IFU

Mauro Usability Science Announces 3 New Advanced Human Factors Research and Usability Testing Methodologies for Medical Products

Retrieved on: 
Wednesday, October 19, 2022

NEW YORK, Oct. 19, 2022 /PRNewswire/ -- Founded in 1975, MUS is a leading provider of human factors research and usability testing services for medical products requiring FDA submission.

Key Points: 
  • NEW YORK, Oct. 19, 2022 /PRNewswire/ -- Founded in 1975, MUS is a leading provider of human factors research and usability testing services for medical products requiring FDA submission.
  • This produces a roadmap for medical products that have emotional resonance and robust human factors benefits for designated medical professionals.
  • More
    Method 3 AGILE Medical Product FDA Summative Human Factors / Usability Testing for Risk and Cost Reduction.
  • Our experience reveals that a surprising number of medical products arrive at summative testing with serious usability problems.

International Infection Prevention Week Serves to Highlight New Reprocessing Standards and Available Resources for Infection Preventionists

Retrieved on: 
Tuesday, October 18, 2022

CENTER VALLEY, Pa., Oct. 18, 2022 /PRNewswire/ -- Olympus Corp. of the Americas reminds infection prevention professionals of the importance of elevating the standard of patient care and safety during International Infection Prevention Week, which marks the Association for Professionals in Infection Control and Epidemiology's (APIC) 50th anniversary.

Key Points: 
  • Olympus partners with APIC and other professional organizations in providing education to infection prevention professionals and helping support reprocessing standards.
  • Olympus infection prevention tools and resources align with these standards, and our suite of cleaning, disinfection and sterilization products equip infection prevention professionals to comply with recommended guidelines.
  • With infection prevention as an issue at the fore this year, the World Health Organization promoted infection prevention measures with publication earlier this year of its "Global Report on Infection Prevention and Control."
  • 1World Health Organization, "Global Report on Infection Prevention and Control, executive summary," May 2022
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Is it COVID-19 or Flu? A Dual Antigen Test Developed by Irish Company MyBio Now Available to the Public

Retrieved on: 
Wednesday, September 28, 2022

Kilkenny based life sciences company MyBio has today announced the launch of their new combo Covid-19 and Influenza antigen test.

Key Points: 
  • Kilkenny based life sciences company MyBio has today announced the launch of their new combo Covid-19 and Influenza antigen test.
  • The company, who were the first to bring COVID-19 antigen tests to Ireland, developed the dual test to address the challenge of quickly determining whether fever, headache, muscle pain, cough, and fatigue are the result of COVID-19 or flu.
  • The test will also help those with one of these symptoms decide whether they should go to work or not.
  • The combo COVID-19 and flu test is available for 5 at mybio.ie significant discounts for care homes, schools and universities.

Incredible One Enterprises, LLC Announces 'Move to Millions' Live Event for Business Owners

Retrieved on: 
Monday, September 19, 2022

Newark, Delaware--(Newsfile Corp. - September 19, 2022) - Incredible One Enterprises, a business transformation company, announces its game-changing Move to Millions live event for high-achieving service-based entrepreneurs and visionaries.

Key Points: 
  • Newark, Delaware--(Newsfile Corp. - September 19, 2022) - Incredible One Enterprises, a business transformation company, announces its game-changing Move to Millions live event for high-achieving service-based entrepreneurs and visionaries.
  • Over the course of 3 full days, business owners and entrepreneurs will be provided with the proven trajectory of a million-dollar company.
  • The entire experience is specifically designed to help business owners pave the path to living a life of wealth and legacy.
  • Incredible One Enterprises, LLC is an award-winning, Inc5000 recognized business growth consulting firm founded by CEO Dr. Darnyelle Harmon in 2007.

DBV Technologies Announces Initiation of Phase 3 Study (VITESSE) Using the Modified Viaskin Peanut Patch in Peanut -Allergic Children Ages 4 to 7 Years

Retrieved on: 
Wednesday, September 7, 2022

Following productive discussions, the FDA granted DBV a Type C meeting in May 2022 to align on the VITESSE study.

Key Points: 
  • Following productive discussions, the FDA granted DBV a Type C meeting in May 2022 to align on the VITESSE study.
  • We are pleased to have initiated the VITESSE study, said Daniel Tass, Chief Executive Officer of DBV Technologies.
  • While adhesion of the modified Viaskin Peanut patch will be assessed in VITESSE, there is no patch detachment endpoint included in the study parameters.
  • This pivotal Phase 3 clinical study, called VITESSE, features the modified Viaskin Peanut (mVP) patch.

FDA Approves Abbott's New Spinal Cord Stimulation Device; Provides Tailored Relief to Multiple Pain Areas and Adds More Treatment Options for Evolving Pain Conditions

Retrieved on: 
Tuesday, August 23, 2022

BurstDR therapy is Abbott's exclusive stimulation technology that delivers pulses or bursts of mild electrical energy to alter pain signals as they travel from the spinal cord to the brain.

Key Points: 
  • BurstDR therapy is Abbott's exclusive stimulation technology that delivers pulses or bursts of mild electrical energy to alter pain signals as they travel from the spinal cord to the brain.
  • Spinal Cord Stimulation for Chronic Pain Syndromes: A Review of Considerations in Practice Management.
  • Pain.
  • Utilizing intraoperative neuromonitoring to program multiple areas of Burst spinal cord stimulation for treatment of chronic pain.

AeroClean Technologies Proven to Eliminate the Active Omicron Variant of SARS-CoV-2 in the Air

Retrieved on: 
Wednesday, August 10, 2022

PALM BEACH GARDENS, Fla., Aug. 10, 2022 (GLOBE NEWSWIRE) -- AeroClean Technologies (“AeroClean” or the “Company”) (Nasdaq: AERC), a leading air hygiene technology company today announced that independent laboratory testing has proven the company’s Pūrgo™ air purifier is effective at reducing the viral concentration of the Omicron variant of SARS-CoV-2, the virus that causes COVID-19, which the CDC identifies as the current dominant variant in the United States.

Key Points: 
  • We are very proud that our technology continues to prove its efficacy against harmful pathogens - including the highly contagious Omicron variant of SARS-CoV-2, said AeroClean CEO, Jason DiBona.
  • These test results offer real-world value when you consider that our Prgo units can reduce 90% of the active airborne SARS-CoV-2 within indoor spaces in minutes.
  • AeroCleans efficacy test report on the Omicron Variant of SARS-CoV-2 can be available on request by sending an email to [email protected] .
  • AeroClean is a pathogen elimination technology company on a mission to keep work, play and life going by improving indoor air quality.

An Innovative Surfactant Delivery Solution to Treat NRDS

Retrieved on: 
Tuesday, May 10, 2022

BLEScathTM is intended for the administration of bovine lipid extract surfactant suspension (BLES) using minimally invasive surfactant therapy (MIST) / less invasive surfactant administration (LISA) technique for rescue treatment of infants with NRDS.

Key Points: 
  • BLEScathTM is intended for the administration of bovine lipid extract surfactant suspension (BLES) using minimally invasive surfactant therapy (MIST) / less invasive surfactant administration (LISA) technique for rescue treatment of infants with NRDS.
  • With the combination of BLEScathTM and use with BLES, we are equipped to provide a broader range of product offerings and resources to address and lead innovation that compliments global surfactant delivery treatment to neonates experiencing NRDS.
  • BLES Biochemicals Inc. is an established global player in providing innovative solutions for treating NRDS.
  • We want to live in a world where every neonate has access to life-saving pulmonary surfactant and associated delivery devices.

Kallik Selects TEKLYNX as Strategic Integration Partner for Label and Artwork Management Solution

Retrieved on: 
Tuesday, February 15, 2022

MILWAUKEE, Feb. 15, 2022 /PRNewswire-PRWeb/ -- TEKLYNX International , known for helping companies barcode better with their label design and print automation software, today announces being selected as strategic integration partner of choice by Kallik to help power their Veraciti enterprise labeling and artwork management solution.

Key Points: 
  • MILWAUKEE, Feb. 15, 2022 /PRNewswire-PRWeb/ -- TEKLYNX International , known for helping companies barcode better with their label design and print automation software, today announces being selected as strategic integration partner of choice by Kallik to help power their Veraciti enterprise labeling and artwork management solution.
  • "Together, Kallik and TEKLYNX have over 50 years of experience in labeling software, artwork management, and professional services," says Thierry Mauger, TEKLYNX International President.
  • Kallik's labeling and artwork management solution is purpose-built for highly regulated industries looking for an effortless way to manage all labeling and artwork, maintain compliance, and increase speed to market.
  • Kallik, the enterprise labeling company, provides regulated industries with a definitive, end-to-end artwork management and label management platform they can trust.

Real-World Evidence Study Demonstrates Intersect ENT’s PROPEL® Sinus Implant Reduces Healthcare Resource Utilization

Retrieved on: 
Tuesday, January 25, 2022

Study results demonstrate that patients receiving PROPEL sinus implants following sinus surgery had lower healthcare resource utilization (HCRU) over a postoperative period of 18 months compared with patients who did not receive an implant.

Key Points: 
  • Study results demonstrate that patients receiving PROPEL sinus implants following sinus surgery had lower healthcare resource utilization (HCRU) over a postoperative period of 18 months compared with patients who did not receive an implant.
  • Due to this potential difference, the results may underestimate the full impact of PROPEL on healthcare resource utilization and revision surgery.
  • For more information about PROPEL (mometasone furoate) sinus implants, SINUVA (mometasone furoate) sinus implant, and VenSure and Cube, please visit www.PROPELOPENS.com , www.SINUVA.com and www.VenSureandCube.com .
  • The PROPEL sinus implants are intended to maintain patency and locally deliver steroid to the sinus mucosa in patients 18 years of age following sinus surgery: PROPEL for the ethmoid sinus, PROPEL Mini for the ethmoid sinus/frontal sinus opening, and PROPEL Contour for the frontal/maxillary sinus ostia.