Medtronic reports early pivotal data for tiny leadless pacemaker with U.S. launch slated in a year or so
Cardiac Rhythm & Heart Failure is one of Medtronic's faster growing businesses, driven in part by the launch of tiny subcutaneous heart monitor Reveal Linq. The medical device giant expects that the launch of supersmall leadless pacemaker Micra Transcatheter Pacing System could help it to keep that revenue growth momentum going.
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 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.
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.
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."
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.