[ad_1] According to the company, the AI can identify heart murmurs with 87 percent sensitivity and 87 percent specificity. In comparison, primary care physicians unaided by AI had a 43 percent sensitivity and 69 percent specificity, according to a study in European Heart Journal. When used with the Eko DUO stethoscope, the AI reportedly detected […]
Category: fda
FDA warns hospitals about security flaws in some GE medical equipment
[ad_1] Those vulnerabilities, the FDA said, could allow bad actors to remotely take control of the devices in order to generate false alarms or silence real ones. An attacker could, for instance, stop the system from notifying providers about a patient’s cardiac status, putting their life in danger. Thankfully, the FDA has yet to receive […]
FDA bans production, sale of fruit- and mint-flavored vape pods
[ad_1] The new restrictions make some important exceptions. First, they permit tobacco- and menthol-flavored goods. They also apply only to cartridge-based products, which the FDA says are easier for teens to acquire and conceal. Tank-based vaping devices, like those sold in vape shops that typically cater to adult smokers, are not restricted by the new […]
WSJ: FDA vape ban will target fruit flavored pods
[ad_1] A few days ago, the FDA officially raised the minimum age of sale for tobacco products from 18 to 21, and according to a Wall Street Journal report, it’s close to announcing a new set of restrictions specifically for e-cigarettes. In a move that is supposed to address teen vaping by targeting products they’re […]
FDA issues its first approval for an Ebola vaccine
[ad_1] A month ago the European Union issued marketing authorization for a vaccine to prevent the Ebola virus in adults, and now the FDA has approved it. While noting that Ebola cases in the US have been very rare, director of the FDA’s Center for Biologics Evaluation and Research Peter Marks said in a statement […]
The FDA is fast-tracking an algorithm that screens for heart failure
[ad_1] The algorithm was introduced in a study published in Nature Medicine in January 2019. It was trained on 44,959 patients and tested on 52,870 patients. In those initial tests, it showed 87.5 percent accuracy. The algorithm is designed to work with Eko’s DUO digital stethoscope. The handheld device can be placed on the left […]
FDA clears an interoperable, automated insulin pump
[ad_1] The software needed to make this work will be ready in January 2020, although you can’t expect to walk into a store and buy this. US law will still require that you buy the pump from (or on the order of) a physician. This isn’t the first time the FDA has cleared multiple devices […]
In-brain electrodes are the latest weapon against opioid addiction
[ad_1] Deep brain stimulation, or DBS, is a form of surgery that places electrodes inside the patient’s brain — in this case, in the self-control and pleasure centers. An external device sends electrical pulses to interrupt the patient’s typical brain behavior, such as an addict’s craving a drug or an obsessive compulsive disorder patient’s feeling […]
Vape brand Juul is reportedly at the center of a criminal probe
[ad_1] This will be another unwelcome challenge for the quickly-growing company, which has come under fire for the ways its sleek vaporizers have found appeal with young people. The Federal Trade Commission, Food and Drug Administration (FDA) and several other state attorney generals are already investigating the company’s marketing practices, although Juul maintains it never […]
CDC warns against vaping until it figures out what’s making people sick
[ad_1] There are a lot of rumors and unsubstantiated chatter around the risks of vaping, and the CDC admits it has plenty of questions. It says it’s too early to pinpoint a single product or substance common to all cases. It’s also unclear what role THC-containing products play in the illness, as many patients report […]