Senseonics Holdings Inc has announced that people with diabetes using the Eversense® brand Continuous Glucose Monitoring Systems, in EMEA markets now have the option to invite others to remotely view their real-time glucose readings and alerts from anywhere.
Samsung’s latest phones, the Galaxy S9 and S9+, will incorporate a new digital health app that will track users' blood pressure and stress level while helping researchers collect data. Seoul-based Samsung Electronics teamed up with the University of California San Fransisco to develop the research app, called My BP Lab.
The US Food and Drug Administration (FDA) on Tuesday finalized a rule that requires medical device clinical investigations conducted outside the US to flexibly conform with good clinical practice (GCP) standards.
On February 6, 2018, the China Food and Drug Administration (CFDA) and its Center for Medical Device Evaluation (CMDE) issued a draft guidance entitled “Guidance on the Review of Medical Devices for Preventing and Treating Rare Diseases.” The draft guidance is based on the reform measures recently outlined in the government’s broad blueprint for drug and device reform—the Opinion on Strengthening the Reform of the Drug and Medical Device Review and Approval Process to Encourage Drug and Medical Device Innovation (“Opinion 42”).
Managing your medical device product development project can be a daunting task. There are regulations and paperwork to manage, along with expectations such as deadlines or goals for getting the device to market.
Materials are one of the most common causes of failure in medical devices, especially for plastic. Records show that material failure is responsible for 30 to 40 percent of all FDA recalls on medical devices.
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