Drug/Device and Device/Drug Combinations in the EU and USA

Apr 18th, 2018Apr 19th, 2018
London, 17
GB
https://management-forum.co.uk/product/details/2035?referrer=lwmay17
Phone:2077494730
This seminar will provide practical advice on the borderline issues concerning these combination products and provide key guidance on the regulatory strategy to follow.
Latest in Home
Radiation Logo
New benchmark helps monitor cumulative CT radiation dose
February 13, 2026
2026 02 13 Port Fractures Thumbnail
Study questions routine use of radiotherapy after bone surgery
February 13, 2026
2026 02 12 Wfumb Sertic Ceus Kidney Lesions Thumbnail
CEUS outshines color Doppler imaging for indeterminate kidney lesions
February 13, 2026
Minnie Cast Thumbnail (1) 1
Women's Imaging MinnieCast, Episode 2: Risk-based vs. annual mammography screening, part 1
February 13, 2026
More in Home
New benchmark helps monitor cumulative CT radiation dose
By Kate Madden Yee
The findings highlight the need for systematic dose tracking and rigorous justification of imaging.
February 13, 2026
Radiation Logo
Study questions routine use of radiotherapy after bone surgery
By Will Morton
Findings suggest a possible hazard associated with postoperative radiotherapy.
February 13, 2026
2026 02 13 Port Fractures Thumbnail
CEUS outshines color Doppler imaging for indeterminate kidney lesions
By Amerigo Allegretto
CEUS outperformed color Doppler ultrasound in a study focusing on indeterminate kidney lesions.
February 13, 2026
2026 02 12 Wfumb Sertic Ceus Kidney Lesions Thumbnail
Women's Imaging MinnieCast, Episode 2: Risk-based vs. annual mammography screening, part 1
By Amerigo Allegretto
Vilert Loving, MD, from Ochsner Health and the SBI discusses breast cancer screening based on annual mammography versus risk.
February 13, 2026
Minnie Cast Thumbnail (1) 1
Chest x-rays reveal atherosclerosis in patients undergoing amputations
By Will Morton
Lower limb amputation is an increasingly common major complication of advanced peripheral arterial disease and diabetes mellitus.
February 12, 2026
2026 02 12 Chest Ac2 Thumbnail
3D MRI technique helps plan treatment for pediatric heart conditions
By Kate Madden Yee
The method makes "heart muscle and heart valves visible while making blood and surrounding tissues transparent," researchers noted.
February 12, 2026
Cardiac Mri Adobe Samunella
Could AI scoring help with managing DCIS?
By Amerigo Allegretto
An AI model showed associations with recurrence after DCIS surgery and performed comparably to established clinical risk models.
February 11, 2026
Images of a 39-year-old who underwent screening mammography. Right craniocaudal (left) and mediolateral oblique (middle) views from preoperative mammography show suspicious grouped fine pleomorphic calcifications (arrows). After biopsy showed ductal carcinoma of situ (DCIS), patient underwent breast-conserving surgery, yielding final diagnosis of ductal carcinoma in situ (intermediate grade, hormone receptor positive). (Right) Screenshot of an output of a commercial AI tool applied to preoperative mammography. AI detected right breast lesion with score of 95% on both views (concentric colored circles). Present study’s reviewing radiologist deemed AI marking to correspond with site of DCIS.
Clinicians, beware: CT diagnostic accuracy varies by adnexal lesion type
By Kate Madden Yee
The modality correctly diagnoses dermoids and simple cysts, but is not as effective at identifying other types of adnexal lesions.
February 11, 2026
Axial contrast-enhanced CT scan in a 28-year-old premenopausal woman shows an incidentally detected solid-appearing left ovarian lesion (solid arrow) anterior to the uterus (U), associated with trace ascites in the right adnexa and cul de sac (dashed arrows). At pathologic analysis, this was shown to be ovarian dysgerminoma. Two readers misdiagnosed this lesion, one as a leiomyoma and one as an ovarian fibroma.
Radiology coding update for 2026
By Erin Stephens
In a new column, Erin Stephens of Healthcare Administrative Partners reviews the 2026 CPT code changes.
February 11, 2026
Erin Stephens
Super-resolution deep learning reconstruction improves CCTA
By Will Morton
The commercially available image reconstruction algorithm outperformed standard hybrid iterative reconstruction for assessing coronary stenosis.
February 10, 2026
Images from two representative cases. (A-C) Images in an 82-year-old man with a calcified plaque in the proximal segment of the left anterior descending artery. (A, B) Curved planar reconstruction images from CCTA with (A) hybrid iterative reconstruction (HIR) and (B) super-resolution deep learning reconstruction (SR-DLR) show that the measured PDS was 66% for the HIR image and 42% for the SR-DLR image. (C) Quantitative analysis of the invasive coronary angiography (ICA) image (reference standard) revealed a PDS of 34% (arrow). (D-F) Images in a 37-year-old woman with a noncalcified plaque in the middle segment of the left circumflex artery. (D, E) Curved planar reconstruction images from CCTA with (D) HIR and (E) SR-DLR show that the measured PDS was 47% for the HIR image and 80% for the SR-DLR image. (F) Quantitative analysis of the ICA image revealed a PDS of 72% (arrow). Blue, red, and yellow lines in A, B, D, and E represent the proximal reference point, stenosed lesion, and distal reference point, respectively, and the insets show the corresponding cross-sectional images.
Nonsurgical management rising for low-risk DCIS cases
By Amerigo Allegretto
Trends show that nonsurgical management of DCIS is rising, paving the way for imaging's role in active surveillance.
February 10, 2026
Breast Mammo 400
Gadoxetate MRI offers high sensitivity for liver cancer screening
By Kate Madden Yee
"Most participants undergoing HCC screening had excellent MRI quality even when ultrasound was limited," researchers noted.
February 10, 2026
2026 02 10 Radiology Lewis Figure2 Thumbnail
Page 1 of 202
Next Page