Medical Devices Directive

ISMART Developments first to receive EU-MDR certification for home use LED device

Retrieved on: 
Thursday, April 27, 2023
Medical device, Medical Devices Directive, Light, Acne, Sue, Medical Device Regulation Act, MDSAP, Medical device regulation, Certification, MDR, LED, MDD, European Medical Devices Industry Group, Glycine mollis, TGA, Health, FDA, Health Canada, Safety, EU

BIRMINGHAM, England, April 27, 2023 /PRNewswire/ -- ISMART Developments Ltd (Birmingham, UK) the leader in flexible non-invasive Light emitting Diode (LED) technology announced that they received certification to European Council Medical Device Regulation 2017/745 for their LED acne facemask.

Key Points: 
  • BIRMINGHAM, England, April 27, 2023 /PRNewswire/ -- ISMART Developments Ltd (Birmingham, UK) the leader in flexible non-invasive Light emitting Diode (LED) technology announced that they received certification to European Council Medical Device Regulation 2017/745 for their LED acne facemask.
  • Granted on March 9th, 2023, ISMART Developments Ltd believe they are the first LED device for home use to receive the certification.
  • Sue D'Arcy Chief Executive Officer of ISMART Developments Ltd spoke about the importance of this company milestone.
  • The European Medical Device authorities have been moving from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) in a bid to protect the health and safety of EU citizens.

Cardiac Dimensions Receives Medical Device Regulation (MDR) Certification for Carillon Mitral Contour System

Retrieved on: 
Tuesday, April 25, 2023
Health, Medical Devices, Cardiology, Heart, FMR, Dimension, Carillon, Medical device, University, Heart failure, Civil service commission, Medical Devices Directive, RWTH Aachen University, Certification, MDR, MDD, Patient, Tricuspid valve, European Commission, Safety, EU

Cardiac Dimensions ®, a leader in the development of innovative, minimally invasive treatment modalities to address patients suffering from heart failure with functional mitral regurgitation (FMR), today announced that its Carillon Mitral Contour System® has received certification under Regulation (EU) 2017/745 (“MDR”).

Key Points: 
  • Cardiac Dimensions ®, a leader in the development of innovative, minimally invasive treatment modalities to address patients suffering from heart failure with functional mitral regurgitation (FMR), today announced that its Carillon Mitral Contour System® has received certification under Regulation (EU) 2017/745 (“MDR”).
  • The MDR program is intended to ensure high standards of safety and quality of medical devices that are produced in, or supplied to, member countries of the EU.
  • “The excellent safety profile of the Carillon device coupled with the significant body of high-quality evidence supporting the Carillon® therapy were key factors in achieving MDR certification.
  • MDR certification of the Carillon Mitral Contour System will ensure continued and uninterrupted access to this evidence-based treatment option for heart failure patients with FMR in Europe,” said Prof. Klaus Witte, Chair of Cardiac Device Therapy, University of Aachen.

Celluma Light Therapy Receives EU-MDR Certification

Retrieved on: 
Tuesday, April 4, 2023
Medical device, Bed, Medical Devices Directive, Medical Device Regulation Act, Sale, Medical device regulation, Science, Certification, MDR, LED, MDD, European, Growth, European Medical Devices Industry Group, EU

ANAHEIM, Calif., April 4, 2023 /PRNewswire/ -- BioPhotas, Inc., the manufacturer of the award-winning Celluma SERIES of light therapy devices, announced today that the Company received certification to European Council Medical Device Regulation 2017/745 for low level light therapy devices. Over the course of the last several years, the European Medical Device Authorities have been transitioning from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR). The Company believes it is the first low-level light therapy device manufacturer to be certified to the new MDR standards.

Key Points: 
  • Company expands product offerings in the UK, EU and Switzerland
    ANAHEIM, Calif., April 4, 2023 /PRNewswire/ -- BioPhotas, Inc., the manufacturer of the award-winning Celluma SERIES of light therapy devices, announced today that the Company received certification to European Council Medical Device Regulation 2017/745 for low level light therapy devices.
  • The Company believes it is the first low-level light therapy device manufacturer to be certified to the new MDR standards.
  • Rapidly approaching 100,000 light therapy panels sold around the globe, the Celluma SERIES continues to be recognized as best-in-class LED light therapy, amassing nearly 70 industry awards for best product, most innovative product and best new product in the medical aesthetics and pain management space.
  • Commenting further, Mr. Johnson shared, "when we founded the Company 12 years ago, our fundamental objective was to build a best-in-class medical device company, manufacturing low-level light therapy devices that conformed to the most stringent regulatory requirements.

InspireMD Reports Fourth Quarter and Year-End 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 30, 2023
Medical device, Travel, TCAR, Marketing, Stenosis, Stroke, CE marking, Clinical trial, CAD, Medical device regulation, MRD, TEL, NSPR, Medical Devices Directive, MDR, ...Continued, MDD, Patient, Growth, EPS, IDE, FDA, Global marketing, Food, Stent, Nursing, Cryptocurrency, Pharmaceutical industry, Video game, EU

TEL AVIV, Israel, March 30, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for treatment of carotid artery disease (CAD) and prevention of stroke today announced financial and operating results for the fourth quarter ended December 31, 2022.

Key Points: 
  • Fourth Quarter 2022 and Recent Developments:
    Generated CGuard revenues for the fourth quarter 2022 of $1,026,000, a 20.6% decrease from $1,291,000 for the fourth quarter of 2021.
  • Financial Results for the Fourth Quarter ended December 31, 2022
    For the fourth quarter of 2022, total revenue decreased 25.7%, to $1,026,000, from $1,380,000 during the fourth quarter of 2021.
  • Gross profit for the fourth quarter of 2022 decreased by $96,000, or 32.7%, to $198,000, compared to a gross profit of $294,000 for the fourth quarter of 2021.
  • Total operating expenses for the fourth quarter of 2022, were $5,134,000, an increase of $909,000, or 21.5% compared to $4,225,000 for the fourth quarter of 2021.

3 Day Training Course - Medical Device Studies: Regulatory Requirements and Adverse Event Reporting September 18-21, 2023 - ResearchAndMarkets.com

Retrieved on: 
Thursday, March 16, 2023
Medical Devices, Health, Medical Device Regulation Act, Safety, MDR, Medical Devices Directive, Dietary supplement, Medical device

The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course" conference has been added to ResearchAndMarkets.com's offering.
  • This seminar provides an essential overview of medical device clinical evaluations, clinical investigations and PMCF studies with particular emphasis on the adverse event reporting requirements during these studies.
  • The course will concentrate mostly on the new Medical Device Regulations (MDR) with some references to the existing Medical Device Directives.
  • It also covers the new requirements regarding periodic safety update reports (PSURs) and the summary of safety and clinical performance.

EQS-News: VisionHealth raises 3 million Euro to finance extended COPD and asthma study for market preparation of Kata®, an innovative digital therapeutic for improved inhalation

Retrieved on: 
Monday, February 27, 2023
Clinical trial, Chronic Respiratory Disease, Single-frequency network, Contract research organization, Life, Respiratory failure, DuPont, Business, MDR, Patient, Chronic obstructive pulmonary disease, Estonia, Hoechst, Growth, Medical device, Therapy, Medical Devices Directive, In Practice Systems Limited, Inhalation, Business development, Asthma, Chronic lung disease, Friends, Hospital, MDD, CE, Physician, Lung, Security (finance), Pharmaceutical industry, COPD, EU

He will take a seat on the non-executive Board of VisionHealth.

Key Points: 
  • He will take a seat on the non-executive Board of VisionHealth.
  • The study is designed as a randomly controlled, multi-centric trial over the period of one year with around 120 patients suffering from chronic respiratory diseases such as asthma or COPD.
  • It is truly rewarding to see how we can make a difference for patients and improve health outcomes.
  • Worldwide, Kata® could support the therapy of approximately 250 million patients suffering from chronic respiratory diseases, with an estimated 8.9 million cases alone in Germany.8,9

$6.47+ Billion Worldwide Track and Trace Solutions Industry to 2031 - Stringent Regulations and Standards for the Implementation of Serialisation Drives Growth - ResearchAndMarkets.com

Retrieved on: 
Friday, January 27, 2023
Transport, Logistics, Supply Chain Management, Benchmark, Organization, Insurance, Coronavirus, European Commission, Government, MDR, Create, RFID, GS1, Safety, Hardware, Civil service commission, Inspection, Acquisition, ACG Group, Aggregation, Food, Fresenius (company), MDD, Marketing, Growth, Health, EU, Medical device, European, Medical Devices Directive, Satellite navigation device, Warehouse, Zeiser

This report provides strategists, marketers and senior management with the critical information they need to assess the global track and trace solutions market.

Key Points: 
  • This report provides strategists, marketers and senior management with the critical information they need to assess the global track and trace solutions market.
  • The main types of products in the track and trace solutions market are hardware systems and software solutions.
  • Stringent regulations and standards for the implementation of serialisation are expected to propel the growth of the track and trace solutions market going forward.
  • Therefore, stringent regulations and standards for the implementation of serialization are driving the track and trace solutions market.

Track and Trace Solutions Global Market Report 2022: by Product Type, Technology, Application, End-use and Region

Retrieved on: 
Saturday, January 28, 2023
Benchmark, Safety, Civil service commission, Marketing, Coronavirus, Health, 2D, Fresenius (company), Medical Devices Directive, European Commission, Government, EU, Aggregation, RFID, ACG Group, Food, MDR, GS1, Insurance, Growth, Application, MDD, Inspection, Organization, Acquisition, Create, European, Medical device, Hardware, Cryptocurrency, Video game, Satellite navigation device, Warehouse, Zeiser

DUBLIN, Jan. 27, 2023 /PRNewswire/ -- The "Track And Trace Solutions Global Market Report 2022" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Jan. 27, 2023 /PRNewswire/ -- The "Track And Trace Solutions Global Market Report 2022" report has been added to ResearchAndMarkets.com's offering.
  • This report provides strategists, marketers and senior management with the critical information they need to assess the global track and trace solutions market.
  • Global Track And Trace Solutions Market, Segmentation By Product Type, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
    6.2.
  • Global Track And Trace Solutions Market, Segmentation By End Use, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

Ada Health Receives EU-MDR Certification for AI-Powered Symptom Assessment Platform

Retrieved on: 
Thursday, December 15, 2022
Certification, Ada Health, Medical Devices Directive, QMS, Public health, Royal commission, Patient, Entrepreneurship, Classification, ISO, SD, Medical device, Notified body, ISO 13485, AI, SSO, European Commission, Ada, Health, IIA, Safety, MDD, EU

NEW YORK and BERLIN, Dec. 15, 2022 /PRNewswire/ -- Ada Health GmbH ('Ada Health') the global digital health company focused on improving human health at scale, today announces that Ada Assess has successfully been certified as a Class IIa medical device under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR).

Key Points: 
  • NEW YORK and BERLIN, Dec. 15, 2022 /PRNewswire/ -- Ada Health GmbH ('Ada Health') the global digital health company focused on improving human health at scale, today announces that Ada Assess has successfully been certified as a Class IIa medical device under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR).
  • The Ada Assess enterprise solution is among the first AI-based symptom assessment platforms to be certified as a Class IIa medical device.
  • To secure Class IIa classification, Ada Health had to consistently demonstrate that its Ada Assess solution, and quality management system (QMS) meet the EU-MDR's rigorous standards for safety and effectiveness.
  • Ada is a global health company founded by doctors, scientists, and industry pioneers to create new possibilities for personal health and transform knowledge into better outcomes.

Ada Health Receives EU-MDR Certification for AI-Powered Symptom Assessment Platform

Retrieved on: 
Thursday, December 15, 2022
Certification, Ada Health, Medical Devices Directive, QMS, Public health, Royal commission, Patient, Entrepreneurship, Classification, ISO, SD, Medical device, Notified body, ISO 13485, AI, SSO, European Commission, Ada, Health, IIA, Safety, MDD, EU

NEW YORK and BERLIN, Dec. 15, 2022 /PRNewswire/ -- Ada Health GmbH ('Ada Health') the global digital health company focused on improving human health at scale, today announces that Ada Assess has successfully been certified as a Class IIa medical device under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR).

Key Points: 
  • NEW YORK and BERLIN, Dec. 15, 2022 /PRNewswire/ -- Ada Health GmbH ('Ada Health') the global digital health company focused on improving human health at scale, today announces that Ada Assess has successfully been certified as a Class IIa medical device under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR).
  • The Ada Assess enterprise solution is among the first AI-based symptom assessment platforms to be certified as a Class IIa medical device.
  • To secure Class IIa classification, Ada Health had to consistently demonstrate that its Ada Assess solution, and quality management system (QMS) meet the EU-MDR's rigorous standards for safety and effectiveness.
  • Ada is a global health company founded by doctors, scientists, and industry pioneers to create new possibilities for personal health and transform knowledge into better outcomes.