Pleural effusion

Samsung Introduces Lunit AI Solutions for Enhanced Chest Screenings

Retrieved on: 
Thursday, January 25, 2024

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

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

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

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

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

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

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

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.

U.S. FDA Approves Pfizer’s BRAFTOVI® + MEKTOVI® for BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, October 12, 2023

“Today’s approval builds on our long-standing commitment to deliver innovative, personalized medicines to patients with lung cancer.

Key Points: 
  • “Today’s approval builds on our long-standing commitment to deliver innovative, personalized medicines to patients with lung cancer.
  • “The PHAROS trial demonstrated that these patients could benefit from BRAFTOVI + MEKTOVI targeted therapy regardless of their prior treatment history.
  • BRAFTOVI + MEKTOVI is also FDA-approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
  • BRAFTOVI is FDA-approved, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

Merit Medical Launches the Aspira® Evacuated Drainage Bottle 

Retrieved on: 
Wednesday, September 6, 2023

SOUTH JORDAN, Utah, Sept. 06, 2023 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced U.S. commercial release of its Aspira Bottle.

Key Points: 
  • SOUTH JORDAN, Utah, Sept. 06, 2023 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced U.S. commercial release of its Aspira Bottle.
  • The new evacuated drainage bottle is the latest addition to Merit’s drainage portfolio.
  • The bottle also offers convenience with its ease-of-use and advanced design that requires 23% less storage space than the leading drainage bottle on the market.1 To further optimize patient comfort, the Aspira Bottle allows users to control drainage speed, helping to minimize discomfort and pain associated with high vacuum pressure drainage.
  • “The Aspira Bottle is one more way Merit strives to improve patient care, which includes providing the option of at-home care,” said Fred P. Lampropoulos, Merit Medical’s Chairman and CEO.