Medical device regulation

EQS-News: PRECISIS GmbH: EASEE – ­­­World's first minimally invasive brain pacemaker for the treatment of epilepsy receives CE-certification and is available immediately

Retrieved on: 
Friday, September 23, 2022

Heidelberg, 23.09.2022 after seven years of development work, Precisis GmbH, headquartered in Heidelberg, has received the CE certification for its minimally invasive brain pacemaker EASEE.

Key Points: 
  • Heidelberg, 23.09.2022 after seven years of development work, Precisis GmbH, headquartered in Heidelberg, has received the CE certification for its minimally invasive brain pacemaker EASEE.
  • These drug-refractory patients wait an average of 22 years before they are offered further technical or surgical treatment options.
  • With this new, risk-minimized EASEE method, the treatment spectrum is expanded in the early phases of the disease."
  • EASEE is an acronym for Epicranial Application of Stimulation Electrodes for Epilepsy.

CIRCA Scientific's Quality Management System Awarded EU-MDR Certification

Retrieved on: 
Wednesday, September 7, 2022

ENGLEWOOD, Colo., Sept. 7, 2022 /PRNewswire/ -- CIRCA Scientific announced that the company has successfully met the requirements for certification of its Quality Management System (QMS) under the new European Union Medical Device Regulation (MDR) as of August 24th, 2022. To earn this certificate, BSI Group, CIRCA Scientific's notified body, completed a comprehensive conformity assessment and confirmed compliance of its QMS with the new, strengthened safety and performance requirements of the MDR. MDR certification allows CIRCA Scientific not only to continue to distribute its existing products in European markets but opens the door to proceed with its plans for new product developments and launches in the EU.

Key Points: 
  • ENGLEWOOD, Colo., Sept. 7, 2022 /PRNewswire/ --CIRCA Scientific announced that the company has successfully met the requirements for certification of its Quality Management System (QMS) under the new European Union Medical Device Regulation (MDR) as of August 24th, 2022.
  • To earn this certificate, BSI Group, CIRCA Scientific's notified body, completed a comprehensive conformity assessment and confirmed compliance of its QMS with the new, strengthened safety and performance requirements of the MDR.
  • MDR certification allows CIRCA Scientific not only to continue to distribute its existing products in European markets but opens the door to proceed with its plans for new product developments and launches in the EU.
  • I'd like to acknowledge the tireless work of our Quality Assurance team who managed all the activities required to establish compliance with the new regulation.

$1.87 Billion Lithotripsy Devices Market Insights, Competitive Landscape and Market Forecasts, 2027 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, August 10, 2022

The "Lithotripsy Devices Market Insights, Competitive Landscape and Market Forecast - 2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Lithotripsy Devices Market Insights, Competitive Landscape and Market Forecast - 2027" report has been added to ResearchAndMarkets.com's offering.
  • Global Lithotripsy Devices Market was valued at USD 1.44 billion in 2021, growing at a CAGR of 4.35% during the forecast period from 2022 to 2027, to reach USD 1.87 billion by 2027.
  • Such technological advancement in the field of Lithotripsy Devices is likely to boost the Global Lithotripsy Devices Market during the forecast period.
  • Which are the regions and countries where companies should have concentrated on opportunities for Lithotripsy Devices market growth in the coming future?

Virtual Training Course: An Introduction to the Medical Device Regulation (November 8-10, 2022) - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 28, 2022

The "An Introduction to the Medical Device Regulation Training Course" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "An Introduction to the Medical Device Regulation Training Course" conference has been added to ResearchAndMarkets.com's offering.
  • This seminar provides an invaluable overview of the European Medical Device Regulation (MDR).
  • This event will be of particular interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector.
  • What is a medical device?

Flat Medical Enters the Vascular Access Medtech Domain with its Newly Acquired MDR Certification and New Medical Advisor

Retrieved on: 
Tuesday, July 12, 2022

"This is a super exciting achievement for our team with significantly meaningful value," said Shao-Wei Tseng, the Chief Regulatory Officer of Flat Medical.

Key Points: 
  • "This is a super exciting achievement for our team with significantly meaningful value," said Shao-Wei Tseng, the Chief Regulatory Officer of Flat Medical.
  • "As the first Taiwanese Medtech company awarded MDR certification from the BSI, we feel honored to be certified to supply our innovative solution to improve the safety and quality of central venous catheterization procedures."
  • Flat Medical is now organizing a product launch with its local partners in the U.S. and Europe.
  • Flat Medical is a MedTech company that focuses on safety solutions for clinical procedures.

Supplier Management with the new Medical Device Regulation EU MDR 745/2017 - Webinar - ResearchAndMarkets.com

Retrieved on: 
Friday, July 1, 2022

The "Supplier Management with the new Medical Device Regulation EU MDR 745/2017" webinar has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Supplier Management with the new Medical Device Regulation EU MDR 745/2017" webinar has been added to ResearchAndMarkets.com's offering.
  • The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements.
  • Both, the ISO standard and the MDR requires for outsourced processes additional activities and be careful with outsourced processes.
  • The webinar will describe the following vital topics:
    Overview about the changes of the EU MDR 745/2017 regarding supplier and outsourced activities.

Allmed becomes the first fully MDR compliant haemodialysis product producer in Europe, the Middle East and Africa (EMEA) region

Retrieved on: 
Wednesday, June 15, 2022

With the certification, Allmed has become the first haemodialysis products producer in the EMEA region to accomplish and certify full MDR compliance on its medical devices.

Key Points: 
  • With the certification, Allmed has become the first haemodialysis products producer in the EMEA region to accomplish and certify full MDR compliance on its medical devices.
  • Becoming the first fully compliant haemodialysis product producer in the EMEA region is a testament to our commitment to delivering high quality, safe solutions to haemodialysis patients, and I am proud of the many months of hard work and commitment by Allmeds Total Quality Management team.
  • This achievement is a testament to their commitment to ensuring innovation remains at the forefront of their product development.
  • Allmed Group is a global producer of end-to-end haemodialysis product solutions.

Mentice AB intends to acquire all assets related to the software solution Ankyras from the Spanish corporation Galgo Medical S.L.

Retrieved on: 
Thursday, June 9, 2022

The Acquisition is characterized as a technology acquisition as this solution is in an early phase of its commercialization.

Key Points: 
  • The Acquisition is characterized as a technology acquisition as this solution is in an early phase of its commercialization.
  • However, the solution has been developed for a long time by Galgo and the software Ankyras is patent protected and CE-marked product (Medical Device Regulation MDR) with technology published by Galgo since 2013.
  • Ankyras is an advanced cloud-based analysis solution that allows a physician to plan treatment for a specific patient.
  • This disclosure contains information that Mentice AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014).

Mentice AB intends to acquire all assets related to the software solution Ankyras from the Spanish corporation Galgo Medical S.L.

Retrieved on: 
Thursday, June 9, 2022

The Acquisition is characterized as a technology acquisition as this solution is in an early phase of its commercialization.

Key Points: 
  • The Acquisition is characterized as a technology acquisition as this solution is in an early phase of its commercialization.
  • However, the solution has been developed for a long time by Galgo and the software Ankyras is patent protected and CE-marked product (Medical Device Regulation MDR) with technology published by Galgo since 2013.
  • Ankyras is an advanced cloud-based analysis solution that allows a physician to plan treatment for a specific patient.
  • This disclosure contains information that Mentice AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014).

Implantica publishes Interim Report Q1, January - March 2022

Retrieved on: 
Wednesday, May 11, 2022

STOCKHOLM, May 11, 2022 /PRNewswire/ -- 

Key Points: 
  • Implantica continued during this quarter to substantially strengthen its organisation on a broad front.
  • Our regulatory and clinical teams have been diligently preparing the extensive RefluxStop PMA application for FDA approval in US.
  • We also continued to expand our presence in our US subsidiary, Implantica Inc.
    Cash and short-term investments as at the end of the period amounted to MEUR 125.7.
  • Implantica will hold a telephone conference on May 11 at 15:00 CET.