Medical Device Regulation Act

Regen Lab Announces the Obtention of the New CE Certification Under Medical Device Regulation (EU MDR 2017/745) Validating the Safety and Performance of Its Proprietary Best-in-class PRP Solutions, Alone or Combined With Hyaluronic Acid

Retrieved on: 
Montag, Mai 15, 2023
Research, Medical Devices, Engineering, Manufacturing, Biotechnology, Other Health, Health, Other Science, Science, CE, BSI, Medical device, Platelet-rich plasma, Public, HA, MDSAP, Technical documentation, Certification, Hyaluronic acid, MDR, MDD, PRP, Patient, European, Patient safety, Quality assurance, European Medical Devices Industry Group, Medical Device Regulation Act, Safety, Le Mont-sur-Lausanne, Syringe, Foodservice, EU

REGENKIT® is a preparation of Platelet-Rich Plasma (PRP), CELLULAR MATRIX fig®, a combination of PRP and Hyaluronic Acid (HA), and Arthrovisc®, HA filled syringes.

Key Points: 
  • REGENKIT® is a preparation of Platelet-Rich Plasma (PRP), CELLULAR MATRIX fig®, a combination of PRP and Hyaluronic Acid (HA), and Arthrovisc®, HA filled syringes.
  • These EU regulations on medical devices aim at establishing a modern and more robust regulatory framework to protect public health and patient safety.
  • The certifications obtained reinforces Regenlab’s competitive position in the PRP market alone and in combination with HA.
  • Regen Lab is a vertically integrated group with extensive R&D, regulatory and manufacturing expertise.

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

Retrieved on: 
Donnerstag, 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.

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

Retrieved on: 
Donnerstag, 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.

Fresenius Kabi Launches Single-Needle Option for the Amicus® Extracorporeal Photopheresis Protocol

Retrieved on: 
Sonntag, April 23, 2023
Pharmaceutical, Medical Supplies, Surgery, Oncology, Health, Diabetes, Medical Devices, Hospitals, CE, TPE, Fresenius (company), ECP, Cutaneous T-cell lymphoma, CTCL, Amicus, Medical Device Regulation Act, Kabi, Sale, Medical device regulation, MNC, Patient, Collection, Physician, Skin, Medical device, EU

Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.

Key Points: 
  • Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.
  • The Amicus Blue System with online ECP was launched in Europe in 2019 with double-needle venous access only.
  • “We are thrilled to enable the single-needle option for the Amicus Blue ECP system, which will allow physicians to treat patients with limited venous access.
  • This builds on our Amicus Blue vision to provide a versatile, multi-procedural instrument to support patients’ individual needs,” said Christian Hauer, President Fresenius Kabi MedTech.

Advancing Precision Care: GE HealthCare Introduces an Innovative Solution to Help Expand Interventional CT Access

Retrieved on: 
Dienstag, April 18, 2023
Oncology, Health, Neurology, Health Technology, Radiology, Biotechnology, IGT, GE HealthCare, Radiation, GPS, University, Therapy, Workflow, Drainage, Neoplasm, Anatomy, Molecular imaging, Learning curve, University of Pisa, GE, Needle, CT scan, Number One, MDR, Motion, Interventional radiology, Acquisition, European Conference on Information Retrieval, Patient, Division, European, Risk, Interventional oncology, Institut de radioprotection et de sûreté nucléaire, Diagnosis, FDA, Medical Device Regulation Act, Conference, Safety, Biopsy, Disease, Medical imaging, Medical device

Interventional radiology – and specifically interventional CT – plays a key role in the diagnosis and treatment of disease.

Key Points: 
  • Interventional radiology – and specifically interventional CT – plays a key role in the diagnosis and treatment of disease.
  • Instead of working wholly within the CT system’s narrow bore, interventionalists using CT-Navigation can simply place a sensor on the patient inside the gantry.
  • Today, the innovative solution focuses solely on CT applications, but GE HealthCare plans to expand the technology to its image guided therapy (IGT) business in the near future – further advancing its clinical application and reach.
  • Additionally, GE HealthCare is showcasing CT-Navigation at the European Conference on Interventional Oncology (ECIO) in Stockholm, Sweden.

Celluma Light Therapy Receives EU-MDR Certification

Retrieved on: 
Dienstag, 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.

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

Retrieved on: 
Donnerstag, März 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.

IMed Consultancy releases guide to Post Market Surveillance to help medical device businesses keep on track with compliance despite delays

Retrieved on: 
Donnerstag, März 2, 2023
Qualified Person Responsible For Pharmacovigilance, Classification, PMS, IVDR, Medical Device Regulation Act, Patient safety, Quality, Surveillance capitalism, Notified body, MDR, Medical device, EU

OXFORD, England, March 2, 2023 /PRNewswire/ -- IMed Consultancy, a rising regulatory and compliance consultancy provider with over 50 years of experience supporting UK and international medical device and invitro device manufacturers launch and maintain their products on global markets, has pooled in-house expertise to develop a free practical guide to Post Market Surveillance. The simple guide, available here: https://imedconsultancy.com, outlines the scope of the task, supporting manufacturers who are still getting to grips with developing a best-practice PMS strategy.

Key Points: 
  • The simple guide, available here: https://imedconsultancy.com , outlines the scope of the task, supporting manufacturers who are still getting to grips with developing a best-practice PMS strategy.
  • Similarly, transition to full IVDR compliance has been rescheduled according to the classification of the device.
  • Medical device manufacturers would thus do well to devote this grace period to focus on perfecting their PMS strategy, specifically focusing on understanding its scope.
  • In reality, proactive PMS is already a requirement so now is the perfect time to get to grips with this key part of compliance.

Hyperfine, Inc. Swoop® Portable MR Imaging® System Receives CE Marking After Meeting Comprehensive New EU MDR Regulations

Retrieved on: 
Dienstag, Februar 21, 2023
CER, Medical Device Regulation Act, Regulation (European Union), MDR, MRI, Safety, European Economic Area, Medical device regulation, FDA, CE marking, Hyperfine structure, Medical device, EEA, EU

GUILFORD, Conn., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that created the Swoop® system, the world's first FDA-cleared portable MRI system, today announced CE Marking for the product.

Key Points: 
  • GUILFORD, Conn., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that created the Swoop® system, the world's first FDA-cleared portable MRI system, today announced CE Marking for the product.
  • While the company will maintain its commercial focus in the U.S. in 2023, CE Marking opens the door for potential future commercial expansion into the European Economic Area (EEA).
  • To receive CE Marking, medical device companies must comply with the European Commission Regulation (EU) No.
  • EU MDR dictates the European distribution of medical devices, and compliance is mandatory to legally market and sell products in the EEA.

GE HealthCare Announces Agreement to Acquire IMACTIS to Strengthen Capabilities in Interventional Guidance

Retrieved on: 
Montag, Januar 9, 2023
Medical Devices, Health, Radiology, Health Technology, Medical Supplies, IGT, Hospital, MDR, Hand, Nephrology, FDA, GE, Cardiology, Shearman & Sterling, Diagnosis, Growth, Patient, Urology, Software, Medical Device Regulation Act, Interventional radiology, Oncology, Workflow, Acquisition, Intervention, GE Healthcare, European, Physician, Medical imaging, Imaging

GE HealthCare (Nasdaq: GEHC) today announced it has entered into an agreement to acquire IMACTIS, an innovator in the rapidly growing field of computed tomography (CT) interventional guidance across an array of care areas.

Key Points: 
  • GE HealthCare (Nasdaq: GEHC) today announced it has entered into an agreement to acquire IMACTIS, an innovator in the rapidly growing field of computed tomography (CT) interventional guidance across an array of care areas.
  • “We’re thrilled to take this step in strengthening our interventional guidance offering for patients and customers,” said Jan Makela, President and CEO of Imaging, GE HealthCare.
  • The global Interventional Radiology market includes CT interventional guidance, and the IMACTIS acquisition provides GE HealthCare with access to this growing opportunity.
  • Shearman & Sterling LLP acted as legal advisor to GE HealthCare.