Literally the size of a quarter, the Dab is an unobtrusive Holter ECG/EKG that rests comfortably on your chest, constantly reading your heart’s movements. Designed to be minimal, non-invasive, and simple, the Dab tries to bridge the gap between medical appliances and wearables. Its tiny yet classy design sits on your chest via a gel patch, while the electrodes capture your heart activity. The Dab’s dry-electrodes allow it to be used and reused, unlike disposable electrodes that lead to large amounts of medical waste. They constantly measure one’s heart activity (requiring periodic charging via their wireless charging hub), and keep logs of accurate readings, quietly sitting on your chest while you absolutely forget that they’re even there in the first place! 

Aktiia has beaten Fitbit, Apple and others to get regulatory approval to sell a bracelet to measure users’ blood pressure continuously.

Duodenoscopes are important medical devices that are used for endoscopic retrograde cholangiopancreatography (ERCP) procedures. However, the devices have had serious problems in the past.

Keep your iPhone a safe distance away from any implanted medial devices implanted in your body, such as pacemakers or defibrillators.

Key Points – FDA will publish draft guidance on its Predetermined Change Control Plan in 2021 and host a public workshop on transparency requirements around AI/ML-based devices. …

a prescribed digital therapeutics (PDT) company developing advanced electroceuticals for migraine and other pain conditions, today announced that its Nerivio® therapeutic device has received the Food and Drug Administration clearance to market for an expanded indication for acute treatment of episodic or chronic migraine in people 12 years and older. The use of the device in the treatment of adolescents is supported by a study recently published in Headache.

Boston Scientific has landed FDA clearance for its Vercise Genus Deep Brain Stimulation (DBS) System. This is the fourth generation of the company’s DBS devices, which are designed to have a longer battery life, improved targeting to reduce symptoms, and make programming and management easier.

Canon Medical is releasing its Aquilion Exceed LB advanced CT scanner that features an impressively large 90 centimeter bore.The wide opening and…

Beckman Coulter plans to launch a $4 coronavirus antigen test designed for mass screening, with the goal of shipping up to 25 million per month by March.

Researchers at UC Berkeley have developed a rapid test for SARS-CoV-2 that uses an enzyme to cleave viral RNA, initiating a fluorescent signal that can be detected using a smartphone camera, and which can provide a quantitative measurement of the level of viral particles in the sample. The test produce a result in as little as 30 minutes and does not require bulky or expensive laboratory equipment. Rapid testing is key to measuring and stopping the spread of COVID-19, but current tests, such as PCR, are time consuming and require expensive laboratory equipment, creating a bottleneck in obtaining results. Researchers have been developing alternatives, and this latest technology was rapidly repurposed when the pandemic began. Originally intended to detect HIV in blood samples, the Berkeley researchers have pivoted to allow the device to detect SARS-CoV-2 in nasal swab samples. The test relies on CRISPR-Cas, originally developed as a gene editing technology. When a pre-programmed Cas13 enzyme is added to the sample, it can cleave RNA sequences from the SARS-CoV-2 virus. This results in other nearby sequences being cleaved also, including a probe that releases fluorescent light when cleaved. The device uses a laser to excite this fluorescence and a smartphone camera can then detect the light, providing a quantitative measurement of the viral particles present in the sample. “It’s super exciting to have this quantitative aspect in the assay,” said Melanie Ott, a researcher involved in the study. “PCR is the gold standard, but you have to go through so many steps. There are huge opportunities here for pathogens and for biology in general to make RNA quantification more precise.” Strikingly, the test takes just 30 minutes. “Our study shows that we can do the detection part of this assay very quickly, making the measurement with mass-produced consumer electronics,” said Daniel Fletcher, another researcher involved in the study. “We don’t need fancy laboratory equipment.” The technology could provide a viable alternative to PCR for routine COVID-19 testing. “One reason we’re excited about CRISPR-based diagnostics is the potential for quick, accurate results at the point of need,” said Jennifer Doudna, a third researcher involved in the project. “This is especially helpful in places with limited access to testing or when frequent, rapid testing is needed. It could eliminate a lot of the bottlenecks we’ve seen with COVID-19.” See a video about the technology below. Study in Cell: Amplification-free detection of SARS-CoV-2 with CRISPR-Cas13a and mobile phone microscopy Via: UC Berkeley