U.S. FDA Quality Requirements and CAPA for Medical Devices

Dec 9th, 2009Dec 10th, 2009

London, --

GB

https://www.management-forum.co.uk/medical/eventid/844

Further meeting details will be available shortly. Please contact [email protected].

Brain MRI tracks risk of stage IV breast cancer metastases

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Experts call for CPT codes for imaging AI reimbursement

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Is herpes infection protective in early Alzheimer’s disease patients?

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Triple-negative breast cancers impact female populations differently

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Brain MRI tracks risk of stage IV breast cancer metastases

By Kate Madden Yee

Brain MRI shows promise for surveilling women at risk for asymptomatic stage IV breast cancer metastases by tracking molecular subtypes of the disease.

January 24, 2025

Experts call for CPT codes for imaging AI reimbursement

By Amerigo Allegretto

Imaging AI tools and algorithms continue to be rapidly developed, but experts say reimbursement through CPT codes is needed.

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Insurance Computer 400

Is herpes infection protective in early Alzheimer’s disease patients?

In a recent PET study with “unexpected” results, patients infected with herpes had fewer signs of brain deposits associated with Alzheimer’s disease than uninfected patients.

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Triple-negative breast cancers impact female populations differently

By Amerigo Allegretto

Despite overall breast cancer rate increases, women of varying race and ethnicity experience disproportionately higher increases.

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Breast Cancer Cell2 Social

What brain mechanisms drive depression in older adults?

PET has revealed that mechanisms other than amyloid brain deposits may underlie depressive symptoms in people later in life.

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MR spectroscopy reveals neurochemical patterns linked to COVID-19

By Kate Madden Yee

Proton MR spectroscopy (MRS) reveals "remarkable" neurochemical patterns associated with COVID-19-induced anosmia, or loss of smell.

January 23, 2025

LI-RADS ultrasound surveillance version 2024 improves HCC detection

By Amerigo Allegretto

The 2024 version of the LI-RADS Ultrasound Surveillance system improves detection of hepatocellular carcinoma (HCC) over earlier iterations.

January 22, 2025

(A,B) Images from an initial ultrasound examination showed no identifiable lesions and received a consensus ultrasound category of US-1. Nearly the entire liver is visualized, with minimal shadowing (“s”, A and B), and the examination received consensus result of VIS-A. The AFP level was 7.1 ng/mL on assessment six months before the ultrasound, 9.1 ng/mL on assessment three months before examination, and 14.2 ng/mL on assessment on exam day. The AFP result was thus assessed as positive based on a progressive increase on two consecutive tests. The atient was considered to have negative surveillance result according to LI-RADS Ultrasound Surveillance v2017, but positive surveillance result according to LI-RADS Ultrasound Surveillance v2024. (C-D) Axial arterial-phase (C) and portal-venous phase (D) T1-weighted images from subsequent gadoxetic acid-enhanced MRI show a 2-cm arterial-phase hyperenhancing observation (arrow, C) with portal-venous washout (arrow, D) in segment 7. This observation was classified on MRI as LR-5, thus meeting the present study’s reference standard for diagnosis of HCC. The mass is located in the periphery of the liver, an anatomic area where ultrasound visualization can be challenging due to shadowing.

Deep learning helps find, segment lung tumors on CT imaging

By Kate Madden Yee

Using a deep-learning model with lung CT imaging shows promise for identifying and segmenting tumors, researchers have reported.

January 22, 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

Images in a 74-year-old male patient who presented at the hospital with acute symptoms of a right hemispheric ischemic stroke and a National Institutes of Health Stroke Scale (NIHSS) score of 24. (A) Nonenhanced CT image shows no signs of early infarction, whereas (B) CT perfusion image shows a large perfusion deficit in the territory of the middle cerebral artery and anterior cerebral artery caused by an extracranial occlusion in the right internal carotid artery. (C) Digital subtraction angiography shows the occlusion in the C1 segment. The extracranial occlusion was passed, reperfused, and subsequently stented (D, E). The final contrast injection did not reveal any intracranial occlusions within the territory of the internal carotid artery (F). At the 24-hour follow-up, there was no infarction on (G) the nonenhanced CT image, and the NIHSS score had decreased to 3 points. Image courtesy of RSNA.

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

January 17, 2025

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