Pleural effusion

Aileron Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, April 15, 2024
Sale, Idiopathic pulmonary fibrosis, Weill Cornell Medicine, University, Internal, Research and development, Epithelium, Investment, Fibroblast, Interstitial, Pleural effusion, IPF, LPE, Intensive care medicine, Administration, University of Giessen, University of Alabama, Patient, Acquisition, Fibrosis, Associate, Series, Therapy, G&A, Critical Care Medicine (journal), ALRN, Pharmaceutical industry

AUSTIN, Texas, April 15, 2024 (GLOBE NEWSWIRE) -- Aileron Therapeutics, Inc. (“Aileron”, the “Company”, “we”, “our” or “us”) (NASDAQ: ALRN), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update.

Key Points: 
  • We expect to report topline results from the ongoing Phase 1b study of LTI-03 in the third quarter of this year.
  • Net Loss: Net loss for the quarter ended December 31, 2023, was $7.3 million, compared to $4.5 million for the quarter ended December 31, 2022.
  • The basic and diluted net loss per share for the quarter ended December 31, 2023 was $1.54 compared to $1.00 for the quarter ended December 31, 2022.
  • The basic and diluted net loss per share for the full-year 2023 was $3.42 compared to $6.02 for the full-year 2022.

ENHERTU® Approved in the U.S. as First Tumor Agnostic HER2 Directed Therapy for Previously Treated Patients with Metastatic HER2 Positive Solid Tumors

Retrieved on: 
Saturday, April 6, 2024
Research, Women, FDA, Clinical Trials, Biotechnology, Pharmaceutical, Consumer, Health, Science, Oncology, Orbis, Urinary tract infection, Cardiac arrest, Stomatitis, Patient, Stroke, Lung cancer, University, Acute kidney injury, Neoplasm, Therapy, Anemia, Vomiting, Pleural effusion, Cellulitis, Shock (mechanics), Periodic breathing, Colorectal cancer, Abdominal pain, Safety, Immunohistochemistry, Fatigue, ADC, Daiichi Sankyo, Food, IHC, Sepsis, NSCLC, Appetite, Biliary tract, Constipation, NCCN, MD, Priority review, Fatality, Pneumonitis, HER2, ILD, Medication, Pneumonia, AstraZeneca, COVID-19, Biomarker, Diarrhea, Bleeding, MD Anderson Cancer Center, Nausea, Upper respiratory tract infection, Pharmaceutical industry

The first tumor agnostic approval of a HER2 directed therapy and ADC was based on efficacy data in 192 adult patients with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors who were enrolled in one of three multicenter phase 2 trials from the DESTINY clinical development program, including DESTINY-PanTumor02 , DESTINY-Lung01 or DESTINY-CRC02 .

Key Points: 
  • The first tumor agnostic approval of a HER2 directed therapy and ADC was based on efficacy data in 192 adult patients with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors who were enrolled in one of three multicenter phase 2 trials from the DESTINY clinical development program, including DESTINY-PanTumor02 , DESTINY-Lung01 or DESTINY-CRC02 .
  • In DESTINY-PanTumor02, efficacy was assessed in a subgroup of previously treated patients (n=111) with centrally or locally assessed HER2 positive (IHC 3+) solid tumors including either biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumors.
  • In DESTINY-Lung01, efficacy was assessed in a subgroup of patients (n=17) with centrally confirmed HER2 positive (IHC 3+) non-small cell lung cancer (NSCLC).
  • In DESTINY-CRC02, efficacy was assessed in the subgroup of patients (n=64) with centrally confirmed HER2 positive (IHC 3+) colorectal cancer.

Samsung Introduces Lunit AI Solutions for Enhanced Chest Screenings

Retrieved on: 
Thursday, January 25, 2024
Mobile, Wireless, Technology, Medical Devices, Health Technology, Software, Audio, Video, Biotechnology, Health, Oncology, Artificial Intelligence, Digital radiography, Artificial intelligence, Pleural effusion, Calcification, Patient, X-ray, Fibrosis, Pneumoperitoneum, Multimedia, Tuberculosis, Radiology, Radiography, AI, Samsung, Triage, Investment, Vision, Pneumothorax, FDA, Computer-aided, Therapy, Human, Atelectasis, Cardiomegaly, Medical imaging

View the full release here: https://www.businesswire.com/news/home/20240125366766/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240125366766/en/
    GM85 and GC85A Vision digital radiology devices will now be equipped with AI-powered software for chest screenings (Photo: Business Wire)
    The Lunit INSIGHT CXR, an AI-powered chest X-ray analysis solution, and Lunit Insight CXR Triage, an FDA 510(k)-cleared AI triage solution for critical chest findings, will enable Samsung’s CAD (Computer Aided Detection) AI to help radiologists manage the unprecedented volume of patient exams by prioritizing those with suspected abnormalities.
  • By partnering with Lunit, our Samsung digital radiology products will now have computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of suspected pleural effusion or pneumothorax.
  • “With innovation as its cornerstone, Samsung continues to drive solutions to provide excellent patient experiences, simplify technologist workflows and aid in faster diagnosis.
  • Samsung will offer the upgraded systems to North America and European markets and to the Middle East, South America and Southeast Asia.

Lunit AI Solutions to Power Samsung's X-ray Devices for Advanced Chest Screening

Retrieved on: 
Tuesday, January 16, 2024
Pleural effusion, PACS, ERS, Pneumonia, Partnership, System, AI, Lung cancer, Samsung, Triage, Software, Electronics, Samsung Electronics, Intensive care medicine, Pneumothorax, FDA, Therapy, Image, Intensive care unit, Medical imaging

The collaboration centers around the integration of Lunit's AI technology into Samsung's premium X-ray devices, elevating the accuracy and speed of chest screening.

Key Points: 
  • The collaboration centers around the integration of Lunit's AI technology into Samsung's premium X-ray devices, elevating the accuracy and speed of chest screening.
  • Under the terms of the contract, Lunit will supply Samsung Electronics with two AI-powered chest screening solutions: Lunit INSIGHT CXR and Lunit INSIGHT CXR Triage.
  • The initial phase of this collaboration will see the X-ray devices, enhanced with Lunit's AI solutions, targeting the markets in the US, Canada, and Europe.
  • Lunit INSIGHT CXR Triage is an FDA-cleared AI solution that identifies pre-specified critical findings, such as pleural effusion or pneumothorax, on frontal chest X-ray images.

Laborie Introduces the Next Generation RenovaRP Centesis System

Retrieved on: 
Monday, January 8, 2024
Ascites, Abdomen, Patient, System, Paracentesis, Pleural effusion, Health, Thoracentesis, Medical device

PORTSMOUTH, N.H., Jan. 8, 2024 /PRNewswire/ -- Laborie Medical Technologies, Inc. (Laborie), a leading diagnostic and therapeutic medical technology company, is proud to announce the launch of the RenovaRP™ Centesis System, an innovative fluid drainage device designed to advance patient care and improve efficiency for healthcare professionals.

Key Points: 
  • PORTSMOUTH, N.H., Jan. 8, 2024 /PRNewswire/ -- Laborie Medical Technologies, Inc. (Laborie), a leading diagnostic and therapeutic medical technology company, is proud to announce the launch of the RenovaRP™ Centesis System, an innovative fluid drainage device designed to advance patient care and improve efficiency for healthcare professionals.
  • The RenovaRP Centesis System builds upon the current RenovaRP paracentesis pump by providing an expanded indication for thoracentesis and design enhancements to the handle and nest of the device to improve the overall user experience.
  • "The RenovaRP Centesis System represents a significant milestone for Laborie, empowering healthcare professionals with a cutting-edge tool to enhance patient care during paracentesis and thoracentesis procedures," said Rhett Klein, Vice President of Sales and Global Marketing at Laborie.
  • The RenovaRP Centesis System offers a safe, efficient, and minimally invasive solution to address these medical conditions, improving patient comfort and reducing recovery times.

Human medicines European public assessment report (EPAR): Columvi, glofitamab, Date of authorisation: 07/07/2023, Revision: 1, Status: Authorised

Retrieved on: 
Friday, January 5, 2024
Patient, Medical Subject Headings, Marketing, Febrile neutropenia, Agency, INN, Fever, Immune system, Risk, Infection, Diffusion, Allergy, DLBCL, ATC, Bone marrow, Cytokine release syndrome, CD20, Platelet, International, Headache, Disease, Neutropenia, Blood, Language, Pleural effusion, Cancer, B-cell lymphoma, Thrombocytopenia, Neutrophil, Rituximab, COVID-19, European Medicines Agency, Select, Bacteria, Anatomy, Anemia, IIA, Sepsis, CD3, Rash, Medical device

Human medicines European public assessment report (EPAR): Columvi, glofitamab, Date of authorisation: 07/07/2023, Revision: 1, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Columvi, glofitamab, Date of authorisation: 07/07/2023, Revision: 1, Status: Authorised

FDA Approves Merck’s WELIREG® (belzutifan) for the Treatment of Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF-TKI

Retrieved on: 
Friday, December 15, 2023
Biotechnology, General Health, FDA, Health, Pharmaceutical, MSD, Medicine, DSM-IV codes, PD-L1, NYSE, Potassium, Food, Progression-free survival, RECIST, Merck & Co., Head, Pneumonia, Blood transfusion, Dana–Farber Cancer Institute, Risk, Lymphocyte, Hypoxia, Everolimus, Bleeding, IMDC, Fatigue, Sepsis, Patient, Pregnancy, PFS, Effectiveness, Belzutifan, Week, VHL, VEGF, RCC, COVID-19, PD-1, Creatinine, TKI, ORR, Harvard Medical School, Death, Anemia, Fatal, Sodium, Hospital, Pleural effusion, HIV disease progression rates, MRK, Pharmaceutical industry, Birth control, Merck

Also, WELIREG showed an objective response rate (ORR) of 22% (n=82) (95% CI, 18-27) versus 4% (n=13) (95% CI, 2-6) for everolimus.

Key Points: 
  • Also, WELIREG showed an objective response rate (ORR) of 22% (n=82) (95% CI, 18-27) versus 4% (n=13) (95% CI, 2-6) for everolimus.
  • Patients could have received up to three prior treatment regimens and were required to have measurable disease per RECIST v1.1.
  • Dose reductions of WELIREG due to an adverse reaction occurred in 13% of patients.
  • Adverse reactions that required dose reduction in ≥1% of patients were hypoxia (5%) and anemia (3.2%).

Bering Secures FDA Clearance for AI-Based Chest X-Ray Triage Solution

Retrieved on: 
Wednesday, December 6, 2023
Research, Pneumothorax, Food, Patient safety, US Foods, CXR, Algorithm, FDA, Food and Drug Administration, AI, Pleural effusion, Triage, Medical device, Medical imaging, ROC

FDA 510(k) clearance for AI Radiology software product, targeting emergency cases found on chest X-Rays.

Key Points: 
  • FDA 510(k) clearance for AI Radiology software product, targeting emergency cases found on chest X-Rays.
  • Bering to accelerate business in the US market, leveraging new and existing partnerships
    LONDON, Dec. 6, 2023 /PRNewswire/ -- Bering Limited, a London-based medical AI company, today announced it received US Food and Drug Administration (FDA) 510(k) clearance for its AI-powered chest X-Ray triage solution, 'BraveCX'.
  • With the FDA clearance, the company is now able to commercially provide the AI solution to medical professionals and healthcare institutions in the US.
  • FDA clearance means BraveCX prioritises patient safety, whilst still delivering the most advanced Risk Stratification algorithms where they are needed the most."

Bearpac Medical Announces Peritoneal Indication for the Passio Pump Drainage System

Retrieved on: 
Wednesday, December 6, 2023
Ascites, FDA, Patient, Drainage, Pleural effusion, Medical device, Passion (music)

MOULTONBOROUGH, N.H., Dec. 6, 2023 /PRNewswire/ -- Bearpac Medical, LLC is pleased to announce that the FDA has granted 510(k) clearance for the Passio Pump Drainage System for the additional indication of peritoneal to provide therapy for malignant ascites in addition to recurrent pleural effusions.

Key Points: 
  • MOULTONBOROUGH, N.H., Dec. 6, 2023 /PRNewswire/ -- Bearpac Medical, LLC is pleased to announce that the FDA has granted 510(k) clearance for the Passio Pump Drainage System for the additional indication of peritoneal to provide therapy for malignant ascites in addition to recurrent pleural effusions.
  • The Passio Pump Drainage System consists of the Passio Catheter, a Handheld Control Unit (pump) and a Disposable Collection Kit, which includes a redressing kit, for drainage of recurrent and symptomatic malignant ascites as well as recurrent and symptomatic pleural effusions.
  • The Passio pump is attached to an implanted Passio catheter using the disposable collection kit and is activated to begin the evacuation of fluid into the collection bag.
  • The Passio catheter is exclusively designed for use with the Passio collection system.

Pleural Dynamics Receives FDA 510(k) Clearance for its Novel ACES™ Automatic Continuous Effusion Shunt System

Retrieved on: 
Thursday, October 19, 2023
FDA, Health, Medical Devices, Pleurodesis, Critical Care Medicine (journal), Pleural cavity, Pleural effusion, Interventional radiology, Drainage, Abdomen, Patient, Food and Drug Administration, Food, Hospital, Medical device

Pleural Dynamics, a medical device company that is building solutions for chronic, recurrent fluid collections in the body, today announced that the Company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ACES™ Automatic Continuous Effusion Shunt System.

Key Points: 
  • Pleural Dynamics, a medical device company that is building solutions for chronic, recurrent fluid collections in the body, today announced that the Company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ACES™ Automatic Continuous Effusion Shunt System.
  • Pleural Dynamics’ patented ACES™ System addresses these shortcomings1 with its’ one-piece, fully implanted system that can be placed during a short hospital stay.
  • With this FDA 510(k) clearance, Pleural Dynamics will begin real-world clinical use of the ACES™ System with select hospitals and health systems.
  • Pleural Dynamics’ latest technology will play a vital role in improving the lives of patients with intractable pleural effusion.