Kidney

RSNA: Early Coronary Disease, Impaired Heart Function Found in Asymptomatic People with HIV

Retrieved on: 
Thursday, April 4, 2024
Biomedicine, Cardiovascular disease, MRI, Coronary artery disease, HIV, Didanosine, Viral load, Education, Patient, Facial muscles, Research, Kidney, University, Death, Physical examination, NIH, Society, Life expectancy, Risk, Moyamoya disease, OAK, World Health Organization, RSNA, DRS, Heart, Radiation, Bangladesh Technical Education Board, Digestive, Synthetic control method, Health, Person, Pharmaceutical industry

OAK BROOK, Ill., April 4, 2024 /PRNewswire-PRWeb/ -- A new study found increased coronary vessel wall thickness that was significantly associated with impaired diastolic function in asymptomatic, middle-aged individuals living with HIV. The study was published today in Radiology: Cardiothoracic Imaging, a journal of the Radiological Society of North America (RSNA).

Key Points: 
  • A new study found increased coronary vessel wall thickness that was significantly associated with impaired diastolic function in asymptomatic, middle-aged individuals living with HIV.
  • The ability to detect early coronary artery disease in persons living with HIV and potentially prevent detrimental effects on the heart muscle is important.
  • This research shows the impact of HIV on developing subtle subclinical coronary artery disease and its effects on heart function.
  • "This research shows the impact of HIV on developing subtle subclinical coronary artery disease and its effects on heart function."

BLACK HEALTH MATTERS TO HOST FREE SPRING HEALTH SUMMIT AND EXPO IN WASHINGTON, D.C.

Retrieved on: 
Wednesday, April 3, 2024
Kidney, Glucose, LDL, Exercise, Hepatitis C, Jabari, Black, BMS, National Pan-Hellenic Council, Patient, Vertex, Lunch, PSA, Legislation, Education, Gallaudet University, Omega Psi Phi, Incontinence, Johnson & Johnson, Cholesterol, WRC-TV, Triglyceride, Hypertension, Sanofi, Doctor of Pharmacy, Leukemia, Memory, Food, HDL, Phi Beta Sigma, Health, COVID-19 vaccine, Conference, BHM, COVID-19, All My Children, Howard University Hospital, Breakfast, Kidney disease, Diet, Guru, Sibley Memorial Hospital, Pharmaceutical industry

WASHINGTON, April 3, 2024 /PRNewswire/ -- Black Health Matters (BHM) – a leading nonprofit health advocacy organization that provides health and wellness information to the Black community – will host its annual Black Health Matters Spring Health Summit and Expo in Washington, D.C. on Saturday, April 13. As part of the award-winning health summit series, the free, one-day event will be held at the Kellogg Conference Hotel at Gallaudet University at 800 Florida Avenue, N.E., Washington, DC 20002 and includes celebrity hosts, medical professionals, health screenings, prizes, breakfast, and lunch. The event is open to the public and will begin at 8:30 a.m. with breakfast and conclude at 3:30 p.m.

Key Points: 
  • Popular health-focused event to feature free screenings, conversations with experts and celebrities
    WASHINGTON, April 3, 2024 /PRNewswire/ -- Black Health Matters (BHM) – a leading nonprofit health advocacy organization that provides health and wellness information to the Black community – will host its annual Black Health Matters Spring Health Summit and Expo in Washington, D.C. on Saturday, April 13.
  • After over a decade of hosting the popular health-focused summits, this will be the first in Washington, D.C. for Black Health Matters.
  • The Black Health Matters Spring Summit & Expo is sponsored by leading health organizations including Sanofi|Regeneron, Johnson & Johnson Health Care Systems, Johnson & Johnson Innovative Medicine, Research Includes Me, BMS, Sanofi, argenx, Vertex and CISCRP.
  • Notable partners are Howard University Hospital; DC Department of Health Care Finance; Precision Wellness; and American Association of Kidney Patients.

BioVaxys Announces Allowance of DPX Formulation Patent for the United States and Filing of Additional International Patent Applications for Phase 1 DPX SurMAGE

Retrieved on: 
Wednesday, April 3, 2024
Aggression, A9, Immunotherapy, Patent, Infection, Patient, Lung, Neoplasm, Epitope, IMV, FRA, Cancer, Messenger, Bladder cancer, Protein, Trial of the century, CHU, APC, European, Antibody, Immune system, Kidney, Intellectual property, Therapy, Antigen, Peptide, Vaccine

DPX™ is a proprietary lipid-based delivery platform with no aqueous component that can be formulated with a range of packaged antigens, proteins, peptides, mRNA, or small molecules.

Key Points: 
  • DPX™ is a proprietary lipid-based delivery platform with no aqueous component that can be formulated with a range of packaged antigens, proteins, peptides, mRNA, or small molecules.
  • Its unique "no release" mechanism of action allows antigen presenting cells (APCs) to be attracted to the injection site, facilitating a robust and sustained immune response.
  • BioVaxys President and Chief Operating Officer Kenneth Kovan stated "Allowance of this important patent in the United States greatly expands the value of our IP and antigen delivery platform with potential partners.
  • We will be reconvening with the study team at CHU de Québec-Université Laval to plan further development."

Olympus Announces FDA Clearance of RenaFlex™, Its First Single-use Flexible Ureteroscope

Retrieved on: 
Tuesday, April 2, 2024
System, U.S. FDA, Burns, Urology, Small Business Saturday, Lithotripsy, Endoscopy, Risk, Patient, Perforation, Infection, Health professional, Bleeding, Ureteroscopy, Kidney, Ureter, Urethra, Physician, Medical imaging

CENTER VALLEY, Pa., April 2, 2024 /PRNewswire/ -- Olympus, a global medical technology company committed to making people's lives healthier, safer and more fulfilling, announced today U.S. FDA 510(k) clearance of its first single-use ureteroscope system, RenaFlex™, with full market availability to be announced at a later date.

Key Points: 
  • The RenaFlex single-use flexible ureteroscope system is used to access and visualize the urinary tract to diagnose and treat urinary diseases and disorders, such as kidney stones.
  • The RenaFlex ureteroscope can be used with endotherapeutic accessories to perform diagnostic and therapeutic procedures within the urinary tract.
  • The RenaFlex Single-use Ureteroscope works in combination with the compatible CV-S1 Video System Center for flexible Single-use Endoscopes.
  • Visit the urology product page for more information about the complete line of Olympus urology solutions.

IceCure Submits FDA Regulatory Filing for New XSense™ Cryoablation System with Cryoprobes

Retrieved on: 
Tuesday, April 2, 2024
De novo, Freezing, Neoplasm, FDA, Liver, Neurology, Breast cancer, Kidney, Medical imaging

CAESAREA, Israel, April 2, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has filed a 510(k) submission with the United States Food and Drug Administration ("FDA") for clearance of its next-generation single probe cryoablation system, the XSense™ System and cryoprobes. The filing contains a request for clearance for all of the indications for which ProSense® has already received the requisite FDA clearance, including general minimally invasive cryoablation applications for the kidney, liver, fibroadenomas and neurology.

Key Points: 
  • CAESAREA, Israel, April 2, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has filed a 510(k) submission with the United States Food and Drug Administration ("FDA") for clearance of its next-generation single probe cryoablation system, the XSense™ System and cryoprobes.
  • The filing contains a request for clearance for all of the indications for which ProSense® has already received the requisite FDA clearance, including general minimally invasive cryoablation applications for the kidney, liver, fibroadenomas and neurology.
  • This new application for IceCure's next-generation single probe XSense™ with cryoprobes is based on the current clearance of the ProSense® System, and is being processed separately from the Company's De Novo application for the breast cancer indication.
  • "As our ProSense® single probe cryoablation system builds market traction globally, we continue to develop our technology pipeline with innovative single and multi-probe systems," stated IceCure CEO Eyal Shamir.

China Medical University Hospital Develops "AISIA" to Diagnose Acute Ischemic Stroke in 90 Seconds to Assist Doctors in Making Medical Decisions

Retrieved on: 
Tuesday, April 2, 2024
Diagnosis, Control, Stroke, Blood pressure, Speech, Brain, Pneumonia, Brain ischemia, Kidney, NCCT, Physician, Paralysis, Risk, External carotid artery, Patient, Contrast-induced nephropathy, Cerebrovascular disease, Mortality, Long-term care, Death, Judgement, Deep learning, Nausea, Atherosclerosis, Bleeding, Heart, Neurology, Agent handling, Ministry, Shadow, CTP, Vomiting, Artificial intelligence, Rehabilitation, Dysarthria

The models analyze NCCT and CTP images to detect acute ischemic stroke, as well as to identify the ischemic core and penumbra.

Key Points: 
  • The models analyze NCCT and CTP images to detect acute ischemic stroke, as well as to identify the ischemic core and penumbra.
  • This assist physicians in making decision of acute ischemic stroke management.
  • This system can determine the presence of acute ischemic stroke in approximately 90 seconds.
  • In this way, the facilitated AISIA platform means a lot for ischemic stroke patients and medical experts as well.

CONCEPT MEDICAL RECEIVES US FDA IDE APPROVAL FOR MAGICTOUCH AVF INDICATION, THEIR FIFTH US CLINICAL STUDY APPROVAL FOR THE MAGICTOUCH PORTFOLIO

Retrieved on: 
Tuesday, April 2, 2024
Chronic kidney disease, DCB, Kidney disease, Patient, Arteriovenous fistula, IDE, Sirolimus, Quality of life, Trial of the century, Fistula, Clinical trial, Kidney, AVF, PMA, US FDA, Safety, Food, FDA, Health, Pharmaceutical industry

Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.

Key Points: 
  • Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.
  • The Company has been granted four other US FDA IDE approvals for its MagicTouch product portfolio for different indications.
  • This US FDA IDE approval allows Concept Medical to conduct pivotal clinical studies to gather safety and efficacy data for the MagicTouch Sirolimus Coated Balloon in A.V.
  • With a focus on advancing patient care through innovation, Concept Medical remains dedicated to improving patients' lives worldwide.

CONCEPT MEDICAL RECEIVES US FDA IDE APPROVAL FOR MAGICTOUCH AVF INDICATION, THEIR FIFTH US CLINICAL STUDY APPROVAL FOR THE MAGICTOUCH PORTFOLIO

Retrieved on: 
Tuesday, April 2, 2024
Chronic kidney disease, DCB, Kidney disease, Patient, Arteriovenous fistula, IDE, Sirolimus, Quality of life, Trial of the century, Fistula, Clinical trial, Kidney, AVF, PMA, US FDA, Safety, Food, FDA, Health, Pharmaceutical industry

Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.

Key Points: 
  • Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.
  • The Company has been granted four other US FDA IDE approvals for its MagicTouch product portfolio for different indications.
  • This US FDA IDE approval allows Concept Medical to conduct pivotal clinical studies to gather safety and efficacy data for the MagicTouch Sirolimus Coated Balloon in A.V.
  • With a focus on advancing patient care through innovation, Concept Medical remains dedicated to improving patients' lives worldwide.

Alebund's Innovative Investigational Drug AP303 Receives FDA Orphan Drug Designation (ODD) for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Retrieved on: 
Friday, March 29, 2024
ODD, Diagnosis, Kidney disease, Prevalence, Kidney, Renal replacement therapy, Patient, Orphan, ESKD, FDA, Pharmaceutical industry

"We are very excited that AP303 has been granted Orphan Drug Designation by the FDA", Dr. Gavin Xia, Co-founder, Chairman, and CEO of Alebund commented.

Key Points: 
  • "We are very excited that AP303 has been granted Orphan Drug Designation by the FDA", Dr. Gavin Xia, Co-founder, Chairman, and CEO of Alebund commented.
  • "It is an important milestone for Alebund as well as our efforts to address the significant unmet medical needs with ADPKD.
  • AP303, a novel drug candidate developed in-house by Alebund, has demonstrated a meaningful improvement of renal survival in an ADPKD mice model.
  • This Orphan Drug Designation reflects the need for more new treatment options and the potential for AP303 to address the pressing needs of people living with ADPKD.

Akebia Receives FDA Approval of Vafseo® (vadadustat) Tablets for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis

Retrieved on: 
Thursday, March 28, 2024
CSL Vifor, Thrombosis, Myocardial infarction, Conference, Organization, Tablet, Caregiver, Anemia, Physician, CKD, Webcast, Patient, Coronary thrombosis, Stroke, AKBA, Death, Renal Support Network, Kidney disease, Nephrology, Kidney, Chronic kidney disease, Dialysis, Division, Safety, Stanford University, Food, Hypoxia, FDA, Erythropoietin, Pharmaceutical industry

CAMBRIDGE, Mass., March 27, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo® (vadadustat) Tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia. Vafseo is now approved in 37 countries.

Key Points: 
  • "At Akebia we are committed to kidney patients, a dedication that has driven our team to achieve this milestone.
  • We believe this commitment uniquely positions the company to execute a successful launch designed to drive toward a potential new oral standard of care for dialysis patients."
  • Approximately 500,000 adult patients in the U.S. on dialysis suffer from anemia due to CKD1, which may be associated with many adverse clinical outcomes.
  • Today, most CKD patients are treated for anemia with injectable erythropoiesis-stimulating agents mostly administered at dialysis centers.