Medical device regulation

Neuronetics Receives MDSAP Certification and CE Mark Certification under New MDR

Retrieved on: 
Monday, May 8, 2023

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: 
Thursday, April 27, 2023

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: 
Thursday, April 27, 2023

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: 
Sunday, April 23, 2023

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.

Celluma Light Therapy Receives EU-MDR Certification

Retrieved on: 
Tuesday, April 4, 2023

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

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.

BeVinced launches MedTech CRO services

Retrieved on: 
Tuesday, March 28, 2023

AMSTERDAM, March 28, 2023 /PRNewswire/ -- BeVinced, a new leading Clinical Research Organization (CRO) specializing in Medical Device Regulation (MDR) compliance services, is proud to announce the launch of its services aimed at addressing the unique needs of the medical device industry.

Key Points: 
  • AMSTERDAM, March 28, 2023 /PRNewswire/ -- BeVinced, a new leading Clinical Research Organization (CRO) specializing in Medical Device Regulation (MDR) compliance services, is proud to announce the launch of its services aimed at addressing the unique needs of the medical device industry.
  • The company was started by two recognized experts in the MedTech CRO arena: Joris Bannenberg and Dirk Meijer, both MD.
  • "We are thrilled to launch our niche CRO services for the MedTech industry.
  • For more information about BeVinced and our niche CRO services for the MedTech industry, please visit our website at www.bevinced.com .

BeVinced launches MedTech CRO services

Retrieved on: 
Tuesday, March 28, 2023

AMSTERDAM, March 28, 2023 /PRNewswire/ -- BeVinced, a new leading Clinical Research Organization (CRO) specializing in Medical Device Regulation (MDR) compliance services, is proud to announce the launch of its services aimed at addressing the unique needs of the medical device industry.

Key Points: 
  • AMSTERDAM, March 28, 2023 /PRNewswire/ -- BeVinced, a new leading Clinical Research Organization (CRO) specializing in Medical Device Regulation (MDR) compliance services, is proud to announce the launch of its services aimed at addressing the unique needs of the medical device industry.
  • The company was started by two recognized experts in the MedTech CRO arena: Joris Bannenberg and Dirk Meijer, both MD.
  • "We are thrilled to launch our niche CRO services for the MedTech industry.
  • For more information about BeVinced and our niche CRO services for the MedTech industry, please visit our website at www.bevinced.com .

EQS-News: Marinomed Biotech AG reports positive clinical data for the Carragelose decongestant nasal spray

Retrieved on: 
Thursday, March 16, 2023

Korneuburg, Austria, 14 March 2023 – Marinomed Biotech AG, listed on the Vienna Stock Exchange (VSE:MARI), today announced positive results from its clinical study on the decongestant effect of the Sorbitol-containing Carragelose nasal spray.

Key Points: 
  • Korneuburg, Austria, 14 March 2023 – Marinomed Biotech AG, listed on the Vienna Stock Exchange (VSE:MARI), today announced positive results from its clinical study on the decongestant effect of the Sorbitol-containing Carragelose nasal spray.
  • While Carragelose was shown to be an effective treatment of viral infections of the respiratory tract, Sorbitol exerts a decongestant effect.
  • The Carragelose and Sorbitol nasal spray was launched in 2018 and is currently marketed in 11 countries as a common cold product.
  • Based on the current clinical results, Marinomed plans to expand both the applications and target markets for the decongestant nasal spray.

Sunrise Raises €17 Million and Aims to Increase Its Size Tenfold Within 5 Years

Retrieved on: 
Thursday, March 9, 2023

The successful fundraising is led by Kurma Partners and includes the exceptional entry of the European Innovation Council (EIC Fund).

Key Points: 
  • The successful fundraising is led by Kurma Partners and includes the exceptional entry of the European Innovation Council (EIC Fund).
  • Sunrise hopes to make a real difference to the lives of millions of people around the world who suffer from sleep disorders.
  • Sunrise is proud to announce a €17 million financing round.
  • Sunrise aims to multiply the size of its teams by 10 in the next 5 years.