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...
The FDA on Thursday released draft guidance for its Breakthrough Devices Program aimed at reducing health disparities.
The draft proposes updates that would clarify how the program would apply to medical devices that could benefit groups affected by health inequities, including disparities based on race, sex, ethnicity and access to care. The agency will also assess if the developers have...
Led by Ally Bridge Group and with the help of its existing shareholders, venture-backed Ceribell, Inc. has raised $50 million.
The funding was structured as an extension of its $53 million Series C raise, which was announced in April 2021.
WHAT IT DOES
Ceribell developed a rapid response electroencephalography (EEG) system to make diagnosing neurological patients more efficient. It says that its...
Medical AI company JLK from South Korea has received medical device approval from Food and Drug Administration Thailand for its AI brain image analysis solution.
Founded in 2014, the startup offers a range of image analysis tools under its Medihub platform, which supports the diagnosis of neurological and cancer diseases. It also operates other AI-powered platforms for telehealth, medical...
ASX-listed ResApp Health has received the US Food and Drug Administration's 510(k) clearance for SleepCheckRx, its mobile sleep apnoea screening app.
Introduced two years ago, SleepCheck is an at-home test for adults who are at risk of moderate to severe obstructive sleep apnoea. It screens for the condition by analysing breathing and snore sounds recorded via phone.
It has been approved as a...
CardieX files 510(k) for dual blood pressure, arterial health monitor
Australia-listed health tech firm CardieX has filed a 510(k) premarket submission with the US Food and Drug Administration for its dual blood pressure and arterial health monitor.
Called the CONNEQT Pulse, the health monitor features CardieX's FDA-cleared SphygmoCor technology which measures central blood pressure to obtain...
Baby tech company Owlet has pulled its connected-sock wearables from the market following an October FDA warning letter that the company was out of regulatory compliance. The news, which was first spotted by Deseret News, comes less than a year after the company went public.
The sock in question was designed to track an infant’s heart rate, skin temperature, blood oxygenation and sleep data....
The Food and Drug Administration has granted AppliedVR De Novo clearance to market its EaseVRx virtual reality system to treat chronic lower back pain.
The prescription device includes a VR headset and controller plus a “Breathing Amplifier” that’s used to train the user in deep breathing. Patients can participate in 56 VR sessions that use cognitive behavioral therapy to treat pain. The...
