Archive for June 2017
FDA Approves Hologic’s Genius™ 3D Exam as Only Superior Mammogram for Dense Breasts
MARLBOROUGH, Mass., June 7, 2017 /PRNewswire/ — Hologic, Inc. (Nasdaq: HOLX) announced today that the Genius™ 3D Mammography™ exam is now the only mammogram that is FDA-approved as superior to standard 2D mammography for routine breast cancer screening of women with dense breasts.1 The Genius exam has been commercially available in the United States since 2011,…
Read MoreNeuromonitoring Company Founded by Former NFL Quarterback Set to Go Public
Assure Holdings, an intraoperative neuromonitoring company founded by former NFL quarterback Preston Parsons, will begin trading on the TSX Venture Exchange on May 29, under the trading symbol IOM. Assure Neuromonitoring, a wholly owned subsidiary of Assure Holdings Inc. (IOM:TSX.V), provides intraoperative neuromonitoring (IONM) services. The standard of care in the United States is to…
Read MoreMove Over Digital Health, the Future is Prepping for Digital Medicine
The future of healthcare is not a device or a drug thus far undiscovered. No, it’s digital and that’s no surprise — but it’s not nearly as simple as today’s digital health. Rather, forward-looking hospitals including Mount Sinai, LifeBridge Health and Thomas Jefferson, in fact, have clinical innovation teams working on digital medicine projects. The…
Read MoreFDA Releases List of Reuseable Medical Devices with Highest Infection Risk
The Food and Drug Administration on Thursday published a list of reusable medical devices that hold the greatest risk of infection transmission or poor performance if not appropriately reprocessed, reports Regulatory Focus. The agency will now require device makers to submit validated instructions for use — along with validation data regarding the cleaning, disinfection,…
Read MoreMan with Two Hearts Survives Heart Attack
At first there didn’t seem to be anything unusual about the man who, in 2010, reported to a Verona, Italy emergency room. He was short of breath, sweating, and had low blood pressure – cardiovascular trouble, no doubt. E.R. doctors see similar symptoms all the time. But this man was very different indeed. He had…
Read MoreNew surgical technique makes prosthetic limbs feel real
MIT researchers have developed a new surgical technique that makes prosthetic limbs feel like real limbs. It could also help reduce the rejection rate of prosthetic limbs. “We’re talking about a dramatic improvement in patient care,” said Hugh Herr, a professor of media arts and sciences and senior author on the study, in a press…
Read MoreFDA Clears Sentinel Cerebral Protection Device from Claret Medical
The US Food and Drug Administration (FDA) has cleared the Sentinel Cerebral Protection System (Claret Medical), a filter device used during transcatheter aortic valve replacement procedures to reduce the risk of stroke caused by embolic debris, the company announced today. The clearance comes after a mostly positive review by the agency’s advisory committee back in…
Read More3D Printed Medical Devices Market Valued at $1469.4 million by 2026
3D printed medical devices are state-of-the-art medical devices that involve a process of developing three-dimensional solid objects from a digital model. Patient specific treatment is the main advantage of 3D printing technology in the healthcare industry. In the domain of healthcare, 3D printing technology is used to develop medical devices such as dental implants, orthopaedic…
Read More3D Printed Stents for Children That Grow With Patient’s Vessels
Sadly, it is not only old people that receive cardiac stent implants. Often young children with certain cardiovascular conditions can benefit significantly from stent implantations and conduits, but because vasculature grows along with the rest of the body, the stents’ benefits can be short lived and not fully realized. Now researchers at Eindhoven University of Technology…
Read More