CE marking

InspireMD Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, March 6, 2024

TEL AVIV, Israel and MIAMI, March 06, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced financial and operating results for the fourth quarter and full-year ended December 31, 2023.

Key Points: 
  • Fourth Quarter 2023 and Recent Developments:
    Generated record CGuard revenue in the fourth quarter 2023 of $1.76 million, a 71.6% increase over the fourth quarter of 2022.
  • Sold 3,107 CGuard EPS stent systems in the fourth quarter of 2023, as compared to 1,781 in the fourth quarter of 2022, an increase of 74.5%.
  • Financial Results for the Fourth Quarter Ended December 31, 2023
    For the fourth quarter of 2023, total revenue increased 71.6%, to $1,761,000, from $1,026,000 during the fourth quarter of 2022.
  • Total financial income for the fourth quarter of 2023 was $468,000, an increase of $349,000 or 293% compared to $119,000 for the third quarter of 2022.

Stereotaxis Announces Regulatory Submissions of the MAGiC Ablation Catheter in Europe and the United States

Retrieved on: 
Monday, March 4, 2024

ST. LOUIS, March 04, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that regulatory submissions were made recently in both Europe and the United States for the MAGiC™ catheter.

Key Points: 
  • ST. LOUIS, March 04, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that regulatory submissions were made recently in both Europe and the United States for the MAGiC™ catheter.
  • Stereotaxis’ MAGiC catheter is a robotically navigated magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures.
  • The first human procedures with the MAGiC catheter commenced earlier this year as part of a prospective multi-center clinical study.
  • Stereotaxis anticipates making the MAGiC catheter commercially available for the community of robotic electrophysiologists following receipt of regulatory clearances.

Venus Concept Announces CE Mark for Venus Versa Pro in Europe

Retrieved on: 
Thursday, February 22, 2024

TORONTO, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), a global medical aesthetic technology leader, today announced that it has received the CE Mark from DEKRA Certification B.V. to market the Venus Versa Pro system in the European Union.

Key Points: 
  • TORONTO, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), a global medical aesthetic technology leader, today announced that it has received the CE Mark from DEKRA Certification B.V. to market the Venus Versa Pro system in the European Union.
  • The Venus Versa Pro incorporates Venus Concept’s latest advancements in fractional skin resurfacing, enabling enhanced ablation and coagulation to achieve optimal results when treating a wide range of skin conditions including acne scars, skin texture, and stretch marks.
  • “Receiving the CE Mark for Venus Versa Pro reflects our continued commitment to bringing our latest and most innovative products to the international aesthetic markets in parallel with our restructuring efforts,” said Dr. Hemanth Varghese, President and Chief Operating Officer of Venus Concept.
  • “Venus Versa Pro builds on the successful Venus Versa system, with over 2,200 systems installed globally.

EG Bio Announces CE Mark Approval for EDEL X™ HA Dermal Filler in the European Market

Retrieved on: 
Monday, February 26, 2024

SEOUL, South Korea, Feb. 26, 2024 /PRNewswire-PRWeb/ -- EG Bio Co., LTD, a trailblazer in the aesthetic industry, is thrilled to announce that it has obtained CE Mark certification for its innovative product, the EDEL X™ HA Dermal Filler, making it available for the European market. This milestone underscores EG Bio Co., LTD's commitment to providing safe, high-quality aesthetic solutions on a global scale.

Key Points: 
  • SEOUL, South Korea, Feb. 26, 2024 /PRNewswire-PRWeb/ -- EG Bio Co., LTD , a trailblazer in the aesthetic industry, is thrilled to announce that it has obtained CE Mark certification for its innovative product, the EDEL X™ HA Dermal Filler, making it available for the European market.
  • This milestone underscores EG Bio Co., LTD's commitment to providing safe, high-quality aesthetic solutions on a global scale.
  • EDEL X™ is a state-of-the-art hyaluronic acid (HA) dermal filler enhanced with lidocaine, designed for safe and comfortable injections.
  • The introduction of EDEL X™ HA Dermal Filler with Lidocaine marks a new epoch in cosmetic enhancements and helps reduce the appearance of lines and wrinkles.

ScreenPoint Medical Showcases Transpara® Breast AI Designed to Improve Cancer Detection and Support Single Reader Screening at ECR

Retrieved on: 
Wednesday, February 21, 2024

VIENNA, Feb. 21, 2024 /PRNewswire/ -- ScreenPoint Medical is showcasing its industry leading Transpara Breast AI at the 2024 European Congress of Radiology (ECR) meeting, February 28-March 3, 2024 (Booth #AI-31 in Expo Hall X1). Transpara provides radiologists with a 'second pair' of eyes to help detect cancers earlier and reduce recall rates.

Key Points: 
  • Transpara continues to deliver proven clinical and workflow benefits in mammography screening in global practice and clinical research.
  • AI-supported screening resulted in significant and substantial improvements compared to double reading without AI.
  • This presentation can be seen is: "Is it worth reading low-risk breast cancer screening mammograms as determined by an artificial intelligence (AI) system?
  • An informed review of 120 interval cancer cases with high AI scores in breast screen Norway (RPS-2405, ACV Research Stage 1, March 3, 11.30am).

ScreenPoint Medical Showcases Transpara® Breast AI Designed to Improve Cancer Detection and Support Single Reader Screening at ECR

Retrieved on: 
Wednesday, February 21, 2024

VIENNA, Feb. 21, 2024 /PRNewswire/ -- ScreenPoint Medical is showcasing its industry leading Transpara Breast AI at the 2024 European Congress of Radiology (ECR) meeting, February 28-March 3, 2024 (Booth #AI-31 in Expo Hall X1). Transpara provides radiologists with a 'second pair' of eyes to help detect cancers earlier and reduce recall rates.

Key Points: 
  • Transpara continues to deliver proven clinical and workflow benefits in mammography screening in global practice and clinical research.
  • AI-supported screening resulted in significant and substantial improvements compared to double reading without AI.
  • This presentation can be seen is: "Is it worth reading low-risk breast cancer screening mammograms as determined by an artificial intelligence (AI) system?
  • An informed review of 120 interval cancer cases with high AI scores in breast screen Norway (RPS-2405, ACV Research Stage 1, March 3, 11.30am).

Sight Sciences Announces European Launch of the Ergo-Series of the OMNI® Surgical System at the ESCRS Winter Meeting

Retrieved on: 
Wednesday, February 14, 2024

"We believe the improved handle ergonomics, simplified viscoelastic preparation, and new cannula tip design will be invaluable to our European partners, so we are excited to launch the technology at the European Society of Cataract and Refractive Surgeons (“ESCRS”) Winter meeting this week in Frankfurt."

Key Points: 
  • "We believe the improved handle ergonomics, simplified viscoelastic preparation, and new cannula tip design will be invaluable to our European partners, so we are excited to launch the technology at the European Society of Cataract and Refractive Surgeons (“ESCRS”) Winter meeting this week in Frankfurt."
  • “The innovations in design of the Ergo-Series have the benefit of making the device even more intuitive to hold and operate.
  • The enhanced cannula tip can provide gentle, precise access to Schlemm’s canal and improved tactile feedback, giving the surgeon confidence at every step of the procedure.
  • I believe these improvements make OMNI even more accessible for surgeons treating all stages of open-angle glaucoma.”

MIVI Neuroscience™ Presents Primary Endpoint Results from the EvaQ Trial — at the 2024 International Stroke Conference

Retrieved on: 
Thursday, February 8, 2024

MIVI Neuroscience, Inc. (Eden Prairie, MN) announces the primary endpoint results of its EvaQ Trial, a prospective, multi-center, global, single arm, FDA-regulated IDE trial study to evaluate the safety and effectiveness of the MIVI Q™ Revascularization System for treating acute ischemic stroke.

Key Points: 
  • MIVI Neuroscience, Inc. (Eden Prairie, MN) announces the primary endpoint results of its EvaQ Trial, a prospective, multi-center, global, single arm, FDA-regulated IDE trial study to evaluate the safety and effectiveness of the MIVI Q™ Revascularization System for treating acute ischemic stroke.
  • The data were presented yesterday at the 2024 International Stroke Conference (AZ), a premier event featuring global thought leaders and dedicated to the latest in the science and treatment of cerebrovascular disease and brain health.
  • Results of the EvaQ Trial show the Q Revascularization System to be safe and effective for thrombectomy of Large Vessel Occlusion (LVO) strokes.
  • The primary safety endpoint was symptomatic intracranial hemorrhage (sICH) which was observed at a rate of 6.5%.

Corista DP3® Platform Receives Class II Medical Device License From Health Canada

Retrieved on: 
Wednesday, February 7, 2024

CONCORD, Mass., Feb. 7, 2024 /PRNewswire-PRWeb/ -- Corista, a leader in digital pathology solutions, is excited to announce that it has received a Class II Medical Device License from Health Canada for its DP3 platform.

Key Points: 
  • CONCORD, Mass., Feb. 7, 2024 /PRNewswire-PRWeb/ -- Corista, a leader in digital pathology solutions, is excited to announce that it has received a Class II Medical Device License from Health Canada for its DP3 platform.
  • Attaining the Class II Medical Device License from Canada is an important milestone in making this possible," says Corista CEO and Co-Founder Elizabeth Wingard.
  • The Class II Medical Device License further supports Corista's recently announced strategic partnership with AGFA HealthCare, providing a digital pathology workflow solution to its Canadian customer base.
  • "Attaining the Class II Medical Device License from Canada is an important milestone in making this possible.

Edwards Lifesciences Reports Fourth Quarter Results

Retrieved on: 
Tuesday, February 6, 2024

Edwards Lifesciences (NYSE: EW) today reported financial results for the quarter ended December 31, 2023.

Key Points: 
  • Edwards Lifesciences (NYSE: EW) today reported financial results for the quarter ended December 31, 2023.
  • In the fourth quarter, Edwards remained focused on its key value drivers to unlock the significant long-term opportunity for patients: a portfolio of differentiated therapies; positive clinical trial results to support approvals and adoption; and favorable real-world clinical outcomes.
  • Research and development expenses in the fourth quarter grew 16 percent over the prior year to $270 million, or 17.6 percent of sales.
  • During the fourth quarter, the company repurchased $444 million of stock through a combination of a pre-established trading plan and accelerated share repurchase programs.