CE marking

Butterfly Medical Welcomes Experienced Urology Executive to its Helm

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토요일, 5월 4, 2024
BPH, Gastroenterology, Retention rate, Elective surgery, Malignancy, Urology, Gynaecology, Novartis, Patient, MacCarthy Mor dynasty, Butterfly, CE marking, Pharmaceutical industry

With over 20 years of global healthcare leadership experience, Mr. MacCarthy has led teams to successfully commercialize multiple medical devices in fields including gastroenterology, pulmonology, thoracic surgery, gynecology and urology.

Key Points: 
  • With over 20 years of global healthcare leadership experience, Mr. MacCarthy has led teams to successfully commercialize multiple medical devices in fields including gastroenterology, pulmonology, thoracic surgery, gynecology and urology.
  • Mr. MacCarthy was most recently head of the Urology and Gynecology business unit for Olympus America, Inc.
    "We are thrilled to welcome Pat as our new CEO for Butterfly Medical", said Greg Parekh, Chairman of the Board for Butterfly Medical, Managing Partner of New Rhein Healthcare Investors and former Head of M&A at Novartis.
  • "With deep cross-functional expertise in large and start-up healthcare companies, Pat is well positioned to lead Butterfly Medical to clinical and commercial success.
  • "I chose Butterfly Medical because I saw significant value in its unique technology and because of the strength of the management team, clinicians, partners and investors.

Stratus® Medical announces continued expansion of its intellectual property coverage in Europe with additions to its global patent portfolio for the NIMBUS® Electrosurgical RF Multitined Expandable Electrode and registration of a Community design for new

Retrieved on: 
월요일, 4월 29, 2024
Pain, FDA, Unitary, Unitary patent, PCT, Patient, Medicine, RF, Community, Chronic pain, CE marking

Both patents have been validated in the United Kingdom, Ireland, and Spain and as Unitary Patents covering France, Germany, Italy, and all other countries under the Unitary Patent system.

Key Points: 
  • Both patents have been validated in the United Kingdom, Ireland, and Spain and as Unitary Patents covering France, Germany, Italy, and all other countries under the Unitary Patent system.
  • Additionally, the Company has registered a Community design with the European Union Intellectual Property Office for its forthcoming platform technology, which is in late-stage development.
  • Bret Boudousquie, Stratus Medical's CEO, stated, "Stratus Medical has made significant investment in product development projects to advance RF technology for the treatment of pain.
  • These recently issued European patents are particularly important as we continue to gain momentum with NIMBUS in Europe."

Single Pass, Inc. Announces FDA Clearance of its Kronos Biopsy Closure Device

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월요일, 4월 29, 2024
FDA, Safety, Food, Partnership, Patient, Health, MDR, CE marking, Medical device

LAKE FOREST, Calif., April 29, 2024 /PRNewswire/ -- Single Pass, Inc. is proud to announce that its Class II Kronos biopsy closure device has received clearance from the U.S. Food and Drug Administration (FDA).

Key Points: 
  • LAKE FOREST, Calif., April 29, 2024 /PRNewswire/ -- Single Pass, Inc. is proud to announce that its Class II Kronos biopsy closure device has received clearance from the U.S. Food and Drug Administration (FDA).
  • The FDA has determined the device is substantially equivalent to predicate devices regarding its safety and effectiveness.
  • "We are thrilled to have received FDA clearance for our Kronos biopsy closure device," said Bill Colone, Co-founder, and CEO of Single Pass.
  • "The Kronos device represents a significant advancement, offering healthcare professionals a reliable and efficient solution for post biopsy bleeding and improved patient care."

EQS-News: Lindis Blood Care Announces Positive Top-Line Results from Clinical Certification Study REMOVE with CATUVAB® to Enable Autologous Blood Transfusions in Cancer Surgeries

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금요일, 5월 3, 2024
FDA, Cancer, Prostate, Cell, Risk, Blood, Filter, CE marking, Cytokine, Trauma, Immunosuppression, Intensive care medicine, MD, Carcinoma, PILOT, Pain management, Patient, Lung, Teaching hospital, Clinical trial, IBS, Medical imaging

Convincing safety profile supports use of CATUVAB® during high blood loss cancer surgeries.

Key Points: 
  • Convincing safety profile supports use of CATUVAB® during high blood loss cancer surgeries.
  • Following these positive results, Company has initiated process to receive CE Mark in Europe and FDA conformity in the US.
  • Lindis Blood Care, a company aiming to set a new standard for blood management during cancer surgeries with its medical device CATUVAB®, announced today excellent top-line results from the REMOVE certification study, a confirmatory open-label, multicenter clinical study, that enrolled more than 130 patients to assess CATUVAB® for use during intraoperative blood salvage (IBS) procedures in cancer surgeries.
  • CATUVAB® is designed to reliably remove cells from EpCAM (epithelial cell adhesion molecule)-positive tumors from the blood of cancer patients.

Cardiawave appoints Olivier Pierron as its Chief Executive Officer

Retrieved on: 
화요일, 4월 16, 2024
Cardiology, Biotechnology, Pharmaceutical, Medical Supplies, Health, Medical Devices, Clinical Trials, Other Health, Tech, CE marking, FIH, Research, France Biotech, IPO, Patient, Acquisition, Multimedia, Organization, Ultrasound, Pharmaceutical industry

Cardiawave SA, a French Medtech company that has developed an innovative Non-Invasive Ultrasound Therapy (NIUT) device for the treatment of severe symptomatic calcific aortic stenosis, is delighted to announce the appointment of Olivier Pierron as its new Chief Executive Officer.

Key Points: 
  • Cardiawave SA, a French Medtech company that has developed an innovative Non-Invasive Ultrasound Therapy (NIUT) device for the treatment of severe symptomatic calcific aortic stenosis, is delighted to announce the appointment of Olivier Pierron as its new Chief Executive Officer.
  • View the full release here: https://www.businesswire.com/news/home/20240416024431/en/
    Before joining Cardiawave, Olivier Pierron held executive roles at some well-known companies in the sector, showing his capabilities as a manager and innovator in organizations at various stages of maturity.
  • His international experience, combined with his involvement in development, acquisition and IPO transactions, makes him a sound strategic choice to lead Cardiawave towards new horizons.
  • Olivier Pierron, Cardiawave’s new CEO, said: “The approach developed by Cardiawave is unique and complements the existing range of cardiology treatments.

Global Urine Output Monitoring Systems Market is Projected to Grow at a CAGR of ~5% by 2030 | DelveInsight

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목요일, 4월 25, 2024
Sentinel, Conditional sentence, FDA, Kidney, Nursing care plan, Urinary tract infection, Risk, Prevalence, CDC, 3i, Diabetes, Machine learning, Artificial intelligence, Intensive care unit, Urine, Patient safety, CKD, Dehydration, Patient, Operating, LAS, Data collection, Data management, Health, System, Chronic kidney disease, Intensive care medicine, Algorithm, Overalls, CE marking, Medical device

LAS VEGAS, April 25, 2024 /PRNewswire/ -- DelveInsight's Urine Output Monitoring Systems Market Insights report provides the current and forecast market analysis, individual leading urine output monitoring systems companies' market shares, challenges, urine output monitoring systems market drivers, barriers, trends, and key market urine output monitoring systems companies in the market.

Key Points: 
  • LAS VEGAS, April 25, 2024 /PRNewswire/ -- DelveInsight's Urine Output Monitoring Systems Market Insights report provides the current and forecast market analysis, individual leading urine output monitoring systems companies' market shares, challenges, urine output monitoring systems market drivers, barriers, trends, and key market urine output monitoring systems companies in the market.
  • Notable urine output monitoring systems companies such as BD, Potrero Medical Inc., 3i Group plc, Serenno Medical, RenalSense Ltd., FIZE Medical, and several others, are currently operating in the urine output monitoring systems market.
  • To read more about the latest highlights related to the urine output monitoring systems market, get a snapshot of the key highlights entailed in the Global Urine Output Monitoring Systems Market Report
    Urine output monitoring systems play a crucial role in healthcare settings, offering real-time insights into a patient's renal function and overall health status.
  • To know more about why North America is leading the market growth in the urine output monitoring systems market, get a snapshot of the Urine Output Monitoring Systems Market Outlook
    The urine output monitoring systems market dynamics are witnessing significant evolution driven by several factors.

Global Urine Output Monitoring Systems Market is Projected to Grow at a CAGR of ~5% by 2030 | DelveInsight

Retrieved on: 
목요일, 4월 25, 2024
Sentinel, Conditional sentence, FDA, Kidney, Nursing care plan, Urinary tract infection, Risk, Prevalence, CDC, 3i, Diabetes, Machine learning, Artificial intelligence, Intensive care unit, Urine, Patient safety, CKD, Dehydration, Patient, Operating, LAS, Data collection, Data management, Health, System, Chronic kidney disease, Intensive care medicine, Algorithm, Overalls, CE marking, Medical device

LAS VEGAS, April 25, 2024 /PRNewswire/ -- DelveInsight's Urine Output Monitoring Systems Market Insights report provides the current and forecast market analysis, individual leading urine output monitoring systems companies' market shares, challenges, urine output monitoring systems market drivers, barriers, trends, and key market urine output monitoring systems companies in the market.

Key Points: 
  • LAS VEGAS, April 25, 2024 /PRNewswire/ -- DelveInsight's Urine Output Monitoring Systems Market Insights report provides the current and forecast market analysis, individual leading urine output monitoring systems companies' market shares, challenges, urine output monitoring systems market drivers, barriers, trends, and key market urine output monitoring systems companies in the market.
  • Notable urine output monitoring systems companies such as BD, Potrero Medical Inc., 3i Group plc, Serenno Medical, RenalSense Ltd., FIZE Medical, and several others, are currently operating in the urine output monitoring systems market.
  • To read more about the latest highlights related to the urine output monitoring systems market, get a snapshot of the key highlights entailed in the Global Urine Output Monitoring Systems Market Report
    Urine output monitoring systems play a crucial role in healthcare settings, offering real-time insights into a patient's renal function and overall health status.
  • To know more about why North America is leading the market growth in the urine output monitoring systems market, get a snapshot of the Urine Output Monitoring Systems Market Outlook
    The urine output monitoring systems market dynamics are witnessing significant evolution driven by several factors.

Roche obtains CE Mark for first companion diagnostic to identify patients with HER2-low metastatic breast cancer eligible for ENHERTU

Retrieved on: 
수요일, 4월 10, 2024
Breast cancer, FDA, Patient, Cancer, Daiichi Sankyo, Lung cancer, HER2, Food, ROG, Marie Cassidy, ADC, Food and Drug Administration, AstraZeneca, CE marking, Medical imaging

ENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.

Key Points: 
  • ENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.
  • To determine a patient's HER2 status, pathologists evaluate, or score, the level of HER2 protein expressed in breast cancer tissue samples.
  • However, half of all patients with metastatic breast cancer express low levels of HER2 which historically classified them as HER2-negative.
  • Breast cancer has surpassed lung cancer as the most commonly diagnosed cancer, with an estimated 2.3 million new cases diagnosed worldwide each year.

Roche obtains CE Mark for first companion diagnostic to identify patients with HER2-low metastatic breast cancer eligible for ENHERTU

Retrieved on: 
수요일, 4월 10, 2024
Breast cancer, FDA, Patient, Cancer, Daiichi Sankyo, Lung cancer, HER2, Food, ROG, Marie Cassidy, ADC, Food and Drug Administration, AstraZeneca, CE marking, Medical imaging

ENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.

Key Points: 
  • ENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.
  • To determine a patient's HER2 status, pathologists evaluate, or score, the level of HER2 protein expressed in breast cancer tissue samples.
  • However, half of all patients with metastatic breast cancer express low levels of HER2 which historically classified them as HER2-negative.
  • Breast cancer has surpassed lung cancer as the most commonly diagnosed cancer, with an estimated 2.3 million new cases diagnosed worldwide each year.

Increased Adoption of Artificial Intelligence Across the Healthcare Industry Driving Strong Market Growth

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수요일, 3월 27, 2024
PWD, African Americans, Conditional sentence, Patient, Big data, Intellectual property, Lidar, Artificial intelligence, Certification, AMD, Risk, Sony, PALM, 3D, NIH, Treatment, Culture, Safety, OTCQB, CE marking, Weather, SSS, Prevalence, Radiology, Intelligence, Family, PLTR, Depth perception, Triage, News, Historical trauma, Cancer, AI, MDR, MPH, Butterfly, Health equity, Diagnosis, Arrhythmia, Health, Butterfly network, Growth, Patent, Perception, SNM, PTAB, AIP, FAAFP, FRCS, Medical device

In diagnostics, AI enables healthcare providers to make the most appropriate treatment decisions for their patients.

Key Points: 
  • In diagnostics, AI enables healthcare providers to make the most appropriate treatment decisions for their patients.
  • Mordor Intelligence continued: “The increased prevalence of cancer and the high burden of other chronic diseases are, in turn, increasing the demand for accurate diagnosis and treatment.
  • This is likely to increase the adoption of AI for early diagnosis purposes, ultimately boosting the market growth.
  • The use of artificial intelligence in the North American healthcare market is being driven by the increasing use of advanced technology in healthcare systems, the growth in funding of AI-based startups, the rising burden of chronic diseases in the country, the growing need to reduce healthcare costs, and the implementation of big data in healthcare.