CE marking

Motus GI Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 13, 2023
Ministry, Food, MDR, Mortality, CE marking, Research, FDA, Hematochezia, R, Gastroenterology, Medical device, Retail, Health

“The past several months was an exciting period for the Company, as we executed against our strategy on several fronts.

Key Points: 
  • “The past several months was an exciting period for the Company, as we executed against our strategy on several fronts.
  • Financial Results for the Third Quarter Ended September 30, 2023
    The Company reported revenue of $86,000 for the third quarter 2023, compared to $278,000 for the same period last year.
  • Share data is on a split adjusted basis resulting from the Company’s reverse stock split effective as of November 2, 2023.
  • This balance included the fully funded credit facility with Kreos Capital, which has approximately $9.2 million due and outstanding as of September 30, 2023.

Edwards Lifesciences Outlines Growth Strategy at Annual Investor Conference

Retrieved on: 
Thursday, December 7, 2023
General Health, Health, Cardiology, TAVR, Corporation, NYSE, Tricuspid valve, Investment, Surgery, Percutaneous aortic valve replacement, Patient, CE marking, PASCAL, PROGRESS, Conference, CLASP, Aortic stenosis, Growth, Development, TCT, Edwards Lifesciences, Critical care, Pharmaceutical industry, Nursing, Pet industry, Management

Edwards Lifesciences Corporation (NYSE: EW) will discuss the company’s sharpened focus and strategy for longer-term growth, provide an update on its technology pipeline and share financial guidance1 today during its annual investor conference.

Key Points: 
  • Edwards Lifesciences Corporation (NYSE: EW) will discuss the company’s sharpened focus and strategy for longer-term growth, provide an update on its technology pipeline and share financial guidance1 today during its annual investor conference.
  • Continued progress across these areas will result in more patients diagnosed and treated with Edwards’ repair and replacement technologies, and a significant long-term growth opportunity.
  • Also in 2024, Edwards expects to accelerate its surgical mitral leadership with the global commercialization of its MITRIS RESILIA valve.
  • During the conference, Edwards’ management will reaffirm the company’s 2023 financial guidance and provide guidance for 2024.

BioStar Capital Closes Fund V at $130.3 Million, Surpassing Previous Funds

Retrieved on: 
Wednesday, December 6, 2023
Technology, Medical Devices, Finance, Health Technology, Professional Services, Cardiology, Health, Robotics, General Health, Artery, Tricuspid valve, Investment, Disease, Elective surgery, MMI, Cardiovascular disease, CE marking, Biostar, Instrument, AVS, Cleveland Clinic, Optimism, Pharmaceutical industry

BioStar Capital , a strategic venture capital firm focusing on transformative medical technologies primarily in the fields of cardiovascular disease, orthopedics, and robotics, has announced it has closed its fifth fund at $130.3 million, more than its three previous funds combined.

Key Points: 
  • BioStar Capital , a strategic venture capital firm focusing on transformative medical technologies primarily in the fields of cardiovascular disease, orthopedics, and robotics, has announced it has closed its fifth fund at $130.3 million, more than its three previous funds combined.
  • BioStar expects to invest in 8-10 additional companies over the next five years.
  • In a time of declining investments in venture capital, BioStar’s closing overcame current environmental challenges, demonstrating investor confidence in the firm’s unique model leveraging physician, as well as financial and operational expertise in today’s dynamic healthcare environment.
  • While other venture capital firms are shifting their focus to areas such as cardiovascular medical devices, few have the decades of experience and clinical expertise that BioStar offers through its team of Medical Venture Partners (“MVPs”) and network of physician investors.

Corista's DP3® Image Management System for Digital Pathology Earns CE Mark Under IVDR for Routine Pathology Diagnosis

Retrieved on: 
Thursday, December 14, 2023
Gross metropolitan product, European Economic Area, Pathology, AGFA, European, CE marking, CE, Diagnosis, Partnership, IVDR, Certification, EEA

CONCORD, Mass., Dec. 14, 2023 /PRNewswire-PRWeb/ -- Corista, a leader in digital pathology solutions, announced its DP3 platform has been certified with the CE In Vitro Diagnostic (IVDR) marking, for routine diagnosis in the European Union and United Kingdom. The CE mark, or Conformité Européenne, is a mandatory regulatory standard that verifies that products are safe to use in the European Economic Area (EEA). The mark indicates that a product complies with European safety rules and can be traded freely within the EEA.

Key Points: 
  • The CE mark, or Conformité Européenne, is a mandatory regulatory standard that verifies that products are safe to use in the European Economic Area (EEA).
  • The mark indicates that a product complies with European safety rules and can be traded freely within the EEA.
  • "For nearly two decades we've been driving the advancement of clinical health system management and the integration of digital pathology into laboratory information systems.
  • To learn more about Corista and the DP3 Image Management System for digital pathology, please visit www.corista.com .

Inovedis Announces First Patients Treated with the SINEFIX™ Rotator Cuff Repair System

Retrieved on: 
Wednesday, December 13, 2023
Safety, Suture, Food, Entrepreneurship, Patient, CE marking, FDA, Strangling, System, Bruise, Doctor of Philosophy, Health, Medical device, Pharmaceutical industry, Medical imaging, Invention, MD

ALBSTADT, Germany, Dec. 13, 2023 /PRNewswire/ -- Inovedis GmbH, a medical technology start-up dedicated to offering innovative solutions that contribute both to optimized patient care as well as minimizing the complexity of surgical interventions, today announced that the first two patients were treated with the SINEFIX™ Rotator Cuff Repair System as part of a pre-market clinical study in Tübingen, Germany.

Key Points: 
  • "I believe that SINEFIX has favorable biomechanics and will result in optimal tendon cell growth back to the bone.
  • These first clinical cases will help assess the usability and efficacy of the implant while building our clinical experience."
  • "Suture anchor technology, the current clinical gold standard for rotator cuff repair surgery, has been used for decades and has been continuously optimized and diversified.
  • Lukas Flöss, Co-Founder and Chief Executive Officer of Inovedis, said, "Successfully beginning the treatment of patients with the SINEFIX implant is a tremendous milestone, both for our company and rotator cuff patients globally.

Partnership Between ARUP and Medicover Expands Access to Companion Diagnostic in the European Union

Retrieved on: 
Wednesday, December 6, 2023
ARUP Laboratories, Safety, Haemophilia, European Medicines Agency, CDX, Plasma, CE marking, Laboratory, EMA, Patient, Medicine, European, FDA, ARUP, BioMarin Pharmaceutical, MBA, MD, Partnership, Clinical trial, Antibody, Haemophilia A, IVDR, Injury, Health, Sodium, Medical device, Vaccine, Pharmaceutical industry, Medicover Hospitals

SALT LAKE CITY, Dec. 6, 2023 /PRNewswire/ -- A partnership between ARUP Laboratories and Medicover has made a new companion diagnostic, and thereby a new gene therapy, more accessible to patients in the European Union.

Key Points: 
  • SALT LAKE CITY, Dec. 6, 2023 /PRNewswire/ -- A partnership between ARUP Laboratories and Medicover has made a new companion diagnostic, and thereby a new gene therapy, more accessible to patients in the European Union.
  • "Our ultimate goal, in partnership with BioMarin, is to make AAV5 DetectCDx™ available in all markets where ROCTAVIAN will be authorized so that patients have access to this revolutionary treatment."
  • The approval of the AAV5 DetectCDx™ Kit is the result of a close collaboration between ARUP, Medicover, and BioMarin.
  • "Our PharmaDx group exists to support companion diagnostic testing for the development of cutting-edge therapies in diseases with significant unmet clinical need.

Isothermal Nucleic Acid Amplification Technology Market worth $8.83 Bn by 2031 - Exclusive Report by InsightAce Analytic Pvt. Ltd.

Retrieved on: 
Friday, November 24, 2023
Preventive healthcare, ID, Conditional sentence, Prevalence, CMV, Viral load, US Foods, Coronavirus, Patient, Gynaecology, CE marking, NAT, FDA, Genetic testing, COVID-19, Emergency Use Authorization, CMS, Food and Drug Administration, Cancer, Cytomegalovirus, Medicare, Medicare Payment Advisory Commission, Obstetrics, Malaria, History of Stanford Medicine, Vaccine, Pharmaceutical industry, Grifols

Grifols (Spain), for example, received the CE Mark in June 2022 for the Procleix Plasmodium Assay, a nucleic acid test (NAT) specifically approved for screening blood donors for malaria.

Key Points: 
  • Grifols (Spain), for example, received the CE Mark in June 2022 for the Procleix Plasmodium Assay, a nucleic acid test (NAT) specifically approved for screening blood donors for malaria.
  • Hologic, Inc. (US) got US Food and Drug Administration (FDA) approval for the Aptima CMV Quant Assay in May 2022.
  • The viral load of cytomegalovirus (CMV) will be quantified in patients who have received an organ or stem cell transplant.
  • Since of the region's high prevalence of chronic diseases, technological advancement in isothermal nucleic acid amplification technology (INAAT), and increasing adoption of INAAT over conventional techniques, North America dominates the Isothermal Nucleic Acid Amplification Technology (INAAT) market.

Isothermal Nucleic Acid Amplification Technology Market worth $8.83 Bn by 2031 - Exclusive Report by InsightAce Analytic Pvt. Ltd.

Retrieved on: 
Friday, November 24, 2023
Preventive healthcare, ID, Conditional sentence, Prevalence, CMV, Viral load, US Foods, Coronavirus, Patient, Gynaecology, CE marking, NAT, FDA, Genetic testing, COVID-19, Emergency Use Authorization, CMS, Food and Drug Administration, Cancer, Cytomegalovirus, Medicare, Medicare Payment Advisory Commission, Obstetrics, Malaria, History of Stanford Medicine, Vaccine, Pharmaceutical industry, Grifols

Grifols (Spain), for example, received the CE Mark in June 2022 for the Procleix Plasmodium Assay, a nucleic acid test (NAT) specifically approved for screening blood donors for malaria.

Key Points: 
  • Grifols (Spain), for example, received the CE Mark in June 2022 for the Procleix Plasmodium Assay, a nucleic acid test (NAT) specifically approved for screening blood donors for malaria.
  • Hologic, Inc. (US) got US Food and Drug Administration (FDA) approval for the Aptima CMV Quant Assay in May 2022.
  • The viral load of cytomegalovirus (CMV) will be quantified in patients who have received an organ or stem cell transplant.
  • Since of the region's high prevalence of chronic diseases, technological advancement in isothermal nucleic acid amplification technology (INAAT), and increasing adoption of INAAT over conventional techniques, North America dominates the Isothermal Nucleic Acid Amplification Technology (INAAT) market.

ScreenPoint Medical Hits New Milestones

Retrieved on: 
Tuesday, November 21, 2023
Breast, RSNA, Research, Lauritzen, Patient, Mammography, CE marking, FDA, Workflow, 2D, 3D, Cancer, Workload, Radiology, AI, Medical device, Medical imaging

NIJMEGEN, Netherlands, Nov. 21, 2023 /PRNewswire/ -- ScreenPoint Medical, announced that its TransparaR breast AI has surpassed 5 million mammograms, including over 1 Million Tomosynthesis (3D) exams analyzed in support of radiologists reading mammography exams. Transpara provides radiologists with a 'second pair' of eyes helping detect cancers earlier and reduce recall rates. 

Key Points: 
  • Transpara provides radiologists with a 'second pair' of eyes helping detect cancers earlier and reduce recall rates.
  • ScreenPoint will showcase its industry leading Transpara results at the upcoming 109th Annual Radiological Society of North America (RSNA) meeting, November 26-30, 2023 (South Hall #3947).
  • Our in-development offerings will continue to expand the reach and impact of Transpara Portfolio in helping radiologists detect cancer earlier and safely reduce workload," said Mark Koeniguer, ScreenPoint Medical CEO.
  • Research shows that up to 45% of interval cancers can be found earlier using Transpara, while helping to reduce workload and optimize workflow.

ScreenPoint Medical Hits New Milestones

Retrieved on: 
Tuesday, November 21, 2023
Breast, RSNA, Research, Lauritzen, Patient, Mammography, CE marking, FDA, Workflow, 2D, 3D, Cancer, Workload, Radiology, AI, Medical device, Medical imaging

NIJMEGEN, Netherlands, Nov. 21, 2023 /PRNewswire/ -- ScreenPoint Medical, announced that its TransparaR breast AI has surpassed 5 million mammograms, including over 1 Million Tomosynthesis (3D) exams analyzed in support of radiologists reading mammography exams. Transpara provides radiologists with a 'second pair' of eyes helping detect cancers earlier and reduce recall rates. 

Key Points: 
  • Transpara provides radiologists with a 'second pair' of eyes helping detect cancers earlier and reduce recall rates.
  • ScreenPoint will showcase its industry leading Transpara results at the upcoming 109th Annual Radiological Society of North America (RSNA) meeting, November 26-30, 2023 (South Hall #3947).
  • Our in-development offerings will continue to expand the reach and impact of Transpara Portfolio in helping radiologists detect cancer earlier and safely reduce workload," said Mark Koeniguer, ScreenPoint Medical CEO.
  • Research shows that up to 45% of interval cancers can be found earlier using Transpara, while helping to reduce workload and optimize workflow.