Tag:

MRI

Latest Headlines

Latest Headlines

St. Jude gets FDA approval for tiniest MRI-compatible, upgradeable, spinal-cord pain neurostimulator

The FDA has approved the Protégé MRI spinal cord stimulation system to treat chronic pain, along with the related MRI compatible leads, from St. Jude Medical. The device also offers the benefit of enabling future updates via wireless software upgrades rather than requiring its replacement to gain the benefits of new developments.

Tal Medical gets $14M to sort out dosage, durability for fast-acting depression device

Tal Medical has its roots in the serendipitous discovery that MRI imaging has a fast, mood-elevating effect. So far, it's managed to establish in the clinic that its low-field magnetic stimulation device built to recreate those conditions is rapid-acting. But now it's raised a $14 million Series B round to help establish the durability of that effect and the best dosage for depression treatment.

UPDATED: Nearly 10,000 GE, Siemens MRI machines under FDA recall

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."

Mayo Clinic finds a common MRI contrast agent is deposited in the brain

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.

Studies show need to supplement mammography with MRI, ultrasound for dense breast tissue

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.

UPDATED: GE recalls 10,000+ MRI systems after FDA deems them potentially deadly, citing poor training

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."

UPDATED: NIH launches crowdsourcing challenge to commercialize its neurological medical devices

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.

FDA issues new guidance on MRI safety and compatibility of medical devices

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.

JAMA study: Cochlear implants can cause pain during MRIs

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 raises $40M to support next-generation infusion pump with improved MRI compatibility

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.