Augmedics Inc., a Chicago-based startup focused on augmented reality (AR) applications in health care, has scored a 510(k) clearance from the U.S. FDA for its Xvision Spine system. The company launched the device, which provides surgeons with X-ray quality insights into a patient’s anatomy and real-time surgical navigation, on Monday, with distribution slated to begin in the new year. While the FDA has cleared other AR products, Xvision Spine (XVS) is the first to be indicated for guided surgery. Read More
The exclusion of makers of devices and drugs from a proposed overhaul of the Anti-Kickback Statute (AKS) probably took many in industry by surprise, but Premier Inc., of Charlotte, N.C., argued that this approach fails to capitalize on an opportunity to hold manufacturers accountable for clinical outcomes in value-based arrangements. Read More
TORONTO – Imagin Medical Inc., which has a presence near Boston and in Vancouver, British Columbia, will have verified and built a device in early January that meets all functional, electrical safety and radiated emission requirements for a new way of visualizing bladder cancer. Jim Hutchens, Imagin Medical’s president and CEO, said the i/blue imaging system should dramatically improve surgeons’ ability to visualize cancerous bladder cells by producing higher quality images more quickly compared with current methods. Read More
Researchers at Duke University have developed a bandage that concentrates adenosine at the site of a fracture and speeds bone repair. In animal testing, the bandage accelerated bone healing by 20% to 25%, lead researcher Shyni Varghese told BioWorld MedTech. Read More
Following lengthy consultations with industry, Australia’s Therapeutic Goods Administration (TGA) has released its new regulatory framework for in vitro companion diagnostics (IVD CDx) that becomes effective in February. Read More
The much-maligned medical device tax was finally laid to rest Dec. 20, as President Donald Trump signed a spending bill that included a permanent repeal of the tax. The 2.3% excise tax on devices was brought into the statute via the Affordable Care Act (ACA), and its repeal brings much-needed breathing room to small device makers. Read More
