Recent advances in biomarkers and imaging capabilities have improved the diagnosis of Alzheimer’s disease (AD). Fujirebio Diagnostics Inc. aims to further expand the arsenal of AD diagnostics with its Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test. On Wednesday, the company said it had filed a 510(k) submission with the U.S. FDA for premarket clearance of the Lumipulse G β-Amyloid IVD. Read More
Bluestar Genomics Inc. and the University of Chicago revealed the publication of a genome-wide 5-hydroxymethylcytosine (5hmC) map across multiple human tissue types. In the report, published Dec. 2, 2020, in Nature Communications, the researchers detailed the development of the map by characterizing the genomic distributions of 5hmC in 19 human tissues derived from 10 organ systems. Read More
The U.S. Centers for Medicare & Medicaid Services (CMS) has posted the Medicare physician fee schedule for calendar year 2021, a document that has drawn blistering reviews from a number of stakeholders. The criticisms generally revolve around the impact of higher rates for evaluation and management (E&M) services on other rates, but there is already legislation in play on Capitol Hill that would reverse the changes wrought by increases in rates for E&M services. Read More
With hospitalizations rapidly rising as the COVID-19 pandemic washes across the world in a winter wave, researchers are racing to develop treatments that protect the increasing number of ventilated patients. One option focuses on protecting muscles critical to breathing. Read More
PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) has unveiled its final regulatory requirements for personalized medical devices, including 3D-printed devices, that go into effect on Feb. 25, 2021. Under the previous framework, custom-made medical devices were exempt from the requirement to be included in the Australian Register of Therapeutic Goods (ARTG). Read More
CAJICA, Colombia – Chembio Diagnostic Systems Inc., a point-of-care diagnostic company focused on infectious diseases, received the approval from Anvisa, the Brazilian health care surveillance agency, to distribute its tests in the Latin American market. The approval adds yet another test to the hundreds already approved in Brazil, where the market for such tests is quickly getting crowded sending prices down. Brazil is one of the countries most affected by COVID-19 with almost 6 million cases and 166,000 deaths, the third highest number of cases in the world. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA slaps two companies for illicit COVID offerings; FDA approves new PET imaging agent for prostate cancer. Read More
New hires and promotions in the med-tech industry, including: Alchemy 43, American College of Cardiology, Carterra, Deep Lens, N2 Biomedical, Proprio, V-Wave. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Etiometry, Modulim, Nico.Lab, Roche, University of California. Read More
Keeping you up to date on recent developments in orthopedics, including: Researchers develop new biomaterial that helps bones heal faster; Obesity increases the risk of early hip fracture in postmenopausal women; Vitamin D regulates calcium in intestine differently than previously thought. Read More
