FDA clears Philips' full-field digital mammo system

Editorial Staff | | Health Imaging | Diagnostic Imaging

Royal Philips Electronics has received 510(k) clearance from the FDA for its MicroDose SI system, a full-field digital mammography (FFDM) system with the capability to enable future Single-Shot Spectral Imaging applications (which is not available in North America).

Philips is working on future software applications like Spectral Breast Density Measurement, which will build upon the MicroDose SI technology. Spectral Breast Density Measurement also is not available in North America.

As in existing Philips MicroDose systems, the MicroDose SI uses digital photon-counting technology. Philips has upgraded this technology with Single-Shot Spectral Imaging, which is built upon the fact that breast density is subject to different tissue types and materials that absorb x-rays at various energies, according to the company.
 

Editorial Staff

Related Content

AI rules out abnormal findings on chest X-rays, significantly reducing workloads
Older adults among the walking wounded with incident TBI
Philips moves digital pathology to the cloud with AWS
PHOTO GALLERY: What does fetal medical imaging look like?
Speaker laments radiology’s major contribution to climate change
Radiologist accuracy takes a hit overnight, especially with advanced imaging exams

Around the web

Radiology Business
The biggest obstacles facing radiology business managers in 2025

RBMA President Peter Moffatt discusses declining reimbursement rates, recruiting challenges and the role of artificial intelligence in transforming the industry.

Cardiovascular Business
New cardiac prevention paradigm explored in TRANSFORM trial using AI and CCTA

Deepak Bhatt, MD, director of the Mount Sinai Fuster Heart Hospital and principal investigator of the TRANSFORM trial, explains an emerging technique for cardiac screening: combining coronary CT angiography with artificial intelligence for plaque analysis to create an approach similar to mammography.

Cardiovascular Business
Cardiology practices pay $17.7M to settle fraud allegations brought on by whistleblowers

A total of 16 cardiology practices from 12 states settled with the DOJ to resolve allegations they overbilled Medicare for imaging agents used to diagnose cardiovascular disease.