FDA Regulation for Combination Products

Apr 26th, 2012

London, H9

GB

http://www.management-forum.co.uk/medical/eventid/1952

Phone:44 1483 730071

This course provides a comprehensive overview of how the FDA handles combination products.

EVT promising in patients with extracranial ICA occlusions

January 21, 2025

Images depict a 49-year-old female participant with cryptogenic cirrhosis who presented with a 3.2-cm liver lesion. This biopsy-confirmed hepatocellular carcinoma (HCC) with an initial categorization of Liver Imaging Reporting and Data System (LI-RADS) category LR-4 (probably HCC) at CT was upgraded to LR-5 (definitely HCC) at contrast-enhanced ultrasound (CEUS). (A) Precontrast CT images in the liver show vague hypoattenuation in the medial left hepatic lobe (arrows). (B) Arterial phase images demonstrate no definite arterial phase hyperenhancement (arrows). (C) Washout and an enhancing capsule (arrows) on a late-phase image resulted in an LR-4 categorization. (D) B-mode ultrasound shows a round hypoechoic nodule (arrows). (E) An early-phase CEUS image shows clear arterial-phase hyperenhancement (arrows); (F) No washout at one minute (arrows), and (G) late, mild washout at four minutes (arrows) resulted in a CEUS LR-5 categorization.

CEUS resolves indeterminate CT, MRI liver observations

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PET/CT can rule out CAV in heart transplant patients

January 17, 2025

Machine learning can predict immunotherapy response in NSCLC patients

January 17, 2025

EVT promising in patients with extracranial ICA occlusions

Endovascular thrombectomy (EVT) and best medical treatment are both effective and safe options for patients with acute extracranial internal carotid artery occlusions.

January 21, 2025

CEUS resolves indeterminate CT, MRI liver observations

By Amerigo Allegretto

Contrast-enhanced ultrasound (CEUS) can resolve some high-risk indeterminate liver observations initially seen on CT or MRI.

January 21, 2025

Images depict a 49-year-old female participant with cryptogenic cirrhosis who presented with a 3.2-cm liver lesion. This biopsy-confirmed hepatocellular carcinoma (HCC) with an initial categorization of Liver Imaging Reporting and Data System (LI-RADS) category LR-4 (probably HCC) at CT was upgraded to LR-5 (definitely HCC) at contrast-enhanced ultrasound (CEUS). (A) Precontrast CT images in the liver show vague hypoattenuation in the medial left hepatic lobe (arrows). (B) Arterial phase images demonstrate no definite arterial phase hyperenhancement (arrows). (C) Washout and an enhancing capsule (arrows) on a late-phase image resulted in an LR-4 categorization. (D) B-mode ultrasound shows a round hypoechoic nodule (arrows). (E) An early-phase CEUS image shows clear arterial-phase hyperenhancement (arrows); (F) No washout at one minute (arrows), and (G) late, mild washout at four minutes (arrows) resulted in a CEUS LR-5 categorization.

PET/CT can rule out CAV in heart transplant patients

Cardiac PET/CT scans can effectively rule out moderate to severe cardiac allograft vasculopathy (CAV) in heart transplant patients.

January 17, 2025

Machine learning can predict immunotherapy response in NSCLC patients

By Kate Madden Yee

Machine learning (ML) can help clinicians predict immunotherapy response in patients with inoperable non-small cell lung cancer (NSCLC).

January 17, 2025

Current topics in mammography

By Sandy Coffta

Sandy Coffta of Healthcare Administrative Partners discusses changes in reporting and reimbursement for mammography exams.

January 17, 2025

Coffta Sandy Thumbnail

Surgeon General's alcohol advisory puts patient counseling at the fore

By Amerigo Allegretto

Patient communication and education may be key for radiologists in the wake of the Surgeon General’s advisory on alcohol-related cancer risk.

January 17, 2025

Wine Red Glass 400

FAPI-PET shows promise for imaging gastric cancers

Gallium-68 fibroblast activation protein inhibitor (FAPI) PET/CT is a promising new method for imaging gastric cancer.

January 16, 2025

Fapi Pet Gastric Cancer Thumbnail

CEM has slightly higher mean glandular dose than DBT, mammography

By Amerigo Allegretto

Contrast-enhanced mammography (CEM) has a slightly higher mean glandular dose than other breast imaging modalities.

January 16, 2025

Contrast Injector

ACS: Cancer mortality continues to drop

By Kate Madden Yee

Cancer mortality rates continue to drop -- although incidence of the disease is rising in women, according to an annual study released by the ACS.

January 16, 2025

Cancer Cell Target2

POCUS useful for diagnosis of retained conception tissue

By Amerigo Allegretto

Point-of-care ultrasound (POCUS) can be a useful tool for diagnosing the presence of retained conception tissue.

January 15, 2025

Ultrasound Portable

Top 5 predictions for the imaging IT and AI markets in 2025

By Amy Thompson

Amy Thompson of Signify Research shares five predictions for the Imaging IT and AI markets in a new column.

January 15, 2025

2025 Trends Concept

Simulated contrast-enhanced MRI helps assess prostate cancer

By Kate Madden Yee

Simulated contrast-enhanced MR images from noncontrast sequences using deep learning show promise for assessing clinically significant prostate cancer.

January 15, 2025

2025 01 14 Radiology Huang Figure5 Thumbnail

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