Medical device regulation

Implantica receives MDR certification for RefluxStop™

Retrieved on: 
Donnerstag, 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: 
Montag, 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.

OrbusNeich FY2023 Interim Net Profit Triples to US$25.2 Million, Total Revenue Increases by 18.2% to US$81.4 Million

Retrieved on: 
Donnerstag, August 17, 2023
Percutaneous coronary intervention, CE, Medical device, PTA, Marketing, Medical Devices Directive, ISO, Abbott, CE marking, Clinical trial, Sapphire, Quality of life, OrbusNeich, Medical device regulation, Certification, PCI, MDR, Acquisition, MDD, Patient, Developed country, Physician, PMDA, FX, Capacity, Teleport, Growth, R, FDA, Family, NMPA, Renewable energy, Pharmaceutical industry, PRC

Gross profit rose by 22.1% to approximately US$58.3 million, with a gross profit margin of 71.6%.

Key Points: 
  • Gross profit rose by 22.1% to approximately US$58.3 million, with a gross profit margin of 71.6%.
  • As a result, profit attributable to the owners of the Company reached US$25.2 million, an increase of 213.3%, with a net profit margin of 30.9%.
  • Adjusted profit (non-HKFRS measure) (1) increased by 105.6% year-on-year to approximately US$25.4 million.
  • As at 30 June 2023, the Group was in a strong financial position with cash and bank balances of approximately US$239.0 million.

New Microbiology and Chemistry Laboratory Opens to Accelerate Scientific Discovery

Retrieved on: 
Mittwoch, Juli 5, 2023
Medical Supplies, Health, Medical Devices, Other Science, Research, Science, Biotechnology, Breakfast, Medical device, IVDR, ISO, Water, Carbon, BACS, Medical Device Regulation Act, Language, Board of Management St. Molaga's National School v The Secretary General of the Department of Education and Science, Medical device regulation, Certification, Chemistry, MDR, Medtech, Microbiology, Renewable energy

The laboratory will enable domestic and international medical device companies to accelerate their research and development by providing testing services in the areas of microbiology, reusable device testing, chemistry, biocompatibility and packaging.

Key Points: 
  • The laboratory will enable domestic and international medical device companies to accelerate their research and development by providing testing services in the areas of microbiology, reusable device testing, chemistry, biocompatibility and packaging.
  • “The opening of the New Brighton laboratory is a significant milestone for TÜV SÜD and a further addition to our laboratory network around the globe.
  • “We are proud to open this new laboratory and to continue our tradition of innovation and excellence in the healthcare industry.
  • Our expert laboratory staff is eager to provide compliant quality results for our medical device testing customers.

Luciole Medical AG Announces the Acquisition of Spiegelberg GmbH & Co. KG to Create a Leading Global Brain Monitoring Developer and Provider

Retrieved on: 
Dienstag, Juni 27, 2023
Science, Neurology, Biotechnology, Research, Medical Supplies, Health, Medical Devices, Hospitals, CE, Medicine, Stroke, Brain, Speech, Spiegelberg, Dementia, Medical device regulation, Paralysis, MDR, Hospital, Acquisition, Neurosurgery, Patient, Coma, Diagnosis, Death, ICP, Intracranial pressure, Medical device, Medical imaging, Colomban MC-30 Luciole

Luciole Medical AG , a Swiss medical technology company specialized in brain monitoring, today announced the acquisition of Spiegelberg GmbH & Co. KG (Spiegelberg), an established medical device company and provider of highly specialized devices and consumables for neurosurgery, from SHS Capital.

Key Points: 
  • Luciole Medical AG , a Swiss medical technology company specialized in brain monitoring, today announced the acquisition of Spiegelberg GmbH & Co. KG (Spiegelberg), an established medical device company and provider of highly specialized devices and consumables for neurosurgery, from SHS Capital.
  • Following the acquisition, the companies will combine their product suites, manufacturing, and distribution channels to optimize their strengths aiming at becoming a global leader in providing innovative next-generation brain monitoring devices.
  • The company works with recognized research institutes, leading clinics, and specialists in neurosurgery to develop products that are best tailored to the patient.
  • Luciole Medical will leverage Spiegelberg’s manufacturing, regulatory, and commercial capabilities, including its global supply network, to bring improved brain monitoring devices to a broad patient population.

EQS-News: Marinomed Biotech AG prepares launch of Carragelose eye drops in 2024

Retrieved on: 
Donnerstag, Juni 15, 2023
Medical device, Partnership, Marketing, Medical Devices Directive, Eye, Clinical trial, Medical device regulation, Certification, MDR, MDD, VSE, OTC, Security (finance), EU

Korneuburg, Austria, 15 June 2023 – Marinomed Biotech AG (VSE:MARI), announced today the introduction of a new Carragelose eye drop product (MAM-1001-3), expanding the range of the marketed Carragelose OTC portfolio.

Key Points: 
  • Korneuburg, Austria, 15 June 2023 – Marinomed Biotech AG (VSE:MARI), announced today the introduction of a new Carragelose eye drop product (MAM-1001-3), expanding the range of the marketed Carragelose OTC portfolio.
  • The product has a valid certification under the Medical Device Directive (MDD) and is currently being prepared for marketing.
  • With a first partnership for the eye drops already in place, a market launch in Austria is targeted for the first half of 2024.
  • “The introduction of Carragelose eye drops is a logical addition to our current OTC portfolio.

New Microbiology and Chemistry Laboratory Gets Accredited under ISO/IEC 17025:2017

Retrieved on: 
Mittwoch, Mai 31, 2023
Biotechnology, Medical Devices, Other Health, Health, Medical Supplies, Medicine, Calibration, IVDR, Accreditation, Microbiology, ISO/IEC 17025, Element, ISO/IEC, Electricity, 2005 in television, National Voluntary Laboratory Accreditation Program, Research, Carbon, Medical Device Regulation Act, Instrument, Language, Medical device regulation, SVOC, Certification, MDR, ISO, Metal, Health care, Kinetic, Laboratory, Botswana Private Medical & Health Services Workers' Union, GCMS, USB On-The-Go, Versata Development Group, Inc. v. SAP America, Inc., CO2, Incubation, Medical device, Renewable energy, Cytotoxicity, Enumeration, Chemistry, Biocompatibility

TÜV SÜD America Inc., a leading provider of certification, auditing and testing services, has been accredited under American Association for Laboratory Accreditation (A2LA) ISO/IEC 17025:2017 Accreditation.

Key Points: 
  • TÜV SÜD America Inc., a leading provider of certification, auditing and testing services, has been accredited under American Association for Laboratory Accreditation (A2LA) ISO/IEC 17025:2017 Accreditation.
  • The laboratory enables domestic and international medical device companies to accelerate their research and development by providing testing services in the areas of microbiology, reusable device testing, chemistry, biocompatibility and packaging.
  • ISO/IEC 17025:2017 is the international standard for testing and calibration laboratories, and it outlines the requirements for the competence, impartiality, and validity of laboratory results.
  • A wide range of testing is covered including Chemistry, Microbiology, Water Testing, Bioburden, Biocompatibility, and Cytotoxicity.

InspireMD Reports First Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Dienstag, Mai 16, 2023
Medical device, Marketing, Stenosis, Stroke, CE marking, CAD, Medical device regulation, MRD, TEL, NSPR, Medical Devices Directive, MDR, Clinical trial, ...Continued, MDD, Patient, Growth, EPS, IDE, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Global marketing, Food, Beauty salon, Cryptocurrency, Pharmaceutical industry, Video game, EU

Generated CGuard revenue for the first quarter 2023 of $1,239,064, a 6.7% increase over the same period in 2022.

Key Points: 
  • Generated CGuard revenue for the first quarter 2023 of $1,239,064, a 6.7% increase over the same period in 2022.
  • Sold 2,033 CGuard EPS stent systems in the first quarter of 2023, as compared to 1,910 in the first quarter of 2022, an increase of 6.4%.
  • Total operating expenses for the first quarter of 2023, were $4,754,000, an increase of $146,000 or 3.2% compared to $4,608,000 for the first quarter of 2022.
  • Management will host a conference call today, Tuesday, May 16th, at 8:30 AM ET, to review financial results and provide an update on corporate developments.

Neuronetics Receives MDSAP Certification and CE Mark Certification under New MDR

Retrieved on: 
Montag, Mai 8, 2023
Marketing, CE marking, Quality of life, MDSAP, Medical device regulation, Certification, STIM, MDR, Patient, Patient safety, European, Medical device, European Medical Students' Association, EU, Neuronetics

The Company has received CE Mark Certification for NeuroStar Advanced Therapy under the new Medical Device Regulation (MDR) in the European Union (EU) and the Medical Device Single Audit Program (MDSAP) certification.

Key Points: 
  • The Company has received CE Mark Certification for NeuroStar Advanced Therapy under the new Medical Device Regulation (MDR) in the European Union (EU) and the Medical Device Single Audit Program (MDSAP) certification.
  • The process is designed to improve patient safety and ensure the effectiveness and quality of medical devices sold in the EU.
  • The CE Mark is a symbol that indicates conformity with EU regulations, and it is a mandatory requirement for medical devices to be sold in the EU.
  • MDSAP certification covers distribution in five countries, including the U.S., Japan, Canada, Australia, and Brazil.

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.