Lori A Carr

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

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

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

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

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

January 30, 2020 TÜV Rheinland joins IMQ, BSI Assurance UK, TÜV SÜD Product Service and DEKRA as the only NBs that can certify device makers for MDR compliance. European device groups have expressed concern about a shortage of notified bodies to conduct audits and certify device makers in time to comply with the new regulations … Read more

January 28, 2020 Developments with bioengineered miniature organs called organoids are not quite there yet.  However, a multidisciplinary team at the hospital’s Center for Stem Cell & Organoid Medicine (CuSTOM) say they have made a breakthrough discovery that brings them a step closer.  Cincinnati Children’s Hospital’s CuSTOM team — made up of scientists, clinicians, geneticists, … Read more

January 23, 2020 The first, built around the coordinating center of the National Evaluation System for health Technology, or NEST, aims to link data from sources such as clinical registries, electronic health records and billing claims as it works to build up the quality and usability of real-world evidence sources.  While the NEST coordinating center … Read more

January 21, 2020 The Agency (the United States Food and Drug Administration – FDA) modeled the voluntary regulatory process after its selective Breakthrough Devices Program; however, with the goal of recognizing and rewarding innovation in areas that might not make the cut.  While the breakthrough program focuses on life-threatening diseases and unmet medical needs, the … Read more

January 16, 2020 Given the common complaint that they do not have enough time to spend with patients, busy doctors are making less time to meet with pharma representatives, according to the annual ePharma physician report from Decision Resources Group, a healthcare research and consulting company. As physicians increasingly struggle to balance their time with … Read more