A South Korean manufacturer which claims to develop the world's first AI-powered doll companion for seniors has recently registered its product in the United States.
Hyodol has recently announced that its AI companion doll of the same name has been registered as a medical device with the US Food and Drug Administration.
WHAT IT'S ABOUT
Hyodol describes its doll, first released in 2019, as a...
The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing AI-enabled medical devices.
"This final guidance is part of the FDA's broader commitment to develop and apply innovative approaches to the regulation of device software functions and contains...
The Food and Drug Administration (FDA) has released its perspective on regulating AI in healthcare and biomedicine, stating that oversight needs to be coordinated across all regulated industries, international organizations and the U.S. government.
The Agency says it regulates industries that distribute their products to the global market, and therefore U.S. regulatory standards must be...
The FDA announced the Apple Watch atrial fibrillation (AFib) tool is qualified for use in clinical trials through its Medical Device Development Tools (MDDT) program, thus enabling researchers to use it to detect arrhythmias or abnormal heart beat.
Apple's tool is the first digital health tool to be qualified under the MDDT program, a voluntary program aimed at evaluating devices for use in...
Philips received a warning letter from the FDA in February, which the Agency posted on Tuesday, stating that an inspection of the tech giant's manufacturing facility in Suzhou, China, that makes CT and ultrasonography systems revealed it was not in compliance with the Quality System Regulation's good manufacturing requirements.
The FDA said an inspection of the facility in October showed the...
The Food and Drug Administration (FDA) announced the launch of a new initiative, Home as a Health Care Hub, that focuses on using augmented reality and virtual reality to improve health equity by reimagining the home environment as part of a healthcare system.
The FDA contracted with an architectural firm that designs buildings with health and equity in mind to consider what will be needed to...
Shareholders of KOSDAQ-listed Lunit have recently participated in the company's recent capital raise, paying-in $150 million to fund its development of "next-generation" products and further expansion in the West.
Meanwhile, the AI cancer diagnostics solutions provider obtained its third 510(k) clearance from the United States Food and Drug Administration.
WHAT IT'S FOR
In a company disclosure,...
On Thursday, the FDA Center for Devices and Radiological Health released updated final guidance for its Breakthrough Devices Program, aimed at verifying medical devices on the market are safe and effective, and improve healthcare inequities.
The final guidance defines the FDA's interpretation of "more effective" as encompassing all the information about the device, including the risks and...
Aetion, a startup focusing on real-world evidence in healthcare, announced a five-year research collaboration with the FDA's Oncology Center of Excellence (OCE).
The OCE will use Aetion's Evidence Platform to find and analyze sources of real-world data that could be used for research on cancer prevention, clinical care, diagnostics and treatment.
The collaboration will assess real-world...
The FDA posted a notice saying the recall of Insulet's Omnipod DASH Insulin Management System Personal Diabetes Manager is a Class I, the most serious recall indicating the devices could cause serious injuries or death.
The Massachusetts-based company's system consists of two parts: A wearable and tubeless pump that delivers insulin, dubbed the Pod, and a remote controller with a battery pack...
