We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The Swiss Parliament has cleared the way for legislation to allow non-CE-marked medical devices — including those approved or cleared by the FDA — to be marketed in Switzerland, where only CE-marked medical devices are currently available. Read More
Speakers at a Food and Drug Law Institute virtual meeting on digital health technology last week agreed that a coordinated vulnerability disclosure (CVD) process is needed to address cybersecurity threats to medical devices. Read More
B. Braun Medical’s Space Infusion Pump System wireless devices have earned Underwriter Laboratory (UL) 2900-2-1 Cybersecurity Assurance Program (CAP) certification, a standard supported by the FDA. Read More
Devicemakers are having difficulty making sense of a recent FDA final guidance targeting clinical decision support software (CDS) for machine learning (ML) products, according to remarks made during a virtual panel held Thursday by the Food and Drug Law Institute (FDLI). Read More
Over the past several years, the FDA has demonstrated an increasing willingness to consider real-world data (RWD) — data derived from sources other than traditional, tightly controlled clinical trials — in its regulatory decisionmaking. Sources of RWD are diverse but often include patient registries, medical records and information derived from wearable devices or apps. Read More
As demand for wearable medical devices that track health measures continues to rise, manufacturers will have to navigate the very real concerns of data privacy as well as more closely define whether a device is clinical or consumer-facing, according to panel members speaking Thursday at a Food and Drug Law Institute webinar, Current Developments in Digital Health Technology and Regulation. Read More
The FDA has issued a warning letter to a clinical trial site in Illinois for failing to submit an investigational new drug application (IND) before launching a clinical investigation of a combination drug-device product. Read More
C2N Diagnostics announced the planned launch of its new diagnostic blood test, PrecivityAD2, which uses mass spectrometry and a statistical algorithm to detect the two key drivers behind Alzheimer’s disease — tau and amyloid beta proteins. Read More
Women with breast or ovarian cancer had fewer hot flashes, less psychiatric distress and better quality of life after using XRHealth’s virtual reality (VR)-artificial intelligence (AI)- based technology, researchers reported in the journal Healthcare. Read More