[ad_1] Fitbit’s $329 Sense smartwatch just earned clearance from the FDA (and the EU’s regulatory body) for its electrocardiogram (ECG) app. When the “advanced health” wearable arrives this October, it will be able to assess heart rhythms for atrial fibrillation, or AFib. AFib is a heart condition that affects more than 33.5 million people globally […]
Category: fda
FDA approves first automated insulin system for kids
[ad_1] The device’s sensor that’s attached to the patient’s body can measure glucose levels under the skin every five minutes. It also comes with a pump and an infusion patch connected to the pump with a catheter to deliver insulin. That means the device will automatically adjust or withhold insulin to regulate the patient’s sugar […]
Abbott’s 15-minute, $5 COVID-19 test gets FDA authorization
[ad_1] Abbot Laboratories It’s an antigen test, as opposed to the slower lab-based PCR testing that has kept people waiting hours, days and weeks for results, and uses a lateral-flow approach similar to home pregnancy test kits. According to the Mayo Clinic, antigen tests work by detecting certain proteins specific to this virus, and work […]
Fitbit’s COVID-19 ventilator gets emergency FDA approval
[ad_1] Fitbit is one step closer to putting its Flow ventilator into use during the pandemic. The FDA has given Fitbit an Emergency Use Authorization for the Flow to help with severe COVID-19 cases. It still doesn’t have customers lined up, but it’s “in talks” with US government agencies to gauge needs and hopes to […]
Eight US companies will manufacture NASA’s COVID-19 ventilator
[ad_1] The eight manufacturers selected to produce VITAL stretch from Connecticut to California and from Minnesota to Texas. JPL did not say when the device might be ready for use. NASA/JPL-Caltech Next, JPL is evaluating international manufacturers from countries including Brazil, India, Malaysia and Mexico. Those manufactures will also receive free licensing through Caltech. “The […]
FDA approves a rapid COVID-19 test that uses CRISPR
[ad_1] “Sherlock enables rapid identification of a single alteration in a DNA or RNA sequence in a single molecule,” said Sherlock Biosciences co-founder David Walt. “That precision, coupled with its capability to be deployed to multiplex over 100 targets or as a simple point-of-care system, will make it a critical addition to the arsenal of […]
FDA clears Formlabs’ 3D-printed BiPAP-to-ventilator converter
[ad_1] Formlabs/Lee Weissman For hospitals that might not be able to print their own, Formlabs is using 150 3D printers at its Massachusetts headquarters to print the adapters. Once production is fully ramped up, the company expects to print up to 3,000 parts per day. “Formlabs’ EUA for BiPAP adapters signifies the need for these […]
NASA will license its FDA-approved ventilator to manufacturers for free
[ad_1] “Now that we have a design, we’re working to pass the baton to the medical community, and ultimately patients, as quickly as possible,” said Fred Farina, chief innovation and corporate partnerships officer at Caltech. The design offers a few key benefits. NASA says it can be built faster and maintained more easily than traditional […]
Lab-in-a-box test can detect COVID-19 in 5 minutes
[ad_1] The key is its use of molecular testing that looks for a small section of the SARS-CoV-2 virus’ RNA and amplifying that segment until there’s enough to detect. Other testing methods can take hours or days to produce viable results. Abbott is in the midst of ramping up production and expects to deliver 50,000 […]
FDA allows new coronavirus testing tech before it gets emergency approval
[ad_1] There’s currently just one emergency authorization for COVID-19 in use by the CDC and public health labs, the FDA added. Early US tests were hurt by kits that included a bad reagent that rendered the tests ineffective. To some degree, this is damage control. On top of the problems with early tests, there have […]