CE marking

InspireMD Receives CE Mark Recertification Under EU’s New Medical Device Regulation (MDR) Regulatory Framework

Retrieved on: 
Wednesday, January 31, 2024

TEL AVIV, Israel and MIAMI, Jan. 31, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Carotid Stent System (EPS) for the prevention of stroke, today announced that it has received CE Mark recertification under the European Union’s new Medical Device Regulation (MDR) regulatory framework.

Key Points: 
  • TEL AVIV, Israel and MIAMI, Jan. 31, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Carotid Stent System (EPS) for the prevention of stroke, today announced that it has received CE Mark recertification under the European Union’s new Medical Device Regulation (MDR) regulatory framework.
  • MDR replaced the previous MDD framework, which had governed the approval and marketing of medical devices in the EU until May of 2021.
  • Marvin Slosman, chief executive officer of InspireMD, stated, “The transition from MDD to MDR has been challenging and has required us, and others in the medical device industry, to be comprehensive and persistent in our approach to addressing changes in requirements, timelines, and priorities during this process.
  • We continue to aggressively work toward multiple value creating milestones, including the potential U.S. approval of the CGuard Prime EPS stent system in the first half of 2025,” Mr. Slosman concluded.

Edwards’ EVOQUE Valve Replacement System First Transcatheter Therapy to Earn FDA Approval for Tricuspid Valve

Retrieved on: 
Friday, February 2, 2024

Edwards Lifesciences Corporation (NYSE: EW) today announced the company’s EVOQUE tricuspid valve replacement system is the first transcatheter therapy to receive U.S. Food and Drug Administration (FDA) approval for the treatment of tricuspid regurgitation (TR).

Key Points: 
  • Edwards Lifesciences Corporation (NYSE: EW) today announced the company’s EVOQUE tricuspid valve replacement system is the first transcatheter therapy to receive U.S. Food and Drug Administration (FDA) approval for the treatment of tricuspid regurgitation (TR).
  • The EVOQUE system is indicated for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy (OMT), for whom tricuspid valve replacement is deemed appropriate by a heart team.
  • “The EVOQUE system is able to replace the native tricuspid valve, virtually eliminating tricuspid regurgitation in a wide range of patients.
  • The EVOQUE system received CE Mark approval in October 2023, making it the world’s first transcatheter valve replacement therapy to receive regulatory approval to treat TR.

Boston Scientific Receives FDA Approval for FARAPULSE™ Pulsed Field Ablation System

Retrieved on: 
Wednesday, January 31, 2024

MARLBOROUGH, Mass., Jan. 31, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the FARAPULSE™ Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF) and is a unique new alternative to standard-of-care thermal ablation treatment.

Key Points: 
  • Strong clinical evidence base, largest volume of real-world use reinforce safety, efficacy and efficiency advantages of the system
    MARLBOROUGH, Mass., Jan. 31, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the FARAPULSE™ Pulsed Field Ablation (PFA) System.
  • "The approval of the FARAPULSE PFA System marks an important milestone for the millions of people living with paroxysmal AF and is an incredible opportunity to bring the first PFA system designed and built solely for this type of ablation therapy to physicians in the U.S.," said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific.
  • The FARAPULSE PFA System, however, relies on tissue-selective, non-thermal electric fields to ablate heart tissue and avoid damage to surrounding structures.
  • The company is developing a navigation-enabled version of the FARAWAVE catheter alongside the FARAVIEW™ Software Module and anticipates regulatory approval in 2024.

Cross-Border Impact Ventures Exceeds $90 Million in Final Close of Its Women’s and Children’s Health Technology Fund

Retrieved on: 
Thursday, January 25, 2024

The Fund also benefits from a guarantee provided by the Swedish International Development Cooperation Agency ( SIDA ).

Key Points: 
  • The Fund also benefits from a guarantee provided by the Swedish International Development Cooperation Agency ( SIDA ).
  • CBIV invests in health technology companies with global growth, high return, and impact potential.
  • Its primary focus is on medical device, diagnostic, and digital health companies based in North America and Europe that are globally relevant, including in emerging markets.
  • We bring in industry and clinical experts from our international network to unlock growth and impact,” said Donna Parr, Managing Partner at CBIV.

Element Science Receives CE Mark & UKCA Mark for the Jewel® Patch-Wearable Cardioverter Defibrillator

Retrieved on: 
Thursday, January 25, 2024

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240125437671/en/
    Element Science Receives CE Mark & UKCA Mark for the Jewel® Patch-Wearable Cardioverter Defibrillator First of its kind life-saving technology receives CE Mark and UKCA Mark, paving the way for enhanced protection of patients with elevated risk of sudden cardiac arrest.
  • (Photo: Business Wire)
    The Jewel P-WCD was designed to address limitations with traditional garment-based WCDs.
  • The company is now well positioned to plan for delivering this lifesaving technology to patients outside the US."
  • The Jewel P-WCD is limited to investigational use only and is not available for sale in the United States.

Clarius Receives CE Mark Certification for its Dual-Array Wireless Handheld Scanner for Whole-Body Ultrasound Imaging

Retrieved on: 
Wednesday, January 17, 2024

Clarius Mobile Health , a global leader in wireless ultrasound solutions, has received CE Mark for its revolutionary Clarius PAL HD3 wireless handheld whole-body ultrasound scanner combining phased and linear arrays on a single head.

Key Points: 
  • Clarius Mobile Health , a global leader in wireless ultrasound solutions, has received CE Mark for its revolutionary Clarius PAL HD3 wireless handheld whole-body ultrasound scanner combining phased and linear arrays on a single head.
  • The Clarius PAL HD3 high-definition wireless scanner is available today in Europe and the United Kingdom .
  • View the full release here: https://www.businesswire.com/news/home/20240117813694/en/
    New Clarius PAL HD3 wireless handheld whole-body ultrasound scanner uniquely combines phased and linear arrays on a single head.
  • Clarius PAL HD3 is the 11th wireless handheld ultrasound scanner in the Clarius specialty ultrasound lineup.

Reflow Medical Receives CE Mark for Bare Temporary Spur Stent System for Treating de novo or Restenotic Below-the-Knee (BTK) Lesions

Retrieved on: 
Tuesday, January 16, 2024

Reflow Medical, Inc., a developer of innovative medical devices focused on cardiovascular disease, announces it has received CE (Conformité Européenne) Mark certification in the European Union for the Bare Temporary Spur Stent System .

Key Points: 
  • Reflow Medical, Inc., a developer of innovative medical devices focused on cardiovascular disease, announces it has received CE (Conformité Européenne) Mark certification in the European Union for the Bare Temporary Spur Stent System .
  • The device is intended to treat de novo or restenotic lesions in the infrapopliteal arteries with a commercially available drug-coated balloon (DCB) to enhance drug absorption.
  • View the full release here: https://www.businesswire.com/news/home/20240116803175/en/
    The Bare Temporary Spur Stent System is a unique clinical solution known as Retrievable Stent Therapy, or RST.
  • The Bare Temporary Spur Stent System is a unique clinical solution intended to provide stent-like results while leaving no metal behind.

FDA approves Medtronic Percept™ RC neurostimulator with exclusive BrainSense™ technology

Retrieved on: 
Monday, January 8, 2024

DUBLIN, Jan. 8, 2024 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced the U.S. Food and Drug Administration (FDA) approval of its Percept™ RC Deep Brain Stimulation (DBS) system. The rechargeable neurostimulator is the latest innovation in the Medtronic Percept™ family, which includes the Percept™ PC neurostimulator, BrainSense™ technology†, and SenSight™ directional leads. The Percept™ family is the only sensing-enabled DBS system on the market, allowing the physician to personalize treatment for patients with movement disorders such as Parkinson's disease, essential tremor, and dystonia* as well as epilepsy. Over 11 million people in the U.S. are living with movement disorders1-2 and approximately 3.4 million with epilepsy3.

Key Points: 
  • DUBLIN, Jan. 8, 2024 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced the U.S. Food and Drug Administration (FDA) approval of its Percept™ RC Deep Brain Stimulation (DBS) system.
  • The rechargeable neurostimulator is the latest innovation in the Medtronic Percept™ family, which includes the Percept™ PC neurostimulator, BrainSense™ technology†, and SenSight™ directional leads.
  • Percept™ RC is available immediately throughout the U.S., as well as via CE Mark approval in Europe and availability in Japan.
  • For further information on the Percept™ neurostimulators with exclusive BrainSense™ technology, visit our website here .

Stereotaxis Announces First Patients Successfully Treated Using MAGiC Ablation Catheter

Retrieved on: 
Monday, January 8, 2024

ST. LOUIS, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announced that the first patients have been successfully treated using its Magnetic Interventional Ablation Catheter, MAGiC™.

Key Points: 
  • ST. LOUIS, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announced that the first patients have been successfully treated using its Magnetic Interventional Ablation Catheter, MAGiC™.
  • Stereotaxis’ MAGiC catheter is a robotically navigated magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures.
  • The first human procedures using the MAGiC catheter were successfully performed by Prof. Germanas Marinskis and Assoc.
  • “We were delighted to perform the first procedures using the MAGiC catheter, and were pleased with the performance,” said.

Cerus Corporation Announces Preliminary Fourth Quarter and Full-Year 2023 Product Revenue and Provides Business Update

Retrieved on: 
Monday, January 8, 2024

Cerus Corporation (Nasdaq: CERS) today announced preliminary product revenue for the fourth quarter and full-year 2023 and provided product revenue guidance for full-year 2024.

Key Points: 
  • Cerus Corporation (Nasdaq: CERS) today announced preliminary product revenue for the fourth quarter and full-year 2023 and provided product revenue guidance for full-year 2024.
  • Cerus’ unaudited preliminary product revenue for the fourth quarter of 2023 totaled $46.8 million, representing an increase of 6% over the $44.0 million recognized during the fourth quarter of 2022 and 18% sequentially.
  • The Company expects its unaudited preliminary full-year 2023 product revenue to be $156.4 million, in line with the Company’s 2023 product revenue guidance range of $155-$158 million.
  • “Additionally, we continue to expect to realize adjusted EBITDA breakeven for the fourth quarter 2023 when we report complete fourth quarter 2023 and year-end results,” continued Greenman.