Notified body

EQS-News: After a mixed 2023 financial year, aap makes a strong start to the 2024 financial year

Retrieved on: 
Thursday, February 15, 2024

After a mixed 2023 financial year, aap makes a strong start to the 2024 financial year

Key Points: 
  • After a mixed 2023 financial year, aap makes a strong start to the 2024 financial year
    The issuer is solely responsible for the content of this announcement.
  • In the past financial year, aap Implantate AG ("aap" or "Company") was able to significantly accelerate patient recruitment with the realignment of the world's first clinical human study for its innovative antibacterial implant technology.
  • Building on these promising developments, aap will continue its efforts to attract significant third-party funding for the industrial expansion of the technology in the 2024 financial year.
  • After a mixed 2023 financial year in the LOQTEQ® trauma division, aap was able to make a positive start to the new 2024 financial year.

MCRA Announces European Expansion

Retrieved on: 
Wednesday, January 10, 2024

WASHINGTON, Jan. 10, 2024 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its expansion in Europe with three new offices in London, United Kingdom, Winterthur, Switzerland, and Eschborn, Germany.

Key Points: 
  • New Services and Offices in United Kingdom, Switzerland, and Germany
    In addition to these new offices, MCRA has also expanded its service offerings in Europe to accommodate growing client needs.
  • MCRA Europe now offers GDPR compliance, representative services for clinical studies and Unique Device Identifier (UDI) services in addition to its core services of Regulatory Affairs, Clinical Research and Quality Assurance.
  • Abigail Allen, Vice President, Clinical Affairs states, "Our European presence further supports our global CRO by facilitating access to European patients and utilizing our country specific knowledge and expertise to streamline approvals and trial management.
  • Anthony Viscogliosi, CEO of MCRA, states "Europe is the second largest medical device market in the world.

iRhythm Technologies Receives European Union’s CE Marking Under Medical Device Regulation (EU MDR) for its Zio® monitor and ZEUS System

Retrieved on: 
Wednesday, January 3, 2024

The Zio monitor ECG System secured its CE mark based on compliance to EU MDR standards of performance, quality, safety, and efficacy, along with the body of clinical evidence supporting Zio in detecting potential cardiac arrhythmias.

Key Points: 
  • The Zio monitor ECG System secured its CE mark based on compliance to EU MDR standards of performance, quality, safety, and efficacy, along with the body of clinical evidence supporting Zio in detecting potential cardiac arrhythmias.
  • The new Zio monitor is thinner, lighter, and smaller compared to Zio XT to provide a more inconspicuous wear experience.2-4.
  • Early clinical and patient experience in the United States has shown that Zio monitor has even better wear times and analyzable ECG2.
  • Furthermore, the certification incorporates CE mark for the ZEUS (Zio ECG Utilization Software) System, iRhythm’s advanced deep-learned AI algorithm which supports the capture and analysis of ECG data recorded by Zio monitor.

Nanox Announces Third Quarter of 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, November 28, 2023

NEVE ILAN, Israel, Nov. 28, 2023 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD (NASDAQ: NNOX) (“Nanox” or the “Company”), an innovative medical imaging technology company, today announced results for the third quarter ended September 30, 2023 and provided a business update.

Key Points: 
  • Generated $2.5 million in revenue in the third quarter of 2023, compared to $2.4 million in the third quarter of 2022.
  • The Company reported revenue of $2.5 million in the reported period, compared to $2.4 million in the comparable period.
  • During the third quarter of 2023, Nanox AI continued to complete pilot programs with marketplaces, marketplace costumers and health organizations in anticipation of full deployment of its products.
  • A reconciliation between GAAP and non-GAAP financial measures for the three- and nine-month periods ended September 30, 2023, and 2022 is provided in the financial results that are part of this press release.

Hexadrone Starts C5 and C6 Drone Type Examination After Successful GAP Analysis of The TUNDRA 2’ Specification by Notified Body

Retrieved on: 
Monday, December 11, 2023

This compliance will ensure that the TUNDRA 2 users will be able to fly in European airspace legally, in accordance with categories C5 and C6, from 2024.

Key Points: 
  • This compliance will ensure that the TUNDRA 2 users will be able to fly in European airspace legally, in accordance with categories C5 and C6, from 2024.
  • Marcel Visser, CEO of NavCert GmbH, stated, “Congratulations to Hexadrone on being first confirming both multicopter C5 and C6 Drone specification compliancy to Delegated Regulation (EU) 2019/945.
  • We are honored to be the Notified Body (NB 2603) selected by Hexadrone to perform Type Examinations for both version of the Tundra 2.
  • Starting 2024, Hexadrone is accelerating it’s worldwide expansion by selecting and recruiting Specialised resellers over the Globe.

ProPharma Launches an Integrated MedTech Organization Providing End-to-End Solutions for Innovators

Retrieved on: 
Thursday, November 16, 2023

RALEIGH, N.C., Nov. 16, 2023 /PRNewswire-PRWeb/ -- ProPharma Group, the world's largest Research Consulting Organization (RCO) and the leading global provider of regulatory, clinical and quality compliance services for the life sciences industry, has today launched a new Integrated Global MedTech Practice to provide end-to-end solutions for medical technology companies.

Key Points: 
  • ProPharma Group has today launched a new Integrated Global MedTech Practice to provide end-to-end solutions for medical technology companies.
  • "ProPharma's new MedTech practice has extensive experience and offers scalable solutions tailored to client needs, regardless of size or geography" –Dr.
  • The MedTech organization includes Regulatory Strategy, Clinical Strategy and Development, Quality Management and Compliance, Market Access and Reimbursement, and Post Market Surveillance.
  • For more information about ProPharma Group's Global MedTech Practice and its suite of services, please visit https://www.propharmagroup.com/ .

Neoss® Group receives EU Medical Device Regulation (MDR) certifications for implants and abutments

Retrieved on: 
Thursday, October 12, 2023

ZÜRICH, Oct. 12, 2023 /PRNewswire/ -- Neoss Group, a leading innovator in dental implant solutions, is proud to announce that it has received EU Medical Device Regulation (MDR) certification by its Notified Body, the BSI Group, the Netherlands B.V. for its implants and abutments.

Key Points: 
  • ZÜRICH, Oct. 12, 2023 /PRNewswire/ -- Neoss Group, a leading innovator in dental implant solutions, is proud to announce that it has received EU Medical Device Regulation (MDR) certification by its Notified Body, the BSI Group, the Netherlands B.V. for its implants and abutments.
  • This signifies that Neoss Group's Quality Management System and its implants and abutments meet the requirements of the new MDR implemented by the European Union.
  • The new EU Medical Devices Regulation 2017/745 (MDR) replaces the former European Medical Device Directive 93/42/EEC (MDD), and brings EU legislation into line with technical advances, changes in medical science and progress in law-making.
  • The new MDR regulation contains a series of important improvements including establishing a comprehensive and accessible EU database on medical devices with a device traceability system based on a unique device identification.

Neoss® Group receives EU Medical Device Regulation (MDR) certifications for implants and abutments

Retrieved on: 
Thursday, October 12, 2023

ZÜRICH, Oct. 12, 2023 /PRNewswire/ -- Neoss Group, a leading innovator in dental implant solutions, is proud to announce that it has received EU Medical Device Regulation (MDR) certification by its Notified Body, the BSI Group, the Netherlands B.V. for its implants and abutments.

Key Points: 
  • ZÜRICH, Oct. 12, 2023 /PRNewswire/ -- Neoss Group, a leading innovator in dental implant solutions, is proud to announce that it has received EU Medical Device Regulation (MDR) certification by its Notified Body, the BSI Group, the Netherlands B.V. for its implants and abutments.
  • This signifies that Neoss Group's Quality Management System and its implants and abutments meet the requirements of the new MDR implemented by the European Union.
  • The new EU Medical Devices Regulation 2017/745 (MDR) replaces the former European Medical Device Directive 93/42/EEC (MDD), and brings EU legislation into line with technical advances, changes in medical science and progress in law-making.
  • The new MDR regulation contains a series of important improvements including establishing a comprehensive and accessible EU database on medical devices with a device traceability system based on a unique device identification.

AgEagle’s eBee Drones Receive EASA’s C6 Certificate for BVLOS Flights in the European Union

Retrieved on: 
Wednesday, October 4, 2023

WICHITA, Kan., Oct. 04, 2023 (GLOBE NEWSWIRE) -- AgEagle Aerial Systems Inc. (NYSE American: UAVS) (“AgEagle” or the “Company”), an industry-leading provider of full stack flight hardware, sensors and software for commercial and government use, today announced that the eBee X™, eBee TAC™ Public Safety, eBee™ Ag and eBee™ Geo drones (“eBee X Series”) have been designated with the C6 class identification label in accordance with the European Union (“EU”) regulations.

Key Points: 
  • With this new certification, the eBee X Series become the only professional drones in the market with both C6 and C2 markings, providing distinct advantages to operators throughout Europe.
  • Barrett Mooney , Chairman and CEO of AgEagle, noted, “The inclusion of the C6 marking alongside our C2-labeled eBee drones will significantly enhance the market advantages for our European customers.
  • Marcel Visser, Managing Director of NavCert GmbH, stated, “Congratulations to AgEagle on achieving the C6 marking for the eBee X series drones.
  • We remain dedicated to upholding the requisite standards of quality and safety for drone operations within the European Union."

Implantica receives MDR certification for RefluxStop™

Retrieved on: 
Thursday, September 7, 2023

The latest Notified Body survey published by the European Commission in July 2023 estimated that of 11,418 MDR applications, only 2,951 had successfully achieved MDR certificates.

Key Points: 
  • The latest Notified Body survey published by the European Commission in July 2023 estimated that of 11,418 MDR applications, only 2,951 had successfully achieved MDR certificates.
  • Implantica is in the top quartile of manufacturers achieving MDR certification for its products.
  • "Our EU-MDR certification is a reflection of Implantica's strong commitment to complying with the highest quality and regulatory standards for medical devices.
  • I'd like to thank the team for this significant achievement in our ambition to develop Implantica to a leading medtech company," said Dr. Peter Forsell, CEO of Implantica.