Medical device regulation

Airdoc Technology (2251.HK) Receives EU CE MDR Certification, Securing Market Access in Multiple Countries

Retrieved on: 
Tuesday, January 30, 2024
Diabetes, Certification, Patient, MDR, Incidence, Health, Diagnosis, Risk, International, Diabetic retinopathy, Disability, News, Travel, Medical device regulation, Conditional sentence, Finance, Prediabetes, National Medical Products Administration, CE, Prevalence, Medical device

Airdoc Technology (2251.HK) Receives EU CE MDR Certification, Securing Market Access in Multiple Countries

Key Points: 
  • Airdoc Technology (2251.HK) Receives EU CE MDR Certification, Securing Market Access in Multiple Countries
    On January 8th, Airdoc Technology announced that its Airdoc-AIFUNDUS (1.0) has recently obtained the CE marking ("CE MDR") as per the Medical Device Regulation, allowing comprehensive market entry into 27 EU countries, including Belgium, Germany, Italy, France, and more.
  • AI-FUNDUSCAMERA-P has obtained regulatory approval or registration in Indonesia, South Africa, the United Arab Emirates, and Thailand.
  • The company's self-developed AI-FD16 series of fundus cameras is China's first fully automatic, self-service, portable fundus camera to be approved for market release.
  • With market access permits obtained from various countries and regions, China's original AI technology is set to travel across the globe, benefiting local residents and making health ubiquitous.

Intensive 1 Day Virtual Course on Introduction to Human Factors for Pharmaceutical and Medical Device Professionals: Ethics, Consent and User Safety Along with How ISO 14971:2019 is Used - ResearchAndMarkets.com

Retrieved on: 
Wednesday, November 22, 2023
Pharmaceutical, Health, Medical Devices, Regulatory affairs, Risk management, Title, Medical device regulation, Anthropometry, CFR, IEC, Ethics, ISO, Peter Hancock (professor), Medication, Medical device, Usability, Human factors and ergonomics, Code, Medical Device Regulation Act

The "An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals" conference has been added to ResearchAndMarkets.com's offering.
  • This intensive one-day course will introduce those who are new to medical device design and development to the critical elements of the human factors and usability engineering process.
  • A focus on ethics, consent and user safety shall be described, along with how ISO 14971:2019 is used alongside any human factors process.
  • Post-market surveillance human factors shall also be detailed since this area is becoming increasingly important to include.

Lunit Nets FDA Nod for AI-Powered 3D Breast Tomosynthesis Solution, Lunit INSIGHT DBT

Retrieved on: 
Tuesday, November 14, 2023
Food and Drug Administration, Food, Medical device regulation, MDR, Mammography Quality Standards Act, Breast cancer, FDA, Therapy, 2D, INSIGHT, Diagnosis, 3D, DBT, Medical device, Medical imaging

SEOUL, South Korea, Nov. 14, 2023 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its 3D Breast Tomosynthesis (DBT) AI solution, Lunit INSIGHT DBT. This approval signifies a major step forward in the fight against breast cancer, enabling Lunit to make a full-fledged entry into the US breast screening market.

Key Points: 
  • - Lunit INSIGHT DBT receives FDA 510(k) clearance, poised to enter the world's largest DBT market
    SEOUL, South Korea, Nov. 14, 2023 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its 3D Breast Tomosynthesis (DBT) AI solution, Lunit INSIGHT DBT.
  • Lunit INSIGHT DBT is an AI algorithm engineered to analyze 3D images generated by DBT equipment.
  • This FDA clearance follows Lunit's previous achievements in November 2021, when it received FDA clearance for its chest X-ray triage solution 'Lunit INSIGHT CXR Triage' and for its AI-powered mammography analysis solution 'Lunit INSIGHT MMG.'
  • In addition, Lunit INSIGHT DBT has been cleared for Europe by being CE-marked under Europe's latest Medical Device Regulation (EU MDR) since March 2023.

BellaSeno Presents Novel Production Workflow for Customized, 3D-Printed Bone Scaffolds

Retrieved on: 
Monday, October 30, 2023
FDM, Medical device regulation, Medtech, MDR, Bone, Injury, CT, Workflow, Orthopedic surgery, ISO, Sterilization, 3D printing, Medical device, Traumatology

The presentation titled "Semi-automated workflow for the design and fabrication of 3D-printed patient-specific resorbable scaffolds for the treatment of large segmental bone defects while complying with MDR regulations" outlined the potential of BellaSeno´s novel resorbable scaffolds for curing large segmental bone defects (> 5cm size).

Key Points: 
  • The presentation titled "Semi-automated workflow for the design and fabrication of 3D-printed patient-specific resorbable scaffolds for the treatment of large segmental bone defects while complying with MDR regulations" outlined the potential of BellaSeno´s novel resorbable scaffolds for curing large segmental bone defects (> 5cm size).
  • The scaffold is needed to hold the autologous bone graft in position for optimal vascularization and bone healing.
  • Scaffolds made by additive manufacturing from bioresorbable polymers represents a highly attractive opportunity to produce such patient-specific open-pore scaffolds.
  • This results in a new generation of high-performance bone scaffolds which are well suited for the biological reconstruction of large bone defects."

Medical Device Development and Market Strategy: Europe or US First? Or Both? Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Monday, October 23, 2023
US FDA, IVDR, Medtech, MDR, Medical device regulation, Regulatory affairs, Medical device, EU

TORONTO, Oct. 23, 2023 /PRNewswire-PRWeb/ -- Historically, medical device developers often opted to bring new products to market in the EU first, as obtaining a CE mark was perceived to be faster, less expensive and more predictable than getting US FDA clearance or approval. With the introduction of the EU's Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), the paradigm has shifted, and an increasing number of medical device companies are prioritizing the US market. However, the decision of where to launch first must be guided by more than just regulatory requirements.

Key Points: 
  • Medical Device Development and Market Strategy: Europe or US First?
  • Upcoming Webinar Hosted by Xtalks
    TORONTO, Oct. 23, 2023 /PRNewswire-PRWeb/ -- Historically, medical device developers often opted to bring new products to market in the EU first, as obtaining a CE mark was perceived to be faster, less expensive and more predictable than getting US FDA clearance or approval.
  • With the introduction of the EU's Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), the paradigm has shifted, and an increasing number of medical device companies are prioritizing the US market.
  • In this webinar, the featured speakers will explore key considerations for prioritizing markets and optimizing the path to product launch.

EQS-News: Marinomed Biotech AG resumes Nice & Green Convertible Notes Funding Program with reduced volume

Retrieved on: 
Tuesday, October 17, 2023
Nice, Convertible, MDR, Environment, Medical device regulation, VSE, CFO, Negotiation, Security (finance)

Korneuburg, Austria, October 17, 2023 – Marinomed Biotech AG (VSE:MARI) has taken steps to further increase the flexibility of its corporate financing.

Key Points: 
  • Korneuburg, Austria, October 17, 2023 – Marinomed Biotech AG (VSE:MARI) has taken steps to further increase the flexibility of its corporate financing.
  • Marinomed has agreed on an adjustment of the Convertible Notes Funding Program running since October 2021 (initial maturity September 2023) and its extension until October 2024 with the Swiss investment company Nice & Green S.A.
  • So far, 50% of the original program volume of €5.4 million in convertible bonds have been issued and converted into ordinary shares of Marinomed.
  • Pascal Schmidt, CFO of Marinomed, comments: “I am pleased that the cooperation with Nice & Green remains constructive and flexible.

Moon Surgical Announces CE Mark for Its Commercial Maestro System

Retrieved on: 
Tuesday, September 19, 2023
Technology, Surgery, Medical Devices, Hospitals, Science, Biotechnology, Health, Robotics, Health Technology, Other Science, Apps, Applications, Research, Other Technology, Software, Other Health, Hardware, Data Management, Surgeon, Sofinnova, CE marking, Maestro, Multimedia, Medical Device Regulation Act, Medical device regulation, Partner, Patient, Medical device, Dentistry, EU

Moon Surgical , a French-American pioneer in collaborative robotics, announced today that the latest version of its Maestro System is CE Marked under the Medical Device Regulation (EU) 2017/745.

Key Points: 
  • Moon Surgical , a French-American pioneer in collaborative robotics, announced today that the latest version of its Maestro System is CE Marked under the Medical Device Regulation (EU) 2017/745.
  • View the full release here: https://www.businesswire.com/news/home/20230919460931/en/
    The latest version of the Maestro Surgical Robotics System by Moon Surgical, now also carries the CE Mark.
  • The Maestro System is designed to provide an accessible and enhanced version of traditional laparoscopy to over 18 million patients undergoing soft tissue procedures annually who currently lack the benefits of robotic surgical platforms.
  • The initial version of the Maestro System obtained its CE Mark earlier this April.

Body Vision Medical Receives EU-MDR Certification for LungVision™ AI-Powered Image Guidance Platform

Retrieved on: 
Tuesday, September 19, 2023
CT, Medical device regulation, Medical Devices Directive, Lung cancer, Gesellschaft mit beschränkter Haftung, Certification, MDR, MDD, Patient, Artificial intelligence, European Medical Devices Industry Group, Safety, Medical device, EU

CAMPBELL, Calif., Sept. 19, 2023 /PRNewswire/ -- Body Vision Medical, a leader in AI-driven intraoperative imaging announced today that its latest generation LungVision™ AI-powered lung navigation and real-time imaging platform has been granted certification as a Class IIa medical device under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR). The certification, issued by mdc medical device certification GmbH on September 18, 2023, makes Body Vision the first company worldwide in the industry of lung navigation and real-time imaging to obtain the new European Medical Device Regulation (MDR) Certification recommendation.

Key Points: 
  • CAMPBELL, Calif., Sept. 19, 2023 /PRNewswire/ -- Body Vision Medical, a leader in AI-driven intraoperative imaging announced today that its latest generation LungVision™ AI-powered lung navigation and real-time imaging platform has been granted certification as a Class IIa medical device under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR).
  • The certification, issued by mdc medical device certification GmbH on September 18, 2023, makes Body Vision the first company worldwide in the industry of lung navigation and real-time imaging to obtain the new European Medical Device Regulation (MDR) Certification recommendation.
  • Over the past several years, regulations for medical device manufacturers have become progressively more complex and demanding.
  • "The EU-MDR is one of the world's most robust health tech regulations and plays a vital role in ensuring medical devices meet the highest standards," said Matt Baker, Chief Operating Officer for Body Vision Medical.

Implantica receives MDR certification for RefluxStop™

Retrieved on: 
Thursday, September 7, 2023
BSI, QMS, Civil service commission, Notified body, Medical device regulation, Certification, MDR, Patient, European Commission, Medical device, EU

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.

Medimaps Group Receives EU Certification Under the Medical Device Regulation

Retrieved on: 
Monday, September 4, 2023
Technology, Medical Devices, Other Technology, Software, Biotechnology, Other Health, Health, General Health, Artificial Intelligence, CE, CT, Radiation, BSI, CPT, Osteoporosis, TBS, Multimedia, BMD, Medical Device Regulation Act, Medical device regulation, Certification, DXA, MDR, X-ray, Patient, Calvarial doughnut lesions-bone fragility syndrome, AI, EEC, FDA, Safety, Medical device, Medical imaging

Medimaps Group, a Swiss/Global med-tech company specializing in image-processing software with AI capabilities for assessing bone health, announced today it received the Medical Device Regulation (MDR) certification from its notified body BSI (CE 2797) for its management system and product portfolio.

Key Points: 
  • Medimaps Group, a Swiss/Global med-tech company specializing in image-processing software with AI capabilities for assessing bone health, announced today it received the Medical Device Regulation (MDR) certification from its notified body BSI (CE 2797) for its management system and product portfolio.
  • By successfully navigating the rigorous requirements of the Medical Device Regulation, our company proves its ability to deliver innovative and reliable solutions that meet the highest regulatory standards for the benefit of patients, healthcare professionals and medical business partners”, said Prof. Didier Hans, co-founder and CEO of Medimaps Group.
  • The certification ensures that medical device manufacturers meet the most stringent quality requirements in order to commercialize their products in Europe.
  • With this certification, Medimaps Group can continue to supply without interruptions certified TBS iNsight™ software at the highest standard to its valued customers in Europe and subsequent markets.