CE

Implantica submits U.S. FDA Premarket Approval (PMA) application for RefluxStop® (first module)

Retrieved on: 
Wednesday, March 27, 2024
Cancer, PPI, CE, PMID, Patient, Internet, PMA, Literature, File, Gastroesophageal reflux disease, FDA, Certification, Pharmaceutical industry

The U.S. FDA has agreed to a modular submission process for the RefluxStop PMA application.

Key Points: 
  • The U.S. FDA has agreed to a modular submission process for the RefluxStop PMA application.
  • This process provides for ongoing review and feedback from the FDA as the modules are submitted.
  • The second and third (final) modules are anticipated to be submitted to the FDA in three-month intervals later this year.
  • Dr. Peter Forsell, CEO of Implantica, says, "This FDA filing is a key fundamental milestone for RefluxStop®3 and puts us in motion for the U.S. launch preparation ahead of the pending FDA approval.

NCC Launches Second Chance Free Promotion and Updated Bulk Purchase Program!

Retrieved on: 
Wednesday, March 27, 2024
Health, Certification, CE, National Certification Corporation, MUST, NCC, Nursing

CHICAGO, March 27, 2024 /PRNewswire-PRWeb/ -- The Second Chance Free* Examination Promotion gives participants two chances to pass ALL NCC certification examinations. Participants MUST register between April 15 and July 15, 2024, to take advantage of this limited time promotion and earn their nationally accredited and Magnet™ approved NCC certification. If the first attempt fails… they can retake the same exam for free! *Learn more about Second Chance Free at NCCwebsite.org.

Key Points: 
  • The National Certification Corporation (NCC) is pleased to announce their Spring 2024 SECOND CHANCE FREE* certification examination promotion along with the simultaneous launch of their updated Bulk Certification Examination Purchase Program.
  • CHICAGO, March 27, 2024 /PRNewswire-PRWeb/ -- The Second Chance Free* Examination Promotion gives participants two chances to pass ALL NCC certification examinations.
  • Participants MUST register between April 15 and July 15, 2024, to take advantage of this limited time promotion and earn their nationally accredited and Magnet™ approved NCC certification.
  • NCC's Bulk Certification Examination Purchase Program allows institutions or individuals to purchase multiple exam vouchers in any mix of Nursing and/or Multidisciplinary certifications with one convenient transaction – no contract required!

New Report from Modern Campus Reveals: 61% of Higher Education Leaders Believe Continuing Education Units are Undervalued Compared to Traditional Departments

Retrieved on: 
Tuesday, March 26, 2024
Online, PCO, Learning, CE, Partnership, CAUCE, Education, UPCEA, University, Student, UNESCO, Continuing education, Division

TORONTO, March 26, 2024 /PRNewswire-PRWeb/ -- In a landscape defined by innovation and academic excellence, Professional, Continuing, and Online education units (PCO) play a pivotal yet underappreciated role in higher education. Despite their role in shaping the modern learner's journey, a staggering 61% of higher education leaders feel their PCO units are not accorded the same recognition as other academic entities within their institutions.

Key Points: 
  • Despite their role in shaping the modern learner's journey, a staggering 61% of higher education leaders feel their PCO units are not accorded the same recognition as other academic entities within their institutions.
  • This insight comes from the annual 2024 State of Continuing Education report , published by higher education learner-to-earner platform leader Modern Campus , in partnership with the Canadian Association for University Continuing Education (CAUCE), The EvoLLLution , and UPCEA, the online and professional education association.
  • The study explores PCO unit program offerings, institutional support and capabilities, perceptions of the competitive landscape, and continuing education (CE) collaboration and integration within the larger institution.
  • "Online and professional continuing education continues to experience increasing support from institutional leadership.

New Varistat Benchtop Ionizer for Hands-Free Static Elimination

Retrieved on: 
Tuesday, March 26, 2024
UL, Printing, Multimedia, LED, CE, Atmosphere

CINCINNATI, March 26, 2024 /PRNewswire-PRWeb/ -- EXAIR's Varistat Benchtop Ionizer is the latest solution for neutralizing static on charged surfaces in industrial settings. Utilizing ionizing technology, the Varistat provides a hands-free solution that requires no compressed air and provides a constant stream of particulate-free and static eliminating air. Easily mounted on benchtops or machines, this static eliminator is manually adjustable and perfect for processes needing comprehensive coverage, like part assembly, web cleaning, printing and more.

Key Points: 
  • CINCINNATI, March 26, 2024 /PRNewswire-PRWeb/ -- EXAIR's Varistat Benchtop Ionizer is the latest solution for neutralizing static on charged surfaces in industrial settings.
  • Utilizing ionizing technology, the Varistat provides a hands-free solution that requires no compressed air and provides a constant stream of particulate-free and static eliminating air.
  • The Varistat is the first fan-driven static eliminator to be offered by EXAIR, expanding available solutions while maintaining top-of-the-line performance.
  • Once plugged in, the Varistat provides rapid static decay capable of reducing 1000V to 100V in .8 seconds.

Inside information: Bioretec's RemeOs™ biodegradable magnesium alloy composition has been allowed a patent by the U.S. Patent office

Retrieved on: 
Thursday, March 21, 2024
PCT, CE, Patient, Trauma, Health care, IPR, Patent, USD, EET

TAMPERE, Finland, March 21, 2024 /PRNewswire/ -- Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has been allowed a patent by the U.S. patent office for its RemeOs™ magnesium alloy composition. The U.S. patent office will grant and publish the patent after the Company's confirmation.

Key Points: 
  • Bioretec Ltd Inside information 21 March 2024 at 7:00 p.m. EET
    TAMPERE, Finland, March 21, 2024 /PRNewswire/ -- Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has been allowed a patent by the U.S. patent office for its RemeOs™ magnesium alloy composition.
  • The U.S. patent office will grant and publish the patent after the Company's confirmation.
  • Allowed patent concerns RemeOs™ magnesium-calcium-zinc alloy composition for orthopedic implants[1].
  • The patent also includes the usage of the RemeOs™ magnesium alloy in the manufacturing of orthopedic implants or a part of such implants for all patient populations.

Inside information: Bioretec's RemeOs™ biodegradable magnesium alloy composition has been allowed a patent by the U.S. Patent office

Retrieved on: 
Thursday, March 21, 2024
PCT, CE, Patient, Trauma, Health care, IPR, Patent, USD, EET

TAMPERE, Finland, March 21, 2024 /PRNewswire/ -- Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has been allowed a patent by the U.S. patent office for its RemeOs™ magnesium alloy composition. The U.S. patent office will grant and publish the patent after the Company's confirmation.

Key Points: 
  • Bioretec Ltd Inside information 21 March 2024 at 7:00 p.m. EET
    TAMPERE, Finland, March 21, 2024 /PRNewswire/ -- Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has been allowed a patent by the U.S. patent office for its RemeOs™ magnesium alloy composition.
  • The U.S. patent office will grant and publish the patent after the Company's confirmation.
  • Allowed patent concerns RemeOs™ magnesium-calcium-zinc alloy composition for orthopedic implants[1].
  • The patent also includes the usage of the RemeOs™ magnesium alloy in the manufacturing of orthopedic implants or a part of such implants for all patient populations.

ExtriCARE USA Introduces the ExtriCARE 1000 NPWT System

Retrieved on: 
Tuesday, March 19, 2024
Philosophy, Patient, Certification, FDA, Exudate, CE, NPWT, Mobility

NORRISTOWN, Pa., March 19, 2024 /PRNewswire/ -- ExtriCARE USA, a leader in advanced wound care solutions, proudly announces the launch of the ExtriCARE 1000 Negative Pressure Wound Therapy (NPWT) System.

Key Points: 
  • NORRISTOWN, Pa., March 19, 2024 /PRNewswire/ -- ExtriCARE USA, a leader in advanced wound care solutions, proudly announces the launch of the ExtriCARE 1000 Negative Pressure Wound Therapy (NPWT) System.
  • The ExtriCARE 1000 sets a new standard in wound care therapy with its tailored approach.
  • Designed for patient comfort and mobility, the ExtriCARE 1000 is compact and lightweight, weighing just 0.5 lbs., facilitating ease of use in various care settings.
  • The ExtriCARE 1000 offers versatility and utilizes ExtriCARE's hybrid NPWT (hNPWT) philosophy.

QDOSE® Platform Partnership for Personalised Dosimetry in Radiopharmaceutical Therapy

Retrieved on: 
Monday, March 18, 2024
Radiation, CE, ASX, European, TLX, FDA, Nuclear medicine, Medical imaging

QDOSE® is a validated, versatile software platform that enables reliable estimation of patient-specific dosimetry for both therapeutic and diagnostic radiopharmaceuticals.

Key Points: 
  • QDOSE® is a validated, versatile software platform that enables reliable estimation of patient-specific dosimetry for both therapeutic and diagnostic radiopharmaceuticals.
  • Telix intends to integrate the QDOSE® platform into its therapeutic radiopharmaceutical programs and clinical collaborations to enable the development of personalised treatment regimens.
  • Personalised radiopharmaceutical therapy administration based on individual patient dosimetry has the potential to improve clinical outcomes by optimising treatment response while reducing effects on normal healthy organs and optimising the use of isotope supply chains.
  • Rapid, reliable and personalised dosimetry is becoming an increasingly important future direction of cancer care and regulatory authorities now expect to see dosimetry analysis.

Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOs™ Spinal Interbody Cage

Retrieved on: 
Thursday, March 14, 2024
CE, Acceleration, Patient, Trauma, Health care, Breakthrough, Quality of life, USD, FDA, Hospital, Pharmaceutical industry

TAMPERE, Finland, March 14, 2024 /PRNewswire/ -- Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has today been granted Breakthrough Device Designation for its RemeOs™ Spinal Interbody Cage implant from the US Food and Drug Administration, confirming that the product represents a breakthrough technology in spinal surgery.

Key Points: 
  • TAMPERE, Finland, March 14, 2024 /PRNewswire/ -- Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has today been granted Breakthrough Device Designation for its RemeOs™ Spinal Interbody Cage implant from the US Food and Drug Administration, confirming that the product represents a breakthrough technology in spinal surgery.
  • RemeOs Spinal Interbody Cages are intended to be used to restore intervertebral height and facilitate intervertebral body fusion in the cervical spine.
  • Bioretec's biodegradable RemeOs™ Spinal Interbody Cage met the strict criteria set for entering the FDA's Breakthrough Device Designation program.
  • Under the Breakthrough Devices Program, the FDA will enable an ongoing and prioritized interactive discussion between Bioretec and the authorities regarding the commercial access of RemeOs™ Spinal Interbody Cage implant in the U.S. market.

Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOs™ Spinal Interbody Cage

Retrieved on: 
Thursday, March 14, 2024
CE, Acceleration, Patient, Trauma, Health care, Breakthrough, Quality of life, USD, FDA, Hospital, Pharmaceutical industry

TAMPERE, Finland, March 14, 2024 /PRNewswire/ -- Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has today been granted Breakthrough Device Designation for its RemeOs™ Spinal Interbody Cage implant from the US Food and Drug Administration, confirming that the product represents a breakthrough technology in spinal surgery.

Key Points: 
  • TAMPERE, Finland, March 14, 2024 /PRNewswire/ -- Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has today been granted Breakthrough Device Designation for its RemeOs™ Spinal Interbody Cage implant from the US Food and Drug Administration, confirming that the product represents a breakthrough technology in spinal surgery.
  • RemeOs Spinal Interbody Cages are intended to be used to restore intervertebral height and facilitate intervertebral body fusion in the cervical spine.
  • Bioretec's biodegradable RemeOs™ Spinal Interbody Cage met the strict criteria set for entering the FDA's Breakthrough Device Designation program.
  • Under the Breakthrough Devices Program, the FDA will enable an ongoing and prioritized interactive discussion between Bioretec and the authorities regarding the commercial access of RemeOs™ Spinal Interbody Cage implant in the U.S. market.