PMA

QIAGEN and Myriad Genetics develop distributable homologous recombination deficiency test for global research and companion diagnostics applications

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木曜日, 5月 30, 2024
NGS, Partnership, Patient, DNA, CDX, PMDA, Ovarian cancer, Myriad Genetics, QGEN, Clinical trial, MYGN, BRCA2, FDA, Neoplasm, Senior, Research, PMA, GIS, Cancer, Genetics, IP, Biomarker, BRCA1, QIAGEN, Innovation, AstraZeneca, HRD

Next-generation-sequencing-based homologous recombination deficiency (HRD) assay based on QIAGEN’s QIAseq xHYB technology, QIAGEN Digital Insight solutions, and Myriad’s proprietary, FDA-approved MyChoice CDx® biomarkers

Key Points: 
  • Next-generation-sequencing-based homologous recombination deficiency (HRD) assay based on QIAGEN’s QIAseq xHYB technology, QIAGEN Digital Insight solutions, and Myriad’s proprietary, FDA-approved MyChoice CDx® biomarkers
    VENLO, The Netherlands and SALT LAKE CITY, May 30, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Myriad Genetics (NASDAQ: MYGN) today announced they will develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency (HRD) status.
  • The project builds on the recently announced master collaboration agreement between the two companies.
  • “Our partnership with Myriad Genetics underscores a shared commitment to advancing cancer diagnostics.
  • The combined regulatory expertise of QIAGEN and Myriad enables seamless compliance and integration in clinical and companion diagnostic applications.

QIAGEN and Myriad Genetics develop distributable homologous recombination deficiency test for global research and companion diagnostics applications

Retrieved on: 
木曜日, 5月 30, 2024
NGS, Partnership, Patient, DNA, CDX, PMDA, Ovarian cancer, Myriad Genetics, QGEN, Clinical trial, MYGN, BRCA2, FDA, Neoplasm, LOH, Senior, Research, PMA, GIS, Cancer, Genetics, IP, BRCA1, QIAGEN, Innovation, AstraZeneca, HRD

Venlo, the Netherlands, and Salt Lake City, Utah, May 30, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Myriad Genetics (NASDAQ: MYGN) today announced they will develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency (HRD) status.

Key Points: 
  • Venlo, the Netherlands, and Salt Lake City, Utah, May 30, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Myriad Genetics (NASDAQ: MYGN) today announced they will develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency (HRD) status.
  • “Our partnership with Myriad Genetics underscores a shared commitment to advancing cancer diagnostics.
  • The IP license grants QIAGEN the capability to collaborate with pharmaceutical partners to create an IVD-validated test, intended for use as a companion diagnostic outside of the United States.
  • The combined regulatory expertise of QIAGEN and Myriad enables seamless compliance and integration in clinical and companion diagnostic applications.

AVITA Medical Announces FDA Approval of RECELL GO

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木曜日, 5月 30, 2024
ASX, Avita Medical, Patient, Burn, Food, FDA, Skin, PMA, AVH, Pharmaceutical industry

This next-generation device significantly reduces the training burden on medical staff, improves workflow efficiency in the operating room, and controls the RECELL Enzyme™ incubation time to ensure optimal cell yield and viability.

Key Points: 
  • This next-generation device significantly reduces the training burden on medical staff, improves workflow efficiency in the operating room, and controls the RECELL Enzyme™ incubation time to ensure optimal cell yield and viability.
  • These advancements simplify the user interface, enabling medical teams to provide quality care readily and consistently to their patients.
  • "FDA approval of RECELL GO marks a paradigm shift in the treatment of partial-thickness and full-thickness wounds,” said Jim Corbett, Chief Executive Officer of AVITA Medical.
  • The supplement follows the original PMA of RECELL Autologous Cell Harvesting Device and subsequent PMA supplements.

InspireMD Announces Presentation of Positive One-Year Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial of CGuard at LINC 2024  

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火曜日, 5月 28, 2024
Patient, NSPR, Stoke, Risk, CAS, Clinical trial, Trial of the century, OhioHealth, TCAR, Stroke, LINC, Death, EPS, PMA, Carotid artery stenosis, Micronet, Incidence, TEL, Mortality, Myocardial infarction, CEA, Pharmaceutical industry

TEL AVIV, Israel, and MIAMI, May 28, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced the presentation of positive one-year outcomes from its C-GUARDIANS IDE clinical trial of the CGuard™ Carotid Stent System for the treatment of carotid artery stenosis at this year’s Leipzig Interventional Course (LINC) 2024, which is being held May 28-31, in Leipzig, Germany.

Key Points: 
  • Marvin Slosman, chief executive officer of InspireMD, stated, “We are very pleased to have such a significant presence at this year’s LINC conference, highlighted by a presentation of the primary endpoint results from our C-GUARDIANS clinical study.
  • The independently adjudicated major adverse event rates through one-year are the lowest reported to date from any carotid stent or embolic protection device pivotal trial.
  • These data confirm the potential ‘neuroprotective properties’ of this unique MicroNet technology, offering an outstanding front-line option to consider for each patient with obstructive carotid artery disease."
  • The presentation is available on our website at: Clinical Presentations - InspireMD

Press news: Sequana Medical announces positive outcome of Day 100 meeting with FDA regarding PMA application for alfapump®

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水曜日, 5月 22, 2024
Patient, Sequana, Liver disease, Food, Ascites, Heart failure, Letter, FDA, Trial of the century, Marketing, Overload, Q3, PMA, Cancer, Software, Brussels Stock Exchange, Environment, Cirrhosis, Pharmaceutical industry

The PMA application for the alfapump system, which was based on the successful execution of Sequana Medical’s pivotal POSEIDON study, was accepted for substantive review on 29 January 2024.

Key Points: 
  • The PMA application for the alfapump system, which was based on the successful execution of Sequana Medical’s pivotal POSEIDON study, was accepted for substantive review on 29 January 2024.
  • Following a review of this application by the FDA, the Company received a “Day 90” major deficiency letter and a “Day 100” meeting was held with FDA to align on key findings.
  • The Company continues to evaluate its financing options to achieve FDA approval and prepare for commercial launch of the alfapump.
  • We look forward to addressing the remaining questions from FDA and anticipate approval before the end of Q1 2025.”

SeaStar Medical Reports First Quarter 2024 Financial Results and Provides a Business Update

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火曜日, 5月 14, 2024
Neutrophil, Risk, European Journal, FDA, Chronic kidney disease, Accounting, Cardiorenal syndrome, Research, Therapy, G&A, CRRT, Acute kidney injury, Standard of care, Sepsis, Bangladesh Technical Education Board, Inflammation, Hospital, University, ICU, Patent, Nephron, Acute respiratory distress syndrome, Division, KRT, University of Michigan, AKI, Dialysis, Clinical trial, CKRT, Safety, Marketing, HDE, PMA, SCD, Internal medicine, Clinical study design, Hepatorenal syndrome, HUD, Heart, Heart failure, Manuscript, Monocyte, Mortality, Survival rate, Quality of life, White, Pharmaceutical industry

DENVER, May 14, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three months ended March 31, 2024 and provides a business update.

Key Points: 
  • DENVER, May 14, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three months ended March 31, 2024 and provides a business update.
  • In March 2024 the Company sponsored an industry symposium titled “ New Therapies in Pediatric Acute Kidney Injury ” at the AKI & CRRT 2024 conference.
  • Mr. Green brings to SeaStar Medical extensive financial experience at public medical device and therapeutics companies.
  • The net loss for the first quarter of 2024 was $12.7 million, or $0.19 per share on 67.1 million weighted-average shares outstanding.

Guardant Health Stock Trading Temporarily Halted; FDA Panel to Assess Premarket Approval Application for Shield Blood Test for Colorectal Cancer Screening

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木曜日, 5月 23, 2024
Research, General Health, Professional Services, Oncology, Technology, Artificial Intelligence, Genetics, Data Analytics, Science, FDA, Other Science, Health, Colorectal cancer, PMA, Molecule, Food

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that Nasdaq has temporarily halted trading of the company's stock.

Key Points: 
  • Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that Nasdaq has temporarily halted trading of the company's stock.
  • The Molecular and Clinical Genetics Panel of the U.S. Food and Drug Administration (FDA) Medical Devices Advisory Committee will meet today to review the premarket approval (PMA) application for ShieldTM, Guardant Health’s blood test to screen for colorectal cancer in average-risk adults.
  • The panel meeting is scheduled to begin at 9:30 a.m.
  • FDA advisory committees provide independent expert advice and non-binding recommendations to the FDA on certain products to help the agency make sound decisions based on the available science.

FDA Advisory Committee Panel Strongly Recommends Approval of Shield™ Blood Test for Colorectal Cancer Screening as a Primary Non-Invasive Screening Option

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金曜日, 5月 24, 2024
Oncology, Medical Supplies, Health, FDA, Medical Devices, Other Health, General Health, Patient, Colorectal cancer, Massachusetts General Hospital, Risk, Food, Disease, Helmy Eltoukhy, MD, Large intestine, PMA, Cancer, Harvard Medical School, Death, CRC, Hospital, Molecule, Vaccine

The recommendation signals the advisory committee panel's consensus on Shield's safety and effectiveness with its proposed intended use, and their conclusion that its benefits as a primary non-invasive screening option outweigh any potential risks.

Key Points: 
  • The recommendation signals the advisory committee panel's consensus on Shield's safety and effectiveness with its proposed intended use, and their conclusion that its benefits as a primary non-invasive screening option outweigh any potential risks.
  • The committee offers valuable perspective and non-binding recommendations for the FDA to factor in alongside other considerations during approval decisions.
  • “The advisory committee’s strong support for the approval of Shield reinforces the crucial role that a blood test option can have in improving CRC screening rates for those at average risk,” said AmirAli Talasaz, co-CEO of Guardant Health.
  • “Despite the importance of detecting colorectal cancer early, there are notable barriers that can deter average-risk Americans from completing existing screening methods.

GE HealthCare Tops List for Third Year in a Row with Highest Number of AI-Enabled Medical Device Authorizations

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水曜日, 5月 22, 2024
Biotechnology, Technology, FDA, Health, Pharmaceutical, Health Technology, Medical Devices, Software, Artificial Intelligence, Surgery, Clinical Trials, Machine learning, Food, Mediastinum, Liver, CHO, Artificial intelligence, Radiation, PVA, Medical device, AI, De novo, PMA, Caption, Physicist, GE HealthCare, SNR, Food and Drug Administration

GE HealthCare also topped the list when it was updated by the FDA in 2022 and 2023.

Key Points: 
  • GE HealthCare also topped the list when it was updated by the FDA in 2022 and 2023.
  • “GE HealthCare is committed to pushing the boundaries of what is possible, utilizing advanced technologies like AI, to help deliver the future of healthcare.
  • GE HealthCare’s continued leadership in AI-based medical device authorizations shows our dedication to deliver ground-breaking technology that transforms healthcare and enhances patient outcomes,” said Dr. Taha Kass-Hout, Chief Science and Technology Officer at GE HealthCare.
  • Included in the list are 72 GE HealthCare 510(k) clearances or authorizations, including those from recently acquired companies, BK Medical, Caption Health and MIM Software.

Evolus Announces Positive Data from Pivotal Trial for First Two Evolysse™ Dermal Filler Products at 2024 SCALE Meeting

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月曜日, 5月 20, 2024
Research, Luxury, Pharmaceutical, Lifestyle, Consumer, Cosmetics, Retail, Clinical Trials, Science, Biotechnology, Women, FDA, Health, Patient, PMA, NLF, Pharmaceutical industry

Data were presented at the 2024 SCALE Meeting on May 17, 2024, in Nashville.

Key Points: 
  • Data were presented at the 2024 SCALE Meeting on May 17, 2024, in Nashville.
  • “Achieving positive topline results in our NLF study is a pivotal step supporting the upcoming submission of our Premarket Approval application for the U.S. launch of our dermal filler lines.
  • Evolus remains on track to submit Premarket Approval (PMA) applications for the first two Evolysse™ dermal filler products with the FDA within the next 90 days.
  • The Evolysse™ Lift filler will be positioned as the most versatile and highest use filler in the product line.