FDA approved a wearable tracking device, the remote patient monitoring platform

Recently, FDA approved a wearable tracking device from current health, That is, remote patient monitoring platform (RPM), as a class II medical device, is used for treatment and rehabilitation services after discharge. The approved device includes Bluetooth integration with other devices to track patient indicators, and the patient terminal is equipped with a chat device […]

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FDA introduces a tool for non clinical testing of ultrasound equipment

FDA has established the mddt program to support the development of validated, qualified methods, materials, and measurements. The goal is to reduce the risk and uncertainty of equipment development by providing the company with a set of tools and technologies accepted by FDA, rather than evaluating the tools used in the industry on a case […]

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Dhera takes the lead in digital healthcare for Alzheimer’s disease

The FDA has awarded the digital therapy of dthera sciences as a breakthrough device for patients with Alzheimer’s disease. Dthra’s device, dthr-alz, provides memory therapy to treat agitation and depression in some patients with Alzheimer’s disease. Upon receipt of the status information, dthera will benefit from FDA input and will give priority to review after […]

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FDA has made breakthrough progress in promoting global medical devices

The U.S. Food and drug administration director Scott Gottlieb said on Thursday that the agency has received and inspected nearly 600 single audit plans for medical devices from foreign regulatory partners as the number of participating production bases has soared since last year. William Maisel, director of the FDA’s office of equipment evaluation, told lawyers, […]

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FDA’s latest draft guidelines on medical magnetic resonance safety

The MRI environment is strictly controlled: it can be dangerous for patients with metal (including metal used in some medical devices) or their body attachments. Pacemakers, nerve stimulators, insulin pumps, artificial heart valves and cochlear implants are among the devices that can bring risks, and device manufacturers are designing MRI compatible versions. For example, in […]

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