Federal Food, Drug, and Cosmetic Act

Atea Pharmaceuticals Announces U.S. FDA Fast Track Designation Granted to AT-752 for Treatment of Dengue

Retrieved on: 
Monday, September 26, 2022
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BOSTON, Sept. 26, 2022 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to AT-752, a novel, orally administered, direct-acting antiviral for the treatment of dengue virus infection.

Key Points: 
  • AT-752, a novel, orally administered direct-acting antiviral derived from Ateas purine nucleotide prodrug platform was designed for the treatment and prophylaxis of dengue.
  • Dengue is the most prevalent mosquito-borne virus affecting up to 400 million people annually and is a substantial public health and economic burden worldwide.
  • Dengue causes a severe generalized illness with fever which may require hospitalization and is associated with mortality.
  • The FDA, together with other governmental and non-governmental agencies, recognize dengue as a substantial and growing global public health burden.

The Alternative to Foam Negative Pressure Wound Therapy Is Cleared by the FDA

Retrieved on: 
Friday, September 23, 2022
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Boston, Massachusetts--(Newsfile Corp. - September 23, 2022) - Applied Tissue Technologies (ATT), an advanced wound care company, announced the 510k clearance by the FDA today of its Platform Wound Dressing "PWD(R)" Negative Pressure Wound Therapy "NPWT" System.

Key Points: 
  • Boston, Massachusetts--(Newsfile Corp. - September 23, 2022) - Applied Tissue Technologies (ATT), an advanced wound care company, announced the 510k clearance by the FDA today of its Platform Wound Dressing "PWD(R)" Negative Pressure Wound Therapy "NPWT" System.
  • This clearance pairs ATT's revolutionary embossed dressing with a purpose built pump developed from the ground up for use with this dressing.
  • To view the full announcement, including downloadable images, bios, and more, click here .
  • Eliminating Foam and Gauze Wound Fillers in Negative Pressure Wound Therapy Dressings Simplifies Treatment and avoids complications related to foam and gauze.

'iSyncWave' EEG Scanner receives FDA 510k clearance

Retrieved on: 
Friday, September 23, 2022
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SEOUL, South Korea, Sept. 23, 2022 /PRNewswire/ -- iMediSync announced that iSyncWave, the company's medical device EEG scanner, hasbeen granted 510k clearance from the US Food and Drug Administration (FDA) on August 10th.

Key Points: 
  • SEOUL, South Korea, Sept. 23, 2022 /PRNewswire/ -- iMediSync announced that iSyncWave, the company's medical device EEG scanner, hasbeen granted 510k clearance from the US Food and Drug Administration (FDA) on August 10th.
  • According to iMediSync, iSyncWave is a dry EEG scanner that does not require the use ofelectrode gel.
  • Following the FDA 510k clearance, iMediSync plans to increase and expand overseas sales.
  • With FDA 510k clearance, we can provide product information and conduct collaborative research to sell iSyncWave.

New Ambient Computing Breakthrough From Wiliot to Enable the Massive IoT, as 6G Standards Are Set to Define the Future of Telecommunications

Retrieved on: 
Thursday, September 22, 2022
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SAN DIEGO, Sept. 22, 2022 /PRNewswire/ -- Wiliot, the Internet of Things pioneer whose IoT platform is enabling trillions of "things" to gain intelligence, will premier its breakthrough ambient computing technology – the Wiliot IoT Pixel – to the telecommunications industry at MWC 2022 from September 28 through September 30 at Wiliot Booth #W2.1138.

Key Points: 
  • Wiliot, along with other IoT and telecommunications leaders, are creating a new, fully scaled Massive IoT, or internet of trillions of things, that will leverage ambient computing to connect nearly everything to the internet.
  • Doing so will address some of the world's biggest problems across supply chain efficiency, food & drug safety, and planetary sustainability.
  • At MWC 2022 Wiliot will forecast the future of an ambient-powered, 6G-enabled Massive IoT in a presentation titled " 6G Ambient Computing Intro: Antidote to Supply Chain & Climate Crises?
  • ", which will be delivered with ABI Research and other key 6G and IoT leaders.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Outset Medical, Missfresh, and Stitch Fix and Encourages Investors to Contact the Firm

Retrieved on: 
Wednesday, September 7, 2022
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Outset Medical is a medical technology company focused on kidney dialysis, the primary treatment for acute and chronic kidney failure.

Key Points: 
  • Outset Medical is a medical technology company focused on kidney dialysis, the primary treatment for acute and chronic kidney failure.
  • In truth, throughout the Class Period, Stitch Fix concealed the fact that these programs were not complementary or additive.
  • For more information on theStitch Fix class action go to: https://bespc.com/cases/SFIX
    About Bragar Eagel & Squire, P.C.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

Irwin Naturals Emergence to Add Ohio Ketamine Clinic

Retrieved on: 
Tuesday, September 6, 2022
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State CSAs have either adopted drug schedulesidentical or similar to the federal CSA schedules or, in some instances, have incorporatedthe federal scheduling mechanism.

Key Points: 
  • State CSAs have either adopted drug schedulesidentical or similar to the federal CSA schedules or, in some instances, have incorporatedthe federal scheduling mechanism.
  • In the United States, facilities holding or administering controlled substances must beregistered with the US Drug Enforcement Agency ("DEA") to perform this activity.
  • Licensed medical practitioners may prescribe ketamine legally inCanada or the United States where they believe it will be an effective treatment in theirprofessional judgment.
  • 2 Under several corporate structures, Klee Irwin has operated the Irwin brand profitably since 1994, as measured by EBITDA adjusted for extraordinary costs.

GenBody America Receives Amendment to FDA Emergency Use Authorization for Updated Point-of-Care Test Kits with Individual Reagents

Retrieved on: 
Thursday, September 1, 2022
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Were very pleased that the FDA has amended our authorizations, said David Yoo, CEO of Genbody America.

Key Points: 
  • Were very pleased that the FDA has amended our authorizations, said David Yoo, CEO of Genbody America.
  • Were proud to offer a new level of accessibility with our point-of-care kits that equips our customers with individual reagents.
  • GenBody America is the U.S. manufacturer for GenBody, Inc. , a leading South Korean manufacturer of rapid diagnostic tests and reagents for point-of-care applications for COVID-19 and other diseases.
  • The GenBody COVID-19 Ag Test has been authorized by the FDA under an EUA for use by authorized laboratories, pending full FDA clearance.

Cue Health Makes De Novo Submission to FDA for Full Clearance of its Cue® Flu Molecular Test

Retrieved on: 
Thursday, September 1, 2022
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FDA clearance of Cue's test would provide the public, for the first time, an at-home and POC molecular flu test that has been fully reviewed by the FDA for safety and effectiveness.

Key Points: 
  • FDA clearance of Cue's test would provide the public, for the first time, an at-home and POC molecular flu test that has been fully reviewed by the FDA for safety and effectiveness.
  • Clinical study results with the Cue Flu Molecular Test were favorable, demonstrating 99% accuracy1compared to FDA cleared molecular (PCR) laboratory tests for influenza A&B.
  • The Cue Flu Molecular Test cartridge uses a lower nasal swab and is compatible with the Cue Reader, which communicates test results digitally via Bluetooth to a mobile device in approximately 25 minutes.
  • "This FDA submission for our Cue Flu Molecular Test is another important milestone on Cue's path to pioneer a new approach to diagnostics in homes, enterprises, and healthcare settings," said Ayub Khattak, Chairman and CEO of Cue Health.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Unity, Amazon, Outset Medical, and Missfresh and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, September 1, 2022
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On this news, Unitys stock price fell $17.83 per share, or approximately 37%, to close at $30.30 per share on May 11, 2022.

Key Points: 
  • On this news, Unitys stock price fell $17.83 per share, or approximately 37%, to close at $30.30 per share on May 11, 2022.
  • The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Companys business, operations, and compliance policies.
  • For more information on the Missfresh class action go to: https://bespc.com/cases/MF
    About Bragar Eagel & Squire, P.C.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

HAGENS BERMAN, NATIONAL TRIAL ATTORNEYS, Encourages Outset Medical (OM) Investors with Over $300,000 Losses to Contact the Firm’s Attorneys Before Sept. 6th Deadline in Securities Fraud Class Action

Retrieved on: 
Monday, August 29, 2022
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This news drove the price of Outset Medical shares sharply lower.

Key Points: 
  • This news drove the price of Outset Medical shares sharply lower.
  • If you invested in Outset and have significant losses, or have knowledge that may assist the firms investigation, click here to discuss your legal rights with Hagens Berman .
  • Whistleblowers: Persons with non-public information regarding Outset should consider their options to help in the investigation or take advantage of the SEC Whistleblower program.
  • Hagens Berman is a global plaintiffs rights complex litigation law firm focusing on corporate accountability through class-action law.