CE marking

Lunit Becomes the First Medical Software Company in Asia-Pacific to Become MDR CE and UKCA Certified

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Monday, November 21, 2022
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The Lunit INSIGHT product line also received the UK Conformity Assessed (UKCA) marking, obtaining commercial approval across both the UK and Europe.

Key Points: 
  • The Lunit INSIGHT product line also received the UK Conformity Assessed (UKCA) marking, obtaining commercial approval across both the UK and Europe.
  • With these two markings, Lunit has become the first software as a medical device (SaMD) company in the Asia Pacific region to earn such accreditation.
  • Among the Lunit INSIGHT suite, two products received the MDR CE and UKCA certifications: Lunit INSIGHT CXR, an AI solution for chest x-ray analysis, and Lunit INSIGHT MMG, an AI solution for mammography analysis.
  • "Our MDR CE and UKCA certifications clearly show Lunit's high product power and advanced regulatory compliance capabilities," remarked Brandon Suh, CEO of Lunit.

THORNE HEALTHTECH'S ONEDRAW DEVICE USED IN DEPARTMENT OF DEFENSE'S CANCER MOONSHOT 2.0 PROJECT, PROMETHEUS, AS PART OF PRESIDENT BIDEN INITIATIVE

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Thursday, November 17, 2022
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"As health and wellness continues to evolve and demands for reliable and convenient testing grow, our OneDraw device showcases that next-gen multi-omics testing can be performed on patient-friendly platforms," said Paul Jacobson, CEO of Thorne HealthTech.

Key Points: 
  • "As health and wellness continues to evolve and demands for reliable and convenient testing grow, our OneDraw device showcases that next-gen multi-omics testing can be performed on patient-friendly platforms," said Paul Jacobson, CEO of Thorne HealthTech.
  • "At Thorne HealthTech, we believe in the power of scientific wellness and taking a preventative approach to health and wellness, which is exactly what President Biden's Cancer Moonshot Project is doing with our OneDraw device."
  • This research is critical to developing new tools for the early detection and possible prevention of cancer."
  • Arising out of President Biden's White House Cancer Moonshot 2.0 initiative in 2022, PROMETHEUS is a project of the Department of Defense's Uniformed Services University of the Health Sciences (USU) Murtha Cancer Center Research Program (MCCRP).

Lunit to Supply AI Platform to Australia's BreastScreen NSW Machine Reading Project

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Wednesday, November 16, 2022
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In 2021, the Cancer Institute NSW sought proposals and test results from potential suppliers for the supply, fulfillment, and/or delivery of a world-leading BreastScreen Machine Reading Solution built on the latest generation of deep machine learning AI technology for detecting cancers in screening mammograms.

Key Points: 
  • In 2021, the Cancer Institute NSW sought proposals and test results from potential suppliers for the supply, fulfillment, and/or delivery of a world-leading BreastScreen Machine Reading Solution built on the latest generation of deep machine learning AI technology for detecting cancers in screening mammograms.
  • Lunit INSIGHT MMGan AI solution for mammography analysiswas named as the preferred solution for this project.
  • Phase 1 of the BSNSW Machine Reading Project will validate the Lunit INSIGHT MMG solution to confirm the potential clinical benefits prior to operational deployment.
  • In this final phase, additional evaluations will be conducted to validate Lunit INSIGHT DBTan AI solution for digital breast tomosynthesisfor clinical use.

ViaLase Strengthens Executive Team with the Appointments of Tom Frinzi as Executive Chairman of the Board, Richard Lewis, M.D., as Chief Medical Officer, and Shawn O'Neil as Chief Commercial Officer

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Tuesday, November 15, 2022
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ALISO VIEJO, Calif., Nov. 15, 2022 /PRNewswire/ -- ViaLase, Inc. today announced the appointments of Tom Frinzi as Executive Chairman of the Board, Richard Lewis, M.D., as Chief Medical Officer, Shawn O'Neil as Chief Commercial Officer, and Brendan O'Herlihy as Vice President, Global Commercial Operations. The executives will play key roles at ViaLase as the company develops its novel, non-invasive, femtosecond laser with integrated OCT imaging that is accurate to the micron level. This OCT-guided femtosecond laser technology is designed to perform the first femtosecond laser, image-guided, high-precision trabeculotomy (FLigHT) procedure for the treatment of primary open-angle glaucoma (POAG).

Key Points: 
  • This OCT-guided femtosecond laser technology is designed to perform the first femtosecond laser, image-guided, high-precision trabeculotomy (FLigHT) procedure for the treatment of primary open-angle glaucoma (POAG).
  • This puts ViaLase in a position of strength as we prepare for CE Mark and FDA 510k clearance.
  • It's an exciting time in the evolution of the company, and I'm proud to be a part of this journey."
  • Mr. O'Herlihy has 30 years of leadership and management experience in medical device manufacturing; clinical development; and technical, operational, and commercial support.

iXensor announces partnership with Innova Medical Group at 2022 MEDICA

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Monday, November 14, 2022
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DSSELDORF, Germany, Nov. 13, 2022 /PRNewswire/ -- iXensor, the pioneer of mobile health, today announces that a partnership has been established with Innova Medical Group.

Key Points: 
  • DSSELDORF, Germany, Nov. 13, 2022 /PRNewswire/ -- iXensor, the pioneer of mobile health, today announces that a partnership has been established with Innova Medical Group.
  • At MEDICA, Innova Medical Group presents the high-end PHRONESIA Smart Ovulation Test, the first "Powered by iXensor Technology" product, into its range of PHRONESIA self-tests portfolio.
  • Expedited by the COVID-19 pandemic, some medical testing has shifted from central labs to point-of-care and now to consumers' homes as self-testing.
  • Innova Medical Group is a global health screening and diagnostic innovator driven to dramatically improve health outcomes worldwide with equitable, high-value testing solutions.

iXensor announces partnership with Innova Medical Group at 2022 MEDICA

Retrieved on: 
Monday, November 14, 2022
Innova, US, Degenerative disease, Point-of-care testing, US FDA, XLAB d.o.o, MEDICA, Diagnosis, CE marking, Partnership, Biochemistry, COVID-19, CEO, Built-in self-test, Health, Smartphone, Diabetes, ICT, Medtech, Silicon, Medical device, Pharmaceutical industry

DSSELDORF, Germany, Nov. 14, 2022 /PRNewswire/ -- iXensor, the pioneer of mobile health, today announces that a partnership has been established with Innova Medical Group.

Key Points: 
  • DSSELDORF, Germany, Nov. 14, 2022 /PRNewswire/ -- iXensor, the pioneer of mobile health, today announces that a partnership has been established with Innova Medical Group.
  • At MEDICA, Innova Medical Group presents the high-end PHRONESIA Smart Ovulation Test, the first "Powered by iXensor Technology" product, into its range of PHRONESIA self-tests portfolio.
  • Expedited by the COVID-19 pandemic, some medical testing has shifted from central labs to point-of-care and now to consumers' homes as self-testing.
  • Innova Medical Group is a global health screening and diagnostic innovator driven to dramatically improve health outcomes worldwide with equitable, high-value testing solutions.

Novocure Secures CE Mark for New Array

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Friday, November 11, 2022
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Novocure (NASDAQ: NVCR) today announced receipt of CE Mark for its new polymer-based transducer array, called the flex array, designed for more efficient Tumor Treating Fields delivery and greater comfort for patients with glioblastoma.

Key Points: 
  • Novocure (NASDAQ: NVCR) today announced receipt of CE Mark for its new polymer-based transducer array, called the flex array, designed for more efficient Tumor Treating Fields delivery and greater comfort for patients with glioblastoma.
  • Through product innovation, our goal is to deliver higher intensity TTFields to targeted regions without adding toxicity.
  • We believe the new arrays have the potential to meaningfully improve both patient comfort and efficacy of our therapy.
  • With CE Mark for the new arrays, the company will begin a limited market release in Europe.

EQS-News: ​​​​​​​Epigenomics AG reports financial results for the first nine months 2022

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Friday, November 11, 2022
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Berlin (Germany) and San Diego, CA (U.S.A.), November 9, 2022 - Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") today reported financial results (IFRS, unaudited) for the first nine months of 2022.

Key Points: 
  • Berlin (Germany) and San Diego, CA (U.S.A.), November 9, 2022 - Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") today reported financial results (IFRS, unaudited) for the first nine months of 2022.
  • Sales, general and administrative expenses decreased from EUR 5,809 thousand in the previous year to EUR 5,315 thousand in the first nine months of 2022.
  • The financial report for the first nine months of 2022 can be found on Epigenomics' website at: https://www.epigenomics.com/news-investors/financial-reports/ .
  • Epigenomics AG will host a conference call for analysts and investors today at 4.00 pm (CET) / 10.00 am (EDT).

Stereotaxis Reports 2022 Third Quarter Financial Results

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Thursday, November 10, 2022
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ST. LOUIS, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the third quarter ended September 30, 2022.

Key Points: 
  • ST. LOUIS, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the third quarter ended September 30, 2022.
  • Revenue for the third quarter of 2022 totaled $7.7 million, compared to $9.1 million in the prior year third quarter.
  • At September 30, 2022, Stereotaxis had cash and cash equivalents, including restricted cash, of $32.4 million and no debt.
  • Stereotaxis will host a conference call and webcast today, November 10, 2022, at 10:00 a.m. Eastern Time.

Profusa, Inc., a Digital Health Company, Pioneering the Next Generation of Personalized Medicine, to Become a Publicly Traded Company Via Merger with NorthView Acquisition Corp

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Monday, November 7, 2022
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Upon closing of the transaction, NorthView will be renamed Profusa Inc. (the Combined Company).

Key Points: 
  • Upon closing of the transaction, NorthView will be renamed Profusa Inc. (the Combined Company).
  • Profusa is based in Emeryville, CA and is a digital health company that is pioneering the next generation of personalized medicine via the development of novel tissue-integrated biosensors.
  • Profusas technology enables continuous transmission of wireless and cloud based actionable medical-grade data for personal, professional and medical use.
  • Profusa, aDelawarecorporation, is a digital health company that is pioneering the next generation of personalized medicine as a leading developer of novel tissue integrated biosensors.