A biomarker found in spinal fluid can detect Parkinson’s disease in individuals with the disease and may flag those at risk years before symptoms develop, a study published in The Lancet Neurology found. The breakthrough, which could enable diagnosis of the disease for the first time in patients who do not exhibit a movement disorder, was achieved by an international coalition of scientists led by the Michael J. Fox Foundation (MJFF) as part of its landmark clinical study, the Parkinson’s Progression Markers Initiative (PPMI). Read More
Medicare coverage of medical devices in the U.S. sometimes is limited to a coverage with evidence development (CED) study, a process that may soon become more stringent. A recent advisory hearing on the CED process suggests that significant changes may be in the making, including a requirement that CED studies more closely reflect the demographic diversity of Medicare beneficiaries at large, a mandate that may force device makers to apply more resources to ensure that CED study enrollments fulfill that mandate. Read More
Neuromod Devices Ltd. will use the €30 million (US$ 32.78 million) financing it recently raised to launch its tinnitus treatment device, Lenire, in the U.S. where there are an estimated 50 million Americans suffering from tinnitus, CEO, Ross O’Neill, told BioWorld. “To get this financing closed is very exciting as we go into the U.S. market which is the biggest hearing market in the world,” he added. Read More
The U.S. FDA has cleared Aroa Biosurgery Ltd.’s 510(k) for its Enivo pump and catheter, which are key components of the company’s new Enivo tissue apposition platform. The device applies negative pressure to a surgical site, helping to reduce fluid accumulation following surgery. It has been cleared for use in removing surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery or other general surgeries where large flaps are formed. Read More
New York-based Apos Medical Assets Ltd., doing business as Aposhealth, has been developing a shoe that provides some relief from pain and disability in patients who are candidates for total knee arthroplasty (TKA), and the Apos shoe seems to have gained a toehold in the U.K. market. The National Institute for Health and Care Excellence (NICE) has provided a guarded recommendation for the use of the Apos shoe in the U.K., although the agency still has questions as to how long use of the shoe can delay the need for TKA. Read More
New hires and promotions in the med-tech industry, including: Endogastric Solutions, Icad, ITM Isotope Technologies, LivaNova, Precision Optics. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott Laboratories, Bio-Techne, Bracco Imaging, Dexcom, Excellus Communications, Fresenius, Livecare, Lunaphore, Quest Diagnostics, Radiopharm, Sonothera, Terthera. Read More
