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. Read More
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. Read More
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. Read More
The latest salvo in the debate over patents protecting COVID-19-related drugs, devices and vaccines came this week from U.S. industry organizations, including Advamed, the Biotechnology Innovation Organization and the Pharmaceutical Research and Manufacturers of America. Read More
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. Read More
New hires and promotions in the med-tech industry, including: Aavantibio, Advanced Sterilization Products, Ceryx Medical, Dnanexus, Flatiron Health, Fortive, Paige, Rebus Biosystems, Renovacare, Zillion. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Clearflow, Instylla, Perimeter Medical Imaging AI, Pixium Vision. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Binx Health, Gold Standard Diagnostics, Nines. Read More
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. Read More
Keeping you up to date on recent developments in oncology, including: NCI team devises method to recruit myeloid cells in pushback against cancer; Algorithm ranks cancer therapies for efficacy; New twist on quantum dots could revolutionize imaging. Read More