European Medical Writers Association

Inogen Achieves Regulatory Milestones to Support Current and Future Products

Retrieved on: 
Tuesday, January 10, 2023
Biotechnology, FDA, Medical Devices, Health, Health Technology, European Medical Writers Association, Overalls, BSI, MDR, POC, Certification, FDA, Pocs, Food and Drug Administration, US FDA, Food, Notified body, Patient, COPD, Rove, Medical device, EU

(Nasdaq: INGN ), a medical technology company offering innovative respiratory products for use in the homecare setting, today announced that it has achieved regulatory milestones in the EU and the US to support its portable oxygen concentrator products.

Key Points: 
  • (Nasdaq: INGN ), a medical technology company offering innovative respiratory products for use in the homecare setting, today announced that it has achieved regulatory milestones in the EU and the US to support its portable oxygen concentrator products.
  • Inogen received European Medical Device Regulation (EU MDR) certification from its Notified Body, the British Standards Institution (BSI) in December 2022, granting permission to sell and commercialize Inogen One G4 and the updated version of its Inogen One G5 portable oxygen concentrators in the EU.
  • These regulatory achievements enhance Inogen’s portfolio of portable oxygen concentrator products with the addition of the Rove series.
  • We are excited about these new products and the progress in the overall innovation roadmap towards next generation offerings to serve COPD patients and beyond.”

Asensus Surgical Provides Preliminary 2022 Year-End Corporate Update

Retrieved on: 
Monday, January 9, 2023
ISU, European Medical Writers Association, PARK, MDR, PMDA, Image, CE marking, Digital, Leonardo da Vinci, Operation Time, GYN, Anatomy, Surgeon, NYSE, 3D, Kitakyushu, U.S. FDA, Growth, Acceleration, Patient, Urology, Sale, General surgery, Freedom, RESEARCH, Gynaecology, TRUST, CIS, Investment, Dentistry, Medical device, Security (finance), Video game, Medicine

RESEARCH TRIANGLE PARK, N.C., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today provided a preliminary 2022 year-end corporate update.

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today provided a preliminary 2022 year-end corporate update.
  • During the fourth quarter of 2022, the Company initiated five new Senhance Surgical System placements, two in Germany, two in Japan, and one in the CIS region.
  • In 2022, the Company initiated nine new Senhance Surgical System placements: four in Germany, three in Japan, and two in the CIS region.
  • For the quarter ended December 31, 2022, the Company estimates preliminary unaudited revenue of approximately $2.2 - $2.8 million.

BrainTale Has Presented the Interest If Its Digital Biomarkers Platform in Differential Diagnosis During the 15th Edition of Clinical Trials on Alzheimer’s Disease Conference

Retrieved on: 
Monday, December 5, 2022
Medical Devices, Health, Neurology, Other Health, Clinical Trials, Biotechnology, Hospital, Neurological disorder, Degenerative disease, Physician, Neurodegeneration, Clinical trial, Disease, Amyotrophic lateral sclerosis, Diagnosis, Diffusion, Dementia, Biomarker, Patient, ISO, Research, CSO, White matter, HIV disease progression rates, Neurology, Incidence, MDR, European Medical Writers Association, Axon, Ageing, Adaptive clinical trial, Brain, Myelin, Risk, Medical imaging, Pharmaceutical industry, Medical device, Alzheimer's disease

Alzheimers disease affects about 10 million people per year worldwide and its incidence rate tends to increase year after year.

Key Points: 
  • Alzheimers disease affects about 10 million people per year worldwide and its incidence rate tends to increase year after year.
  • Results show that BrainTale biomarkers are relevant biomarkers of disease severity, and that the platform has the potential for a differentiated diagnosis perspective.
  • Our data suggest a very exciting complementary approach to existing initiatives to better diagnose, and ultimately better treat Alzheimers disease patients.
  • With non-invasive, sensitive and reliable measurements of white matter microstructure alterations, BrainTale offers a digital biomarkers platform to support clinical decision-making.

Insulet Announces CE Mark Approval for Omnipod® 5 Automated Insulin Delivery System

Retrieved on: 
Tuesday, September 20, 2022
Biotechnology, Pharmaceutical, General Health, Health, Diabetes, Medical Devices, Consumer Electronics, Technology, Risk, POD, Safety, Injection, 5, Insulin pump, Corporation, Company, European Association for the Study of Diabetes, Glucose, Diabetes, U.S. Securities and Exchange Commission, Paracetamol, Insulin, CEO, Technology, European Medical Writers Association, Annual report, CGM, T1D, NASDAQ, G6, Ageing, Security (finance), Association, EASD, Medical device, Pharmaceutical industry, Copper, Dexcom

Omnipod 5 is the first CE marked tubeless hybrid closed loop system (also known as automated insulin delivery) that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System to automatically adjust insulin and help protect against high and low glucose levels 1.

Key Points: 
  • Omnipod 5 is the first CE marked tubeless hybrid closed loop system (also known as automated insulin delivery) that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System to automatically adjust insulin and help protect against high and low glucose levels 1.
  • The system then increases, decreases, or pauses insulin delivery based on the users desired and customized glucose target.
  • The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods.
  • Insulets latest innovation, the Omnipod 5 Automated Insulin Delivery System, is a tubeless automated insulin delivery system, integrated with a continuous glucose monitor to manage blood sugar with no multiple daily injections and zero fingersticks3.

BVI Announces Certification for its Intraocular Lens Portfolio under the European Medical Device Regulation

Retrieved on: 
Thursday, September 15, 2022
MDR, Health, Safety, MDD, Intention, Medtech, IOL, Compliance, Knife, Partnership, Patient, Medical Devices Directive, Certification, CEO, European Medical Writers Association, Solution, EC, Surgeon, Quality assurance, GLOBE, Notified body, Product life-cycle theory, BSI, Medical device, Business operations, Nasal cannula, EU, BVI

WALTHAM, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) -- BVI, a diversified global ophthalmic device company, today announced certification for its intraocular lens (IOL) portfolio under the European Medical Device Regulation (MDR, (EU) 2017/745) from its Notified Body, the British Standards Institution (BSI).

Key Points: 
  • WALTHAM, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) -- BVI, a diversified global ophthalmic device company, today announced certification for its intraocular lens (IOL) portfolio under the European Medical Device Regulation (MDR, (EU) 2017/745) from its Notified Body, the British Standards Institution (BSI).
  • The new regulatory criteria came into effect in May 2021, replacing the prior Medical Device Directive (MDD).
  • The MDR, representing the most significant change to European regulatory framework in decades, ensures a consistently high level of health and safety for medical devices.
  • Achieving and maintaining MDR certification is a major effort that requires a tremendous amount of investment, capabilities, and hard work, said Shervin Korangy, BVI President and CEO.

Global Medical Device Outsourcing Market Report 2022: Increase in Off-Shoring Medical Device Manufacturing to Emerging Economies Driving Growth - ResearchAndMarkets.com

Retrieved on: 
Thursday, September 8, 2022
Medical Devices, Health, Cardiology, COVID-19, Contract, QMS, Original equipment manufacturer, Medicine, USD, Lists of countries and territories, General officer, IVD, Compliance, CAGR, European Medical Writers Association, Growth, Industry, Risk management, Medical device, EU

The global medical device outsourcing market size is expected to reach USD 292.93 billion by 2030, registering a CAGR of 12.1% during the forecast period.

Key Points: 
  • The global medical device outsourcing market size is expected to reach USD 292.93 billion by 2030, registering a CAGR of 12.1% during the forecast period.
  • The rising demand for advanced medical products and a growing trend of offshoring are fueling the growth of this market.
  • Various initiatives by public organizations promoting testing for COVID-19 are also enhancing market growth.
  • The contract manufacturing market dominated the global market in 2021 owing to the growing trend of outsourcing by OEMs to third-party manufacturers, especially in emerging countries.

Brain Scientific Announces CE Mark Approval for NeuroCap™ Device

Retrieved on: 
Wednesday, August 24, 2022
CEO, Government, OEM, EEG, Diagnosis, SEC, Electrode, Federal Food, Drug, and Cosmetic Act, Neurology, Hospital, GLOBE, Income, Stroke, FDA, Ambulance, Certification, Failure, Projection, European Medical Writers Association, Epilepsy, Public expenditure, CE, Environment, OTCQB, Forward-looking statement, Patient, Medical device

LAKEWOOD RANCH, Fla., Aug. 24, 2022 (GLOBE NEWSWIRE) -- via InvestorWire -- Brain Scientific ( OTCQB:BRSF ), a Florida-based medical device technology company, today announces receiving the Conformit Europenne (CE) Mark for the NeuroCap.

Key Points: 
  • LAKEWOOD RANCH, Fla., Aug. 24, 2022 (GLOBE NEWSWIRE) -- via InvestorWire -- Brain Scientific ( OTCQB:BRSF ), a Florida-based medical device technology company, today announces receiving the Conformit Europenne (CE) Mark for the NeuroCap.
  • The CE mark confirms that Brain Scientific meets all European Medical Device Directive requirements to begin commercializing its innovative neurological devices across the European Continent and other CE mark geographies.
  • The CE mark approval is yet another certification proving the effectiveness of Brain Scientifics technologies, said Daniel Cloutier, CEO of LOK Corporation.
  • We have seen strong demand from European neurologists and distributors for the NeuroCap, and now with the CE mark Brain Scientific can start selling to medical facilities in Europe.

Global Molecular Diagnostics Market Report 2022-2028: Increase in Demand for Point-of-Care and Developments by Market Players & Prevalence of Associated Diseases Driving Growth - ResearchAndMarkets.com

Retrieved on: 
Tuesday, August 9, 2022
Infectious Diseases, Biotechnology, Pharmaceutical, Health, Death, Animal and Plant Health Inspection Service, Global Burden of Disease Study, World Health Organization, Genetic testing, Mortality, Population, Technology, POC, European Medical Writers Association, American Cancer Society, Cancer, Infection, Hospital, Prevalence, Research, Food and Drug Administration, Patient, DNA, COVID-19, Lists of diseases, CVD, Polymerase chain reaction, Institute for Health Metrics and Evaluation, CAGR, WHO, World, Food safety, Software, European Medical Association, Food, Food Safety and Inspection Service, Pharmaceutical industry, Vaccine, Medical device

The "Molecular Diagnostics Market Forecast to 2028 - COVID-19 Impact and Global Analysis" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Molecular Diagnostics Market Forecast to 2028 - COVID-19 Impact and Global Analysis" report has been added to ResearchAndMarkets.com's offering.
  • The market growth is mainly attributed to an increase in demand for point-of-care devices, developments by market players, and a rise in the prevalence of associated diseases.
  • However, the increasing prevalence of associated diseases is expected to limit market growth.
  • Molecular diagnostics has wide applications in various indications such as oncology, infectious diseases, genetic testing, cardiac diseases, and immune system disorders.

Global Vaporizers Market Report 2022: Featuring Key Players Vicks, Vanker, GE Healthcare & Others - ResearchAndMarkets.com

Retrieved on: 
Monday, August 8, 2022
Medical Devices, Health, ECC, Vaporizer (inhalation device), Application, Technology, European Medical Writers Association, Growth, GE Healthcare, THC, Market share, Growth hacking, Water, Electricity, Distribution, Heat, Mighty, Temperature, Renewable energy

The "Global Vaporizers Market Report 2022, by Type, by Application, by Distribution Channel" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Vaporizers Market Report 2022, by Type, by Application, by Distribution Channel" report has been added to ResearchAndMarkets.com's offering.
  • The vaporizers market consists of sales of vaporizers.
  • The main types of vaporizers market are e-cigarette vaporizers, marijuana vaporizers, medical vaporizers.
  • Growing advancements in vaporizers are driving the growth of the vaporizers market.

Virtual Training Course: An Introduction to the Medical Device Regulation (November 8-10, 2022) - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 28, 2022
Education, Training, Health, Medical Devices, European Medical Writers Association, Pharmacovigilance, Medical device regulation, Notified body, CE, Documentation, Legislation, MDR, Medicine, Medical device

The "An Introduction to the Medical Device Regulation Training Course" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "An Introduction to the Medical Device Regulation Training Course" conference has been added to ResearchAndMarkets.com's offering.
  • This seminar provides an invaluable overview of the European Medical Device Regulation (MDR).
  • This event will be of particular interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector.
  • What is a medical device?