources and Corporate Communications of Phillips 66, a publicly traded company listed on the New York Stock Exchange, since 2015. From 2011 to 2015, Ms. Reed was with General Cable, where she last served as Executive Vice President, Chief Human Resources Officer. Ms. Reed began her career at Zurich Financial Services, where she held several positions of increasing responsibility, the last of which was Vice President of Human Reso

      8/12/21 6:45:00 AM ET
      $DNOW
      Metal Fabrications
      Industrials
    • SEC Form 10-Q filed by DNOW Inc.

      10-Q - DNOW Inc. (0001599617) (Filer)

      5/7/25 3:07:35 PM ET
      $DNOW
      Metal Fabrications
      Industrials
    • DNOW Inc. filed SEC Form 8-K: Results of Operations and Financial Condition

      8-K - DNOW Inc. (0001599617) (Filer)

      5/7/25 6:57:42 AM ET
      $DNOW
      Metal Fabrications
      Industrials
    • SEC Form DEFA14A filed by DNOW Inc.

      DEFA14A - DNOW Inc. (0001599617) (Filer)

      4/4/25 9:07:10 AM ET
      $DNOW
      Metal Fabrications
      Industrials
    • SEC Form SC 13G/A filed by NOW Inc. (Amendment)

      SC 13G/A - DNOW Inc. (0001599617) (Subject)

      2/13/24 5:09:44 PM ET
      $DNOW
      Metal Fabrications
      Industrials
    • SEC Form SC 13G/A filed by NOW Inc. (Amendment)

      SC 13G/A - DNOW Inc. (0001599617) (Subject)

      2/9/24 9:59:03 AM ET
      $DNOW
      Metal Fabrications
      Industrials
    • SEC Form SC 13G/A filed by NOW Inc. (Amendment)

      SC 13G/A - DNOW Inc. (0001599617) (Subject)

      1/22/24 2:03:07 PM ET
      $DNOW
      Metal Fabrications
      Industrials

    $DNOW
    Analyst Ratings

    Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

    See more
    • The Benchmark Company initiated coverage on Now with a new price target

      The Benchmark Company initiated coverage of Now with a rating of Buy and set a new price target of $13.00

      7/8/22 7:15:53 AM ET
      $DNOW
      Metal Fabrications
      Industrials
    • NOW upgraded by Stephens & Co. with a new price target

      Stephens & Co. upgraded NOW from Equal-Weight to Overweight and set a new price target of $12.00

      11/4/21 7:03:09 AM ET
      $DNOW
      Metal Fabrications
      Industrials
    • NOW upgraded by Stifel with a new price target

      Stifel upgraded NOW from Hold to Buy and set a new price target of $12.00

      7/16/21 4:55:30 AM ET
      $DNOW
      Metal Fabrications
      Industrials