Catch up on a variety of FDA news in radiology from the past week.
|Articles|January 26, 2015
Micro Dose Gets FDA Nod For Pediatric Imaging
Author(s)Diagnostic Imaging Staff
The FDA has cleared Micro Dose by EOS imaging, a low dose option now available on EOS equipment.
Advertisement
EOS imaging received U.S. FDA clearance for Micro Dose, an option now available on EOS equipment that lowers dose of pediatric spine follow-up imaging exams, the company announced.
Micro Dose is designed for pediatric patients with orthopedic conditions that require frequent imaging exams for continuous monitoring of disease progression and treatment, the company said. Initial results presented at RSNA 1014 showed that Micro Dose generates dosage levels equivalent to a week of naturally-occurring background radiation in pediatric patients receiving 2D and 3D follow-up examinations, the company announced.
Micro Dose is in full accordance with the As Low As Reasonably Achievable (ALARA) principle, Marie Meynadier, CEO of EOS imaging, said in a release.
Advertisement
Related to this article
Catch up on the top radiology content of the past week.
Reportedly one of the first FDA-cleared chest X-ray AI software platforms derived from a foundation model, the Chest Xray software facilitates detection and localization of lung nodules, pneumothorax, mediastinal abnormalities and other thoracic abnormalities.
Incorporating structural MRI to improve PET imaging resolution, the MICSI-PET software also offers automated Centiloid quantification from amyloid PET scans.
Emerging research demonstrates the increasing stability of attenuation on clinically relevant VMIs with photon-counting CT and a redefined role of kV that may have implications for longitudinal quantitative CT.
For patients with intermediate-risk prostate cancer, those with lower apparent diffusion coefficient (ADC) values on pre-treatment DWI MRI had a fourfold higher prevalence of distant metastasis in a study with a 10.3-year median follow-up.
In the second of a two-part podcast episode, Lauren Nicola, MD, Christoph Wald, MD, PhD, MBA, and Peter Shen discuss challenges with evaluating value and ROI for AI software, the physician time required to do so, and possible solutions to facilitate improved clarity and consistency with AI reimbursement.
In the latest episode of her “Breast Imaging in Focus” series, Manisha Bahl, MD, MPH, FSBI, offer pertinent takeaways for breast radiologists from recently issued guidelines for addressing proliferative breast lesions with atypia and lobular carcinoma in situ (LCIS).
Advertisement
Advertisement
Trending on Diagnostic Imaging
1
Radiology Roundup of FDA News: September 13 — September 19
2
Does kV Still Matter in Photon-Counting CT?
3
Foundation Model-Based Chest X-Ray AI Software Gets FDA Nod
4
FDA Clears Software That Combines MRI Enhancement of PET Imaging with Automated Quantification of Amyloid and Tau PET
5