Federal Food, Drug, and Cosmetic Act

OM INVESTOR ALERT: Hagens Berman, National Trial Attorneys, Encourages Outset Medical (OM) Investors with Over $300,000 Losses to Contact the Firm’s Attorneys, Securities Fraud Class Action Pending

Retrieved on: 
Thursday, August 18, 2022 - 8:22pm

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.

Spectral Announces FDA Approval to Add Up to 10 Additional Tigris Clinical Trial Sites

Retrieved on: 
Thursday, August 18, 2022 - 1:00pm

This approval would bring the total potential trial sites to 25 U.S. institutions.

Key Points: 
  • This approval would bring the total potential trial sites to 25 U.S. institutions.
  • Chris Seto, Chief Executive Officer of Spectral, commented, We are pleased to receive FDA approval to increase our Tigris clinical trial sites, which should support more rapid enrollment.
  • Our goal is to add at least four additional clinical trial sites by the end of October 2022.
  • Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin (PMX).

Independent Study Shows Cue Health's Molecular COVID-19 Test is as Accurate as a Lab-Based PCR Test

Retrieved on: 
Wednesday, August 17, 2022 - 9:15pm

SAN DIEGO, Calif., Aug. 17, 2022 /PRNewswire/ -- Cue Health Inc. ("Cue") (Nasdaq: HLTH) announced today the preprint publication of an independent clinical study - the largest of its kind on asymptomatic people - demonstrating that its point of care (POC) molecular COVID-19 test, which produces results in approximately 20 minutes, is as accurate as a centralized lab-based RT-PCR.  

Key Points: 
  • The study presents findings from a head-to-head comparison of the Cue COVID-19 test against lab-based RT-PCR on paired samples from 3,037 individuals.
  • "The findings from our large study indicate that sensitivity of Cue's POC testing may be an excellent proxy for PCR when accurate and fast results are urgently needed to curb transmission."
  • Specimen collection and Cue COVID-19 testing was performed by trained registered nurses (RNs and RPNs) at FH Health clinic sites.
  • Cue Health's first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription and physician supervision.

Preparing for Continuing Battle with COVID, MicroGEM Partners with Medline to Equip Healthcare Providers with World's First Saliva PCR Test for Point of Care

Retrieved on: 
Wednesday, August 17, 2022 - 7:10pm

CHARLOTTESVILLE, Va., Aug. 17, 2022 /PRNewswire/ -- MicroGEM, a U.S.-based molecular biology company, today announced that Medline, a manufacturer and distributor of medical supplies to healthcare providers across the continuum of care, is now offering the MicroGEM Sal6830 Point of Care PCR System and SARS-CoV-2 Saliva Test.

Key Points: 
  • "Our partnership with MicroGEM expands our product portfolio to offer a saliva-based test for the first time.
  • Medline is a healthcare company; a manufacturer, distributor, and solutions provider focused on improving the overall operating performance of healthcare.
  • Partnering with healthcare systems and facilities across the continuum of care, Medline provides the clinical and supply chain resources required for long-term financial viability in delivering high-quality care.
  • Headquartered in Northfield, Ill., Medline has 30,000+ employees worldwide and does business in more than 125 countries and territories.

TransMed7, LLC Announces First Clinical Use of Heron Soft Tissue Biopsy Devices for Commercial Launch

Retrieved on: 
Tuesday, August 16, 2022 - 12:00pm

The whole biopsy procedure was finished in less than 5 minutes, which represents a significant cost savings as well.

Key Points: 
  • The whole biopsy procedure was finished in less than 5 minutes, which represents a significant cost savings as well.
  • The Heron platform of soft tissue biopsy devices includes three models of hand-held, ultrasound guided, vacuum assisted, full fluid management, SIMC devices.
  • The Heron XPK and XPS full featured models are designed for manual coring length control and automatic tissue transport.
  • The Heron platform devices will provide the most advanced capabilities for biopsy devices featuring needle sizes from 12 to 18 gauge.

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

Retrieved on: 
Thursday, August 11, 2022 - 2:00am

On June 6, 2022, Reuters published an article entitled Wells Fargo Pauses Diverse Slate Hiring Policy after Reports of Fake Job Interviews.

Key Points: 
  • On June 6, 2022, Reuters published an article entitled Wells Fargo Pauses Diverse Slate Hiring Policy after Reports of Fake Job Interviews.
  • Then, on June 9, 2022, the New York Times published an article entitled Federal Prosecutors Open Criminal Inquiry of Wells Fargos Hiring Practices.
  • For more information on the Wells Fargo class action go to: https://bespc.com/cases/WFC
    Unity creates and operates an interactive real-time 3D content platform.
  • For more information on the Outset Medical class action go to: https://bespc.com/cases/OM
    About Bragar Eagel & Squire, P.C.

HAGENS BERMAN, NATIONAL TRIAL ATTORNEYS, Encourages Outset Medical (OM) Investors with Over $300,000 Losses to Contact the Firm’s Attorneys, Securities Fraud Class Action Pending

Retrieved on: 
Tuesday, August 9, 2022 - 7:25pm

SAN FRANCISCO, Aug. 09, 2022 (GLOBE NEWSWIRE) -- Hagens Berman urges Outset Medical, Inc. (NASDAQ: OM) investors who have suffered over $300,000 losses to submit your losses now .

Key Points: 
  • SAN FRANCISCO, Aug. 09, 2022 (GLOBE NEWSWIRE) -- Hagens Berman urges Outset Medical, Inc. (NASDAQ: OM) investors who have suffered over $300,000 losses to submit your losses now .
  • Were focused on recovering investors losses and proving Defendants misled investors about Outsets FDA clearance for Tablo and its adherence to FDA-approved protocols, said Reed Kathrein, the Hagens Berman partner leading the investigation.
  • 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 .
  • Hagens Berman is a global plaintiffs rights complex litigation law firm focusing on corporate accountability through class-action law.

FDA Issues Warning Letters to Three Companies for Selling Unapproved New Drugs for Mole and Skin Tag Removal

Retrieved on: 
Tuesday, August 9, 2022 - 3:42pm

SILVER SPRING, Md., Aug. 9, 2022 /PRNewswire/ -- Today, the U.S. Food and Drug Administration announced it issued three warning letters to companies for introducing mole and skin tag removal products into interstate commerce that are unapproved new drugs, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). There are no FDA-approved over-the-counter drug products for the removal of moles and skin tags.

Key Points: 
  • There are no FDA-approved over-the-counter drug products for the removal of moles and skin tags.
  • "The agency's rigorous surveillance works to identify threats to public health and stop these products from reaching our communities.
  • This includes where online retailers like Amazon are involved in the interstate sale of unapproved drug products.
  • The FDA has issued a consumer warning noting that products marketed for removing moles and other skin lesions can cause injuries and scarring.

Spectral Medical Announces that its Wholly-Owned Subsidiary Dialco Medical and Distribution Partner Marathon Medical Awarded Contract to Provide SAMI Dialysis Devices to the US Department of Veterans Affairs

Retrieved on: 
Monday, August 8, 2022 - 1:00pm

The United States Department of Veterans Affairs is a government agency responsible for providing healthcare and other services to veterans.

Key Points: 
  • The United States Department of Veterans Affairs is a government agency responsible for providing healthcare and other services to veterans.
  • SAMI also provides clear visuals with an easy-to-read display and rapid set up, which reduces the burden on healthcare staff.
  • We believe the receipt of this contract award is an important milestone towards accelerating the commercial rollout of our SAMI device.
  • Jon Landis, Chief Operating Officer of Marathon, stated, We are excited to partner with Dialco to improve healthcare outcomes for Americas veterans.

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

Retrieved on: 
Saturday, August 6, 2022 - 2:00am

On June 6, 2022, Reuters published an article entitled Wells Fargo Pauses Diverse Slate Hiring Policy after Reports of Fake Job Interviews.

Key Points: 
  • On June 6, 2022, Reuters published an article entitled Wells Fargo Pauses Diverse Slate Hiring Policy after Reports of Fake Job Interviews.
  • Then, on June 9, 2022, the New York Times published an article entitled Federal Prosecutors Open Criminal Inquiry of Wells Fargos Hiring Practices.
  • For more information on the Wells Fargo class action go to: https://bespc.com/cases/WFC
    Unity creates and operates an interactive real-time 3D content platform.
  • For more information on the Outset Medical class action go to: https://bespc.com/cases/OM
    About Bragar Eagel & Squire, P.C.