FDA clears PhotoinCare’s handheld OCT (optical coherence tomography) scanner for checking ear infections

February 28, 2020 The TOMi Scope diagnostic device uses optical coherence tomography, or OCT, to scan the middle ear with near-infrared light and provide a cross-section image similar to an ultrasound.  It can then determine whether fluid is present and characterize its type and density, even in cases with heavy wax buildup.  “Current tools can … Read more

Saluda’s closed-loop spinal cord stimulator demonstrates personalized pain control

February 25, 2020 In pivotal study results published in The Lancet Neurology, Evoke spinal cord device reduced or eliminated the use of opioid painkillers after one year among 55% of treated patients, compared to 40% of those who received open-loop stimulation.  Evoke gauges the body’s reaction to every electrical pulse and works to optimize its … Read more

Withings’ new smartwatch to combine ECG and sleep apnea detection

February 20, 2020 The ScanWatch also works as an activity and fitness tracker, with the ability to measure V02 max, which gauges the amount of oxygen utilized during aerobic exercise, in addition to its electrocardiogram (ECG).  “ScanWatch is our most ambitious medical tracker and purposely designed to detect the early presence of AFib and sleep … Read more

EU MDR/IVDR: US Raises ‘Serious Concerns,’ Urges 3-Year Implementation Delay

February 18, 2020 In a 24 July statement to the World Trade Organization’s (WTO) Committee on Technical Barriers to Trade, the US discusses the MDR/IVDR issues facing industry.  “Our industry is worried about their continued access to the EU’s USD 125 billion medical device market, USD 20 billion of which is supplied by US products.” … Read more

FDA Finalizes Rule to Go From Paper to Electronic Device Submissions

February 15, 2020 The Agency said the rule, proposed in September 2018 and will take effect in 30 days, is in response to an executive order from the Trump Administration in 2017 made famous as the “one-in, two-out” order.  FDA’s rule is meant to improve the device premarket submission program and create a more efficient … Read more

Coopervision wins FDA nod for first contact lens to slow advance of myopia in children

February 11, 2020 Specifically, the FDA indication said that “Misight (omafilcon A) daily wear single use soft contact lenses are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of … Read more

Google shells out $2.1B for Fitbit and its health-focused wearables

February 06, 2020 The tech giant described the deal as an opportunity to “invest even more in Wear OS” — Google’s software ecosystem for Android-powered smartwatches, which has struggled over the years to gain a large market share — as well as a new avenue for the company to build tools to enhance health.  “By … Read more

U.K. researchers developing ‘smell-powered diagnostic to sniff out diseases

February 05, 2020 A new spinout from the university, Rosa Biotech, has raised £760,000, or about $982,000, to commercialize its biosensing platform, which the company says could have applications in any industry needing to profile and analyze complex biological mixtures.  The project was inspired by the ability of trained dogs to smell malaria and Parkinson’s … Read more