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Cybersecurity relates closely to both design controls and risk management in the medical device arena. So, any efforts to address cybersecurity must be incorporated into existing design and development planning, as well as overall risk management practices. That means that companies cannot simply stick an authentication algorithm or other Band-Aid on their connected device and be in compliance with regulations. Read More
Swiss neurodevicemaker MindMaze and Mount Sinai Health System, a New York City-based academic medical system, have teamed to develop an at-home digital neurotherapeutic therapy program for acute and long-term recovery from a stroke or concussion. Read More
Neurotech Pharmaceuticals has announced positive phase 3 topline results from two trials evaluating its NT-501 eye implant for patients with macular telangiectasia type 2 (MacTel), which makes the results the first to show preservation of photoreceptors with a novel ophthalmic neuroprotectant therapy, according to the company. Read More
The Medical Device Innovation Consortium (MDIC) has published a new step-by-step framework approach to integrating patient preferences into medical device clinical trials. Read More
The device features a spectral sensor that continuously adjusts light intensity to compensate for higher light absorption levels in darker skin tones. Read More
BioIntellisense announced the launch of its FDA-approved pulse oximetry device, an optical sensor the company says accurately measures blood oxygen levels across the full range of skin colors from light to very dark. Read More
In an effort to accelerate drug and diagnostic advances in multiple sclerosis (MS), non-alcoholic fatty liver disease and other conditions, Quest Diagnostics and Decode Health are working on a national platform for gathering and storing trial participant specimens for future RNA analysis. Read More
Sensoria Health and Padula Research Technologies (PRT) will be presenting details of NeurOpTrek and its sock sensor tool to assess the risk of falling at the American Academy of Optometry annual meeting in San Diego, Oct. 26-29. Read More