CE marking

Femasys Inc. EU MDR Final Audit Successfully Completed

Retrieved on: 
Thursday, October 26, 2023

ATLANTA, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today announced that it has successfully completed the Stage 2 European Union (EU) Medical Device Regulation (MDR 2017/745) onsite audit resulting in zero nonconformances and no findings.

Key Points: 
  • – Completion of the European Union Medical Device Regulation (MDR) final audit is the last step in obtaining an MDR certificate and CE marking, confirming Femasys’ compliance with the highest required regulatory standards –
    ATLANTA, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today announced that it has successfully completed the Stage 2 European Union (EU) Medical Device Regulation (MDR 2017/745) onsite audit resulting in zero nonconformances and no findings.
  • This is the final audit phase in the MDR designation process that was conducted by TUV SUD America Inc., a recognized Auditing Organization and Notified Body.
  • Successful completion of both Stage 1 and Stage 2 MDR audits confirms Femasys is compliant in all areas of MDR and may progress to issuance of the MDR certification, allowing for Femasys’ products to secure CE Marking.
  • “Femasys has worked diligently to implement the requirements of the EU MDR and completion of the final audit with zero nonconformances and no findings demonstrates Femasys has successfully met the new regulations and can soon supply our products to the European Union market,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys.

Edwards MITRIS RESILIA Valve Receives CE Mark for Mitral Replacement Surgeries

Retrieved on: 
Thursday, October 26, 2023

Edwards Lifesciences today announced it received CE Mark for the MITRIS RESILIA valve, a tissue valve replacement specifically designed for the heart's mitral position.

Key Points: 
  • Edwards Lifesciences today announced it received CE Mark for the MITRIS RESILIA valve, a tissue valve replacement specifically designed for the heart's mitral position.
  • The MITRIS RESILIA valve is made with innovative bovine pericardial tissue technology that reduces calcium build up on the valve.
  • View the full release here: https://www.businesswire.com/news/home/20231025088486/en/
    The MITRIS RESILIA valve is made with innovative tissue technology RESILIA allowing the valve to potentially last longer than conventional bioprosthetic valves.
  • * (Photo: Business Wire)
    The MITRIS RESILIA valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve.

BioLiNE® Technology a Global Leader in Advancing Science-Based Biostimulant Solutions Obtains CE Certification with Efficacy Claims

Retrieved on: 
Thursday, October 26, 2023

BioLiNE® Gold joins a small handful of biostimulant products that have received this certification.

Key Points: 
  • BioLiNE® Gold joins a small handful of biostimulant products that have received this certification.
  • These new regulations require efficacy data justifying the product claims for plant biostimulants.
  • The CE mark ensures growers that the biostimulants they are using are quality products, effective, and safe for the environment.
  • BioLiNE® Corp. is a Canadian technology development company that is focused on science-based solutions that improve the sustainability of food production.

Microbot Medical Received Confirmation for the Commencement of Its CE Mark Approval Process During the First Half of 2024

Retrieved on: 
Tuesday, October 24, 2023

BRAINTREE, Mass., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Robotic Surgical System, today announces it has received confirmation for the commencement of the process to support its future CE Mark approval, and to ultimately allow the Company to market the LIBERTY® Robotic Surgical System in Europe as well as other regions who accept the CE Mark.

Key Points: 
  • According to the confirmation, the Company will commence audits for ISO 13485 certification to ensure its compliance with the Quality Management System (QMS) requirements of the EU Medical Devices Regulation (MDR 2017/745), during the first half of 2024.
  • The Company had previously taken the first step to advance its European program by engaging with a leading Notified Body, who recently confirmed dates for conducting the required audits.
  • The audits for Microbot’s ISO 13485 certification will incorporate an off-site audit that includes a review of the Company’s quality system and the LIBERTY® Robotic Surgical System Technical File, followed by an on-site audit at the Company’s facilities.
  • “We intend that this process will be conducted in parallel with our FDA approval efforts, to allow us to capture as many markets across the globe as we prepare for future commercialization.”

Prostate Cancer Diagnosis Just Got Easier with CE Mark Certification of Lucida Medical's New AI Software

Retrieved on: 
Monday, October 23, 2023

CAMBRIDGE, United Kingdom, Oct. 23, 2023 /PRNewswire/ -- Lucida Medical Ltd, a Cambridge-based start-up company dedicated to improving cancer diagnosis, has announced Class IIb CE certification for its AI-based prostate cancer detection software, Prostate Intelligence™ (Pi™).

Key Points: 
  • CAMBRIDGE, United Kingdom, Oct. 23, 2023 /PRNewswire/ -- Lucida Medical Ltd, a Cambridge-based start-up company dedicated to improving cancer diagnosis, has announced Class IIb CE certification for its AI-based prostate cancer detection software, Prostate Intelligence™ (Pi™).
  • Built with leading clinicians and UK NHS hospitals, the CE mark means the software can now benefit patients across Europe.
  • Using AI, Pi™ analyses the MRI and is fully integrated into the radiologist's workflow, targeting key issues of variability, radiologist time, and diagnostic accuracy in prostate cancer.
  • As the most common cancer in men, each year, prostate cancer gains 1.4 million diagnoses and claims 375,000 lives.

STAAR Surgical Celebrates 30th Anniversary of Implantable Collamer® Lens (ICL)

Retrieved on: 
Tuesday, October 17, 2023

STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses for the eye, is celebrating the 30th anniversary of its proprietary Implantable Collamer® Lens (ICL).

Key Points: 
  • STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses for the eye, is celebrating the 30th anniversary of its proprietary Implantable Collamer® Lens (ICL).
  • The early ICLs have evolved into the current generation of ICLs with a central port – the EVO ICL™ family of lenses.
  • “We celebrate the 30th anniversary of our ICL technology with surgeons and patients,” said Tom Frinzi, President and CEO of STAAR Surgical.
  • 1 Packer M. The Implantable Collamer Lens with a central port: review of the literature.

NEXEN TIRE wins Good Design Award 2023 for Roadian HTX 2

Retrieved on: 
Thursday, October 12, 2023

SEOUL, South Korea, Oct. 12, 2023 (GLOBE NEWSWIRE) -- NEXEN TIRE, a leading global tire manufacturer, announced that it has been rewarded the Good Design Award (GDA) 2023 or G-Mark in Japan in the mobility category for its Roadian HTX 2 highway terrain tires.

Key Points: 
  • SEOUL, South Korea, Oct. 12, 2023 (GLOBE NEWSWIRE) -- NEXEN TIRE, a leading global tire manufacturer, announced that it has been rewarded the Good Design Award (GDA) 2023 or G-Mark in Japan in the mobility category for its Roadian HTX 2 highway terrain tires.
  • The Japan Institute of Design Promotion (JDP) sponsors the Good Design Award, which recognizes great design in a wide range of sectors, from industrial items to business strategies and event organization.
  • The Good Design Award recognizes and honors the essence of design, independent of its form, in an age where design is needed to solve issues and explore new ideas.
  • NEXEN TIRE’s Roadian HTX 2 is a highway terrain tire for SUV/LT with enhanced snow traction and mileage performance compared to its competitors.

Masimo ORi™ Granted De Novo as the First and Only FDA-Cleared Noninvasive and Continuous Parameter to Provide Insight into Hyperoxia Under Supplemental Oxygen

Retrieved on: 
Friday, October 13, 2023

Masimo (NASDAQ: MASI) today announced that ORi™, a noninvasive, continuous parameter designed to provide additional insight into a patient’s oxygen status in the moderate hyperoxic range under supplemental oxygen, has been granted a De Novo by the FDA.

Key Points: 
  • Masimo (NASDAQ: MASI) today announced that ORi™, a noninvasive, continuous parameter designed to provide additional insight into a patient’s oxygen status in the moderate hyperoxic range under supplemental oxygen, has been granted a De Novo by the FDA.
  • Enabled by the multi-wavelength Masimo rainbow® Pulse CO-Oximetry platform, ORi is designed for use in conjunction with oxygen saturation (SpO2) to provide increased resolution of changes in oxygenation under supplemental oxygen.
  • View the full release here: https://www.businesswire.com/news/home/20231013679815/en/
    Without ORi, there is no noninvasive way to monitor oxygenation under supplemental oxygen to manage hyperoxia, or higher than normal oxygenation of arterial blood.
  • By convention, SpO2 is limited to an upper limit of 100%, but oxygenation can rise into hyperoxia when supplemental oxygen is administered.

JenaValve Announces ALIGN-AR Pivotal Data to be Presented During the Late-Breaking Clinical Trial Sessions at TCT 2023

Retrieved on: 
Tuesday, September 19, 2023

The presentation will take place on Tuesday, October 24th, at 12:06 PM Pacific Time.

Key Points: 
  • The presentation will take place on Tuesday, October 24th, at 12:06 PM Pacific Time.
  • Prior to the data presentation, at 11:00 AM Pacific Time, a procedure using the CE Mark approved Trilogy THV System will be shown via broadcast from the University of Cologne.
  • Results from the study are intended to support a Premarket Approval submission to the U.S. Food and Drug Administration (FDA).
  • For additional information on the ALIGN-AR Trial or JenaValve, visit the JenaValve team at Booth #215 at TCT.

Realeve Unveils Breakthrough Solution to Treat Central Nervous System Disorders Including Stroke and Cluster Headache; Bypasses Brain’s Natural Barrier to Deliver Therapeutics

Retrieved on: 
Thursday, September 21, 2023

Realeve has also been granted Breakthrough Device designation from the FDA with a goal of obtaining FDA approval and CE Mark to treat cluster headaches in 2024.

Key Points: 
  • Realeve has also been granted Breakthrough Device designation from the FDA with a goal of obtaining FDA approval and CE Mark to treat cluster headaches in 2024.
  • We are also exploring its applications in other central nervous system disease conditions and excited about the potential,” states Dr. Peter Bonutti, founder and president, Realeve.
  • This technology holds promise for addressing conditions like Alzheimer's, tumors, and other central nervous system disorders.
  • The targeted therapy provides both pain relief, and can increase blood flow and medication delivery to the central nervous system.