Keeping you up to date on recent developments in orthopedics, including: Scientists use nanotechnology to detect bone-healing stem cells; Premia reports FDA breakthrough device designation for Its Tops system; 'Break a leg' not so lucky when it leads to limb deformities.
The Made in America Tax Plan President Joe Biden is proposing to pay for his $2 trillion U.S. American Jobs Plan could change the way multinational drug and device companies do business, as well as curb M&As that take advantage of global tax benefits.
The FDA authorized marketing of the Portable Neuromodulation Stimulator (Pons) for short-term treatment of gait issues arising from mild to moderate symptoms associated with multiple sclerosis (MS) through its de novo pathway. Helius Medical Inc., a subsidiary of Helius Medical Technologies Inc., makes the non-implantable neuromuscular tongue stimulator.
LONDON – Inbrain Neuroelectronics Ltd. has raised €14.35 million (US$16.9 million) in a series A round to take nanoscale graphene implants it says have the potential to interface one-on-one with neurons, into clinical development later this year. The technology promises significant improvements on current implants used for deep brain stimulation to treat conditions including Parkinson’s disease, epilepsy, obsessive compulsive disorder and neuropathic pain.
PERTH, Australia – Ferronova Ltd. has developed an injectable magnetic and fluorescent tracer that can map the spread of cancer in the lymph nodes more accurately for improving the staging of complex cancers. The polymer-coated iron oxide nanoparticles show more detailed assessment of sentinel lymph nodes and detect micro-metastasis and isolated tumor cells that would otherwise not be detected.
Teleradiology company Nines Inc. won 510(k) clearance from the FDA for Ninesmeasure, an artificial intelligence (AI)-powered tool for measuring lung nodules. The Palo Alto, Calif.-based company says the new tool can help speed the diagnosis of certain respiratory diseases, resulting in better patient outcomes.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Endologix, other stent graft products in line for FDA panel safety probe; New conditions imposed on vaccine authorization; MRNA vaccine efficacy holds in real world; STIs on the rise in U.S.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Binx Health, Gold Standard Diagnostics, Nines.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Clearflow, Instylla, Perimeter Medical Imaging AI, Pixium Vision.
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