UK-based Ultromics announced Tuesday that its machine learning-based decision-support system used to help detect heart failure with preserved ejection fraction had received FDA 510(k) clearance.
EchoGo Heart Failure, which was developed in partnership with the Mayo Clinic, aids physicians in diagnosing the condition by providing them with echocardiogram imaging results in people over 25 years old...
Israeli startup AEYE Health announced last week it had received FDA 510(k) clearance for its AI-based screening tool for diabetic retinopathy.
The AEYE-DS system, which received the agency's green light earlier this month, uses images from each eye to detect signs of more-than-mild diabetic retinopathy, a complication from diabetes that can lead to blindness or other serious vision problems.
It'...
Elizabeth Holmes, former CEO of the failed blood-testing startup Theranos, on Friday was sentenced to more than 11 years in prison for defrauding investors.
The sentence ends a yearslong saga that raised questions about Silicon Valley's "move fast and break things" culture, particularly as it relates to healthcare.
Holmes, 38, was convicted of conspiracy to defraud investors and three counts of...
The FDA on Thursday released draft guidance for its Breakthrough Devices Program aimed at reducing health disparities.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...
In late September, the FDA released its final report on the Software Precertification Pilot Program, which it launched in 2017 to explore different regulatory approaches for digital health tools.
By 2022, the agency determined a new regulatory framework would be useful for software as a medical device, but it couldn't do that alone.
"We are not fully capitalizing on these capabilities and...
Tasso received FDA 510(k) clearance for its patch-like blood collection device, the Tasso+.
The device includes a lancet, which adheres to the arm, that connects to a test tube for collection. After users rub their arm or use a heat pack and sanitize the test site, they press a button on the front of the device to begin drawing capillary blood. Then the tube can be removed and sent to a lab for...
AI-backed imaging and care coordination company Viz.ai received FDA 510(k) clearance for an algorithm that could help determine the severity of a pulmonary embolism.
The startup received the agency's green light late last month for its RV/LV ratio algorithm, which measures the diameter of the ventricles of the heart to provide the ratio of the maximum right ventricle diameter compared with the...
The Federal Trade Commission is investigating Amazon's $3.9 billion acquisition of primary care provider One Medical.
According to a filing with the Securities and Exchange Commission, One Medical parent 1Life Healthcare and Amazon both received requests from the FTC for more information regarding the deal on Sept. 2. The planned acquisition was first announced in late July.
In the filing, 1Life...
Online eyewear and vision care company Visibly announced it had received FDA 510(k) clearance for its at-home vision test.
The Visibly Digital Acuity Product uses a touchscreen mobile device, like a smartphone, paired with a computer to test visual acuity, or how sharp a user's vision is at a distance.
The computer screen displays optotypes, or specifically shaped symbols or letters for vision...
Bodyport announced it has received the FDA green light for its connected scale that remotely monitors patients with fluid management conditions such as heart failure and kidney disease.
The Cardiac Scale, which is intended for people 21 and over who weigh less than 397 pounds, can be used to track body weight, pulse rate, center of pressure and peripheral impedance, which can signal changes in...
_0_4.jpeg?itok=2h36gRFV "A sign outside Amazon headquarters.")
