Almost 10,000 GE and Siemens MRI machines are being recalled, FDA's database shows. The agency classified the recalls in its second-most severe category, meaning the affected machines "may cause temporary or medically reversible adverse health consequences."
The Mayo Clinic has found that gadolinium-based contrast agents used in MRI exams leave deposits in the brain. The researchers said that there is no evidence that the gadolinium deposits are harmful to patients and continues to recommend the use of gadolinium-based contrast agents as appropriate.
Women with dense breasts are more likely to have so-called mammographically occult breast cancer, meaning the disease won't be detected using a conventional mammogram, data presented at the San Antonio Breast Cancer Symposium showed.
The FDA just deemed all GE Healthcare MRIs with superconducting magnets potentially deadly by classifying the recall of nearly 13,000 of the imaging systems into the most serious Class I category. This means there is a reasonable probability that the device "will cause serious adverse health consequences or death."
The National Institutes of Health is launching The Neuro Startup Challenge, a crowdsourcing competition featuring 72 teams from 80 hospitals and universities, with a goal of commercializing 16 of its neuroscience inventions, including enhancements to MRI machines.
The FDA just issued new guidance on the MRI compatibility--or in some cases incompatibility--of implants that do not require electrical power to service their function, such as cardiovascular stents, intracranial aneurysm clips, endovascular grafts and transprostatic tissue retractors.
Some patients with cochlear implants feel pain during an MRI that is strong enough to prevent them from completing the procedure, a recent study in the Journal of the American Medical Association shows.
Flowonix, maker of the implantable Prometra infusion pump for chronic pain patients, announced that it has raised $40 million in debt and equity financing led by private equity fund Élevage Capital Management.
President Obama's trip to China was a productive one. Not to be overshadowed by the countries' new climate change accord is an agreement to expand the World Trade Organization's tariff-cutting Information Technology Agreement, to include a host of new products, including medical devices.
Pending FDA approval, the upgraded Prometra Implantable Pump System for targeted drug delivery of pain medication will feature MRI compatibility, Flowonix CEO Steve Adler told FierceDrugDelivery in an interview.