Medical Imaging

Physicians utilize medical imaging to see inside the body to diagnose and treat patients. This includes computed tomography (CT), magnetic resonance imaging (MRI), X-ray, ultrasound, fluoroscopy, angiography,  and the nuclear imaging modalities of PET and SPECT. 

Cranial stimulator maker, users criticize new FDA proposed rule

Alpha-Stim, a maker of cranial electrotherapy stimulators used to treat anxiety, depression, insomnia and pain, is campaigning against a proposed rule in the FDAs premarket approval (PMA) processand device users are joining the chorus.

AJR: Financial interest spurs imaging utilization

A new analysis verified and strengthened earlier studies that demonstrated the link between financial interest in imaging and greater utilization of imaging. The research, published in the November issue of American Journal of Roentgenology, led the authors to suggest that cost-containment efforts target financial interest in imaging.

FDA clears Ventana's image analysis app for cancer detection

Ventana Medical Systems has been granted 510(k) clearance to go to market with an image analysis application used to detect breast and other types of cancer. The Ventana Companion HER2 (4B5) application assists pathologists with interpretation of images of a certain protein in tissue, according to a company statement.

10 House bills target FDA med device approval process

House Republicans have recently introduced 10 bills that, collectively, aim at increasing the predictability, consistency and transparency of the FDAs medical device review and approval process. Legislators summarized their concerns in an Oct. 14 memorandum sent to the Energy and Commerce Committee, detailing the proposed measures designed to reform the medical device review and approval process.

FDA clears Candelis cloud software

Candelis has received 510(k) clearance from the FDA for its Astra cloud-hosted suite of software services which includes Astra Plus, Astra Lite and Astra Mobile.

Radiology: RF ablation safe treatment for benign thyroid nodules

The complication rates in treating benign thyroid nodules with radiofrequency (RF) ablation are low, though various complications may still occur, warranting preventive measures, according to a study published in the October issue of Radiology.

EMA supports Actos as 'valid treatment' for diabetes

The European Medicines Agency has clarified its opinion on the scrutinized diabetes drug pioglitazone (Actos, Takeda Pharmaceuticals), a drug that received negative media reports earlier this year after it was found that it may increase the risk of cardiovascular events and incidence of bladder cancer.

EMA launches safety review of NSAIDs

After copious amounts of data showed that non-steroidal anti-inflammatory drugs (NSAIDs) may be linked to cardiovascular risk, the European Medicines Agency said that it will launch a review to better understand this potential risk.

Around the web

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

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.

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.