Colonoscopy

FDA Authorizes Marketing of MAGENTIQ-COLO™, a Cutting-Edge AI Gastrointestinal Lesion Software Detection System that Helps Detect Lesions in Real Time During Colonoscopy Procedures

Retrieved on: 
Monday, July 31, 2023

HAIFA, Israel, July 31, 2023 /PRNewswire/ -- MAGENTIQ-EYE LTD., an Israeli-based technology company founded in 2014, announced today that the U.S. Food and Drug Administration (FDA) has cleared the MAGENTIQ-COLO™ via the 510(k) process. The device, which offers the gastroenterology community and its patients a significant increase in Adenoma Detection Rate (ADR), will be available in the United States in the coming weeks. The FDA clearance comes on the heels of the European CE Mark and Israel AMAR approval, which were received in mid-2021, opening doors to one of the most significant markets for this category of medical devices.

Key Points: 
  • The device, which offers the gastroenterology community and its patients a significant increase in Adenoma Detection Rate (ADR), will be available in the United States in the coming weeks.
  • To download photos of the MAGENTIQ-COLO™ solution, click here and here .
  • According to the National Institutes of Health (NIH), colorectal cancer (CRC) ranks as the third-leading cause of cancer-related death in the United States.
  • MAGENTIQ-COLO™ will be marketed in the U.S. through a local subsidiary and a network of agents that is now being established.

Terry Crews and His Creative Company Super Serious Join Ryan Reynolds’ Maximum Effort and the Colorectal Cancer Alliance to ‘LEAD FROM BEHIND’

Retrieved on: 
Tuesday, July 25, 2023

The nation’s leading nonprofit dedicated to colon cancer, the Colorectal Cancer Alliance (Alliance) is reteaming with Ryan Reynolds’ creative agency, Maximum Effort, to reignite LEAD FROM BEHIND, featuring Terry Crews to kick-off the effort.

Key Points: 
  • The nation’s leading nonprofit dedicated to colon cancer, the Colorectal Cancer Alliance (Alliance) is reteaming with Ryan Reynolds’ creative agency, Maximum Effort, to reignite LEAD FROM BEHIND, featuring Terry Crews to kick-off the effort.
  • Colon cancer is the second deadliest cancer in the U.S., yet it is highly preventable with timely screening.
  • “I’ve partnered with the Colorectal Cancer Alliance and LEAD FROM BEHIND because together we can prevent unnecessary suffering from The Preventable Cancer,” said Terry Crews.
  • That’s why colon cancer is The Preventable Cancer,” said Michael Sapienza, CEO of the Colorectal Cancer Alliance.

Motus GI Announces Purchase Agreement for the Pure-Vu System® from Banner Desert Medical Center

Retrieved on: 
Thursday, July 20, 2023

Banner Desert Medical Center is a state-of-the-art 615-bed short-term acute care hospital located in Mesa, Arizona.

Key Points: 
  • Banner Desert Medical Center is a state-of-the-art 615-bed short-term acute care hospital located in Mesa, Arizona.
  • Dr. Mankanwal Sachdev, Director of Endoscopy at Banner Desert Medical Center stated, “The Banner Desert Medical Center prides itself for adopting new technologies that allow us to provide the best care possible to our patients.
  • We believe the Pure-Vu System will provide us unique capabilities that support completing procedures for patients with incomplete bowel preparation.
  • Also, as a level I trauma center, we are excited about the future expansion of the platform to help address Upper GI bleeding which can be a life threating clinical concern.”
    “We are excited to engage the GI team at Banner Desert Medical Center as they implement the Pure-Vu System.

FDA Approves Sebela Pharmaceuticals' SUFLAVE™ A New Colonoscopy Preparation that Tastes Similar to a Sports Drink

Retrieved on: 
Thursday, June 22, 2023

BRAINTREE, Mass., June 22, 2023 /PRNewswire/ -- Sebela Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) granted approval of SUFLAVE™ (polyethylene glycol, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution), for colonoscopy preparation in adults. SUFLAVE, a low-volume, safe and effective colonoscopy preparation – with a taste similar to a lemon-lime sports drink – was developed and will be marketed by Braintree Laboratories, a leader in gastroenterology and part of Sebela Pharmaceuticals.

Key Points: 
  • SUFLAVE, a low-volume, safe and effective colonoscopy preparation – with a taste similar to a lemon-lime sports drink – was developed and will be marketed by Braintree Laboratories, a leader in gastroenterology and part of Sebela Pharmaceuticals.
  • Additionally, colonoscopy preparation products and processes are commonly cited as a significant patient barrier to colon cancer screening,v reinforcing an unmet need among patients for better bowel preparation options.
  • The majority of patients reported that SUFLAVE tastes like a sports drink, and 79% of patients found the taste neutral to very pleasant compared to SUPREP (54%).
  • Administration of two doses of SUFLAVE are required for a complete preparation for colonoscopy.

Medtronic Recognized for Artificial Intelligence Innovation in 2023 AI Breakthrough Awards Program

Retrieved on: 
Wednesday, June 21, 2023

LOS ANGELES, June 21, 2023 /PRNewswire-PRWeb/ -- AI Breakthrough, a leading market intelligence organization that recognizes the top companies, technologies and products in the global Artificial Intelligence (AI) market, today announced that Medtronic plc, the leading global healthcare technology company, has been selected as winner of the "Best Deep Learning Platform" award in the sixth annual AI Breakthrough Awards program, recognizing the breakthrough innovation of Medtronic's GI Genius™ system.

Key Points: 
  • LOS ANGELES, June 21, 2023 /PRNewswire-PRWeb/ -- AI Breakthrough , a leading market intelligence organization that recognizes the top companies, technologies and products in the global Artificial Intelligence (AI) market, today announced that Medtronic plc , the leading global healthcare technology company, has been selected as winner of the "Best Deep Learning Platform" award in the sixth annual AI Breakthrough Awards program, recognizing the breakthrough innovation of Medtronic's GI Genius™ system.
  • GI Genius is the first FDA authorized computer-aided detection (CADe) system using AI to help endoscopists identify colorectal polyps, regardless of shape, size, or morphology.
  • Our expanding AI capabilities at Medtronic create opportunities to deliver against unmet needs, including across the Gastrointestinal (GI) practice."
  • However, colonoscopy is difficult, and polyps may be difficult to find," said James Johnson, managing director, AI Breakthrough.

Digestive Health Center Joins GI Alliance

Retrieved on: 
Wednesday, June 21, 2023

DALLAS , June 21, 2023 /PRNewswire/ -- GI Alliance, the nation's premier gastroenterology management organization, is excited to announce a partnership with Digestive Health Center in Ocean Springs, expanding GI Alliance's presence in Mississippi.

Key Points: 
  • DALLAS , June 21, 2023 /PRNewswire/ -- GI Alliance , the nation's premier gastroenterology management organization, is excited to announce a partnership with Digestive Health Center in Ocean Springs, expanding GI Alliance's presence in Mississippi.
  • Digestive Health Center includes four office locations with four physicians, seven nurse practitioners, a registered dietitian, and 50 team members.
  • "This partnership with Digestive Health Center in Ocean Springs is a great addition to our existing Jackson and Hattiesburg practices providing services to Mississippi and the gulf coast region," said James Weber, M.D., CEO of GI Alliance.
  • "Digestive Health Center will immediately benefit from GI Alliance's Jackson-based operations and infrastructure."

Next-generation Cologuard Test Demonstrates 94 Percent Sensitivity for Colorectal Cancer at 91 Percent Specificity, Raising the Bar in Non-invasive Screening

Retrieved on: 
Tuesday, June 20, 2023

MADISON, Wis., June 20, 2023 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced positive top-line results from the pivotal BLUE-C study. The results show that next-generation Cologuard® met all study endpoints and improved every top-line metric, including a 30 percent lower false positive rate, when compared to DeeP-C, the FDA registrational trial for Cologuard.

Key Points: 
  • Note: specificity including non-advanced findings includes colonoscopy results that were negative for cancer or advanced precancer upon histopathological review; specificity including no findings includes no findings on colonoscopy and no histopathological review; high-grade dysplasia includes carcinoma in situ and stage 0 cancer
    "Cologuard is a groundbreaking innovation in non-invasive cancer detection.
  • Next-generation Cologuard will set a new performance standard," said Kevin Conroy, chairman and CEO of Exact Sciences.
  • "We are harnessing deep scientific insights, advanced technology, and over a decade of research and development to detect colorectal cancer with greater sensitivity and significantly improve the false positive rate.
  • Once approved, next-generation Cologuard will meaningfully enhance the patient experience, and it comes at a critical time – when there are 60 million Americans not up to date with screening."

Long COVID could be caused by the virus lingering in the body. Here's what the science says

Retrieved on: 
Saturday, June 10, 2023

When symptoms last longer than 12 weeks, the condition is known as long COVID.

Key Points: 
  • When symptoms last longer than 12 weeks, the condition is known as long COVID.
  • Long COVID encompasses up to 200 different symptoms.
  • One factor that may be associated with long COVID is that the virus hasn’t fully cleared from the body after the initial infection.

Other viruses lurk in the body

    • This means the virus conceals itself within cells and remains dormant.
    • HIV, in particular, can remain dormant in infected cells throughout the body.
    • Several studies have shown COVID can also reactivate the Epstein-Barr virus, which has remained in the body in a latent state.

How do we know COVID stays in the body?

    • SARS-CoV-2 RNA was detected in at least half the samples of heart, lymph glands, eye, nerve, brain and lung tissue tested.
    • These patients had asymptomatic COVID and were PCR-negative from swabs of the nose and throat at four months.
    • Initial studies did not always suggest a strong relationship between the long-term detection of SARS-CoV-2 and long COVID symptoms.

How might the delay in clearing the virus impact people with long COVID?

    • We have previously shown immune dysfunction and inflammation persist up to eight months in people with long COVID that initially had mild to moderate disease.
    • Read more:
      When does COVID become long COVID?
    • Antibodies reactive to Epstein-Barr virus are elevated in people with long COVID suggesting Epstein-Barr virus reactivation, likely through activating the immune system.
    • This should include examination of viral RNA and protein in both blood and tissues in people with long COVID independent of disease severity.

EQS-News: Mainz Biomed Expands Commercial Footprint into Poland

Retrieved on: 
Thursday, June 1, 2023

BERKELEY, US – MAINZ, Germany – May 31, 2023 — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the establishment of a commercial partnership for ColoAlert® with TESTDNA Sp.

Key Points: 
  • BERKELEY, US – MAINZ, Germany – May 31, 2023 — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the establishment of a commercial partnership for ColoAlert® with TESTDNA Sp.
  • “Entering the Polish market is an important milestone for the Company and we are thrilled by the opportunity to partner with TESTDNA to establish ColoAlert’s commerical footprint in this territory,” commented Darin Leigh, Chief Commercial Officer of Mainz Biomed.
  • Mainz Biomed is providing ColoAlert to TESTDNA under the standard terms of the Company’s partnership agreements.
  • In the coming weeks, Mainz Biomed will work with TESTDNA to prepare and launch co-marketing activities to ensure successful commercialization in the Polish market.

Mainz Biomed Expands Commercial Footprint into Poland

Retrieved on: 
Wednesday, May 31, 2023

BERKELEY, Calif. and MAINZ, Germany, May 31, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the establishment of a commercial partnership for ColoAlert® with TESTDNA Sp. z o.o. Sp. k. Katowice, Poland, a leading independent laboratory in Poland. ColoAlert is Mainz Biomed’s flagship product, a highly efficacious and easy to use, at-home detection test for colorectal cancer (CRC) currently being commercialized across Europe and in select international markets via a differentiated business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility.

Key Points: 
  • BERKELEY, Calif. and MAINZ, Germany, May 31, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the establishment of a commercial partnership for ColoAlert® with TESTDNA Sp.
  • “Entering the Polish market is an important milestone for the Company and we are thrilled by the opportunity to partner with TESTDNA to establish ColoAlert’s commercial footprint in this territory,” commented Darin Leigh, Chief Commercial Officer of Mainz Biomed.
  • Mainz Biomed is providing ColoAlert to TESTDNA under the standard terms of the Company’s partnership agreements.
  • In the coming weeks, Mainz Biomed will work with TESTDNA to prepare and launch co-marketing activities to ensure successful commercialization in the Polish market.