• Intel's 2023 oneAPI and AI tools will deliver capabilities to enable the Intel Max Series products' advanced features. (intel.com)
  • LOS ALTOS, Calif. and CAMBRIDGE, Mass. (Sept. 19, 2023) - Today, Toyota Research Institute (TRI) announced a breakthrough generative AI approach based on Diffusion Policy to quickly and confidently teach robots new, dexterous skills. (toyota.com)
  • Breakthrough Therapy (BT) Designation and Regenerative Medical Advanced Therapy (RMAT) Designation are two of the expedited programs that may apply to cellular and gene therapy products that are intended to treat, modify, reverse, or cure a serious condition. (fda.gov)
  • Refer to Guidance for industry Expedited Programs for Serious Conditions - Drugs and Biologics , Expedited Programs for Regenerative Medicine Therapies for Serious Conditions Guidance for Industry , and SOPP 8212: Management of Breakthrough Therapy-Designated Products: Sponsor Interactions and Status Assessment Including Rescinding for more information on BT and RMAT designation criteria and other expedited programs. (fda.gov)
  • With regard to the number of meetings associated with RMAT or BT designation, products that receive both designations are treated as having a single designation. (fda.gov)
  • For example, a product that receives both RMAT and BT designation will be granted only one Initial Comprehensive Meeting. (fda.gov)
  • After a product receives BT or RMAT designation, sponsors are encouraged to request an "Initial Comprehensive Meeting", which is a multidisciplinary comprehensive discussion of the drug development program, including planned clinical trials and plans for expediting the manufacturing development strategy. (fda.gov)
  • If another milestone meeting is pending at the time that a product receives BT or RMAT designation, OTP may suggest combining the Initial Comprehensive Meeting with the milestone meeting. (fda.gov)
  • If a product receives BT or RMAT designation late in product development, particularly after a pre-BLA meeting has been held, an Initial Comprehensive Meeting is not necessary. (fda.gov)
  • FloBio , a medical diagnostics company, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. (clpmag.com)
  • PAVmed Inc. , a differentiated, multiproduct medical device company, announced that the company's majority owned subsidiary, Lucid Diagnostics Inc. has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its EsoGuard Esophageal DNA Test on esophageal samples collected using its EsoCheck Cell Collection Device in a prevalent well-defined group of patients at elevated risk for esophageal dysplasia due to chronic gastroesophageal reflux disease (GERD). (mpo-mag.com)
  • EsoGuard's FDA Breakthrough Device designation represents a major milestone for PAVmed and Lucid," said Lishan Aklog, M.D., PAVmed's chairman and CEO and Lucid's executive chairman. (mpo-mag.com)
  • I am very excited that the FDA deemed EsoGuard worthy of Breakthrough Device designation. (mpo-mag.com)
  • I am very gratified that FDA agreed with us that EsoGuard satisfies all of its criteria for Breakthrough Device designation for the proposed indications for use," said Alberto Gutierrez, Ph.D., Lucid's regulatory consultant and former director of the FDA's Office of In-Vitro Diagnostics (OIVD). (mpo-mag.com)
  • I have participated in the designation of several IVD Breakthrough Devices and understand the value this brings to Lucid's clinical development program. (mpo-mag.com)
  • Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. (wikipedia.org)
  • CDER receives approximately 100 requests per year for breakthrough designation. (wikipedia.org)
  • Breakthrough designation applications are submitted as an amendment to the IND applications, usually prior to end of Phase II meeting. (wikipedia.org)
  • Critics have said that the name is misleading and provides companies that obtain a breakthrough designation for a drug candidate with a marketing advantage that may be undeserved. (wikipedia.org)
  • The FDA guidance states: "Not all products designated as breakthrough therapies ultimately will be shown to have the substantial improvement over available therapies suggested by the preliminary clinical evidence at the time of designation. (wikipedia.org)
  • The fourth expedited approval mechanism-the Breakthrough Therapy designation-applies to a new drug product if it "is intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints. (wikipedia.org)
  • SANTA BARBARA, Calif.--HyperSolar, Inc. (OTCBB: HYSR), the developer of a breakthrough technology to produce renewable hydrogen and natural gas using water and solar power, today announced specific details of its plan for the development of the world's first nanotechnology-based, zero-carbon process for the production of renewable hydrogen and natural gas. (altenergymag.com)
  • HyperSolar is developing a breakthrough technology to produce renewable hydrogen and natural gas using sunlight, water and carbon dioxide. (altenergymag.com)
  • The U.S. government has announced a proposed $7 billion (for starters) on desperately needed breakthroughs in clean hydrogen production. (yahoo.com)
  • As of August 2020, the FDA had granted breakthrough device designations to 298 medical devices in total since its inception, including 50 for the year 2020. (wikipedia.org)
  • Both products were given priority review, orphan drug, and breakthrough therapy designations by the agency. (medscape.com)
  • WWLP) - The State Department of Public Health released its weekly report on breakthrough infections. (wwlp.com)
  • I am thrilled to announce that Aspen Mtell ® was named as a "Breakthrough Product" of 2021 by Processing Magazine in the Process Automation category. (aspentech.com)
  • Drugs that have been granted breakthrough status are given priority review. (wikipedia.org)
  • At IFA 2019, Western Digital is showcasing its latest offerings from its WD_Black® line of gaming products, WD® and SanDisk® brands. (westerndigital.com)
  • Our extensive industry-leading portfolio is a great example of that commitment,' said David Ellis, vice president of product marketing for content solutions, Western Digital. (westerndigital.com)
  • Western Digital offers the industry's broadest portfolio of products and solutions to help people capture, preserve, access and manage their personal content. (westerndigital.com)
  • Western Digital branded products are all designed with the consumer experience as our top priority. (westerndigital.com)
  • Breakthrough Devices receive priority FDA review, and a bipartisan bill before Congress (H.R. 5333) seeks to require Medicare to temporarily cover all Breakthrough Devices for three years while determining permanent coverage. (mpo-mag.com)
  • Futuristic innovations enabling the transformation of waste to useful products will aid in the increased adoption of sustainable raw materials and reduced usage of synthetic materials. (researchandmarkets.com)
  • This research study identifies the need for waste to product transformation and how breakthrough innovations in the conversion of waste to the product can aid in mitigating challenges with existing waste management methods. (researchandmarkets.com)
  • To prosper, firms must develop major product and service innovations. (mit.edu)
  • Companies need new strategies to harness the rapid pace of technological change, create breakthrough innovations and thrive in a time of unprecedented disruption. (accenture.com)
  • Breakthrough innovations drive more than just growth and profitability. (accenture.com)
  • Refer to SOPP 8212: Management of Breakthrough Therapy-Designated Products: Sponsor Interactions and Status Assessment Including Rescinding Appendix A on Initial Comprehensive Meeting. (fda.gov)
  • The FDA acknowledges that the name "breakthrough therapy" may be misleading. (wikipedia.org)
  • Tofino Security announced today that a Tofino -based firewall, the Triconex® / Tofino™ OPC Firewall, has been selected as a Breakthrough Product of the Year for 2010 by Processing Magazine. (tofinosecurity.com)
  • The transformation products (TPs) of the pharmaceuticals revealed more incompletely oxidized TPs occurred in the phosphate- and (bi)carbonate-containing mFe-PS systems, and indicated that H2PO4·/HPO4·- mainly degraded pharmaceuticals via a benzene ring-opening reaction while CO3·- preferentially oxidized pharmaceuticals via a hydroxylation reaction. (bvsalud.org)
  • I'm writing you today because I want to tell you about a breakthrough scientific discovery about Colitis. (7wins.eu)
  • The secretive award committees never give away any hints in advance of who could win, but here's a look at five big scientific breakthroughs that haven't yet received a Nobel prize. (talkingpointsmemo.com)
  • The product includes claims such as "miracle cure," "secret ingredient," "scientific breakthrough," or "ancient remedy. (medlineplus.gov)
  • They believe this is a much sought-after breakthrough, as it solves an ethical dilemma, leads to higher scientific accuracy and thus saves the pharmaceutical industry a lot of money. (lu.se)
  • Biomedical and pharmaceutical technologies are important scientific breakthroughs that contribute to increased welfare. (lu.se)
  • Recent research into the innovation process has made it possible to develop 'breakthroughs' systematically. (mit.edu)
  • What makes an innovation a breakthrough? (accenture.com)
  • While breakthrough innovation starts with a great idea, success lies in a company's ability to bring that idea to life in a radically compressed timeframe. (accenture.com)
  • The FDA Breakthrough Device Program was created to offer patients more timely access to breakthrough technologies which "provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions" by expediting their development, assessment and review through enhanced communications and more efficient and flexible clinical study design, including more favorable pre/post market data collection balance. (mpo-mag.com)
  • The award recognizes those products, services and/or technologies that have made significant contributions to the process industries within the past year. (tofinosecurity.com)
  • 5AM Ventures drives advances in breakthrough science through its investments across a wide spectrum of biotherapeutics and platform technologies and is currently investing out of its $450 million 5AM Ventures VII, L.P. and $300 million 5AM Opportunities II, L.P. funds. (advfn.com)
  • These are just some of the many breakthrough technologies supported by. (medlineplus.gov)
  • Kush Parmar, Managing Partner added "At 5AM Ventures, over the last 21 years, we have created and funded companies that have brought 20 life-changing products to market for patients with cardiovascular, respiratory and infectious diseases, as well as cancer, addiction and other neurological areas, and those requiring surgical intervention. (advfn.com)
  • Rather than bet on a single idea in a single field, leading firms build a dynamic portfolio of ideas for new business products or ventures at different stages of development. (accenture.com)
  • Both the current FDA-approved products, Rebyota and Vowst, were shown in randomized controlled trials to reduce recurrence of C. diff infection, compared with placebo. (medscape.com)
  • 274 (79%) vaccinated patients with breakthrough infection a cluster of cases among Massachusetts residents. (cdc.gov)
  • - U.K. officials tout a couple of breakthroughs in Brexit talks ahead of briefings by chief negotiators David Frost and Michel Barnier. (politico.eu)
  • This year, GE will be hosting commercial users and officials in nearly 50 cities, showcasing new advanced-technology products and solutions in areas ranging from architectural lighting to retail and outdoor lighting. (finchannel.com)
  • The product is marketed and sold by Invensys Operations Management, a global provider of technology systems, software solutions and consulting services to the process and manufacturing industries. (tofinosecurity.com)
  • Plant managers need the latest innovative technology to protect their products, their employees and the environment, as well as the communities they serve. (tofinosecurity.com)
  • here's a very brief overview of these tobacco products. (cdc.gov)
  • Enabled by glass: High-quality optical glass helped NIF's scientists to reach a spectacular breakthrough in clean energy production. (schott.com)
  • The scientists, doctors, engineers, inventors, innovators, and disrupters in Girl Genius have done incredible things-from developing life-saving medical breakthroughs and uncovering lost cities to inventing taco-delivery copters and experimenting with robots. (lindentreebooks.com)
  • These women have saved countless babies' lives, revolutionized the way scientists studied insects, invented products to help victims of natural disasters, and used satellites in space to solve dinosaur mysteries. (lindentreebooks.com)
  • OTP recommends that sponsors of regenerative medicine therapies engage in discussions with OTP review staff early during product development. (fda.gov)
  • Looking back, 2013 could well become known as selenium's breakthrough year, two major suppliers of the ingredient say. (nutraingredients.com)
  • This year, on-board exhibits include products in-use, educational information and innovative solutions, all focused on helping lighting customers reduce energy. (finchannel.com)
  • It was never meant to imply that these drugs are actually "breakthroughs," and it does not ensure that they will provide clinical benefit, but still critics complain that they are based on preliminary evidence, including changes in surrogate markers such as laboratory measurements, that often don't reflect "meaningful clinical benefit. (wikipedia.org)
  • As you may be aware, CDC has been partnering with colleagues at the U. S. Food and Drug Administration, state and local health departments and other public health and clinical stakeholders to investigate and gain a comprehensive understanding of e-cigarette or vaping product use associated lung injury. (cdc.gov)
  • The ads for the product use lots of technical or medical jargon. (medlineplus.gov)
  • The main application is for bread and tortillas products, and the first market targeted is North America, but the enzyme will be available worldwide. (foodnavigator.com)
  • The product, developed by Massachusetts-based Seres Therapeutics and marketed as Vowst, was approved by the U.S. Food and Drug Administration on April 26. (medscape.com)
  • Apple has a long history of designing products that aren't the first to be introduced in a particular category but still redefine the market. (valleycentral.com)
  • The new Invensys firewall is truly revolutionary because it was the first product on the market that protects integrated applications based on OPC Classic, the world's most widely used industrial integration protocol," remarked Eric Byres, security expert and technical officer at Tofino Security. (tofinosecurity.com)
  • "At a time of increasing price sensitivity and increasing market competition, on-going product development is crucial to survival," ​ say Frost & Sullivan. (foodnavigator.com)
  • Market research firm Datamonitor said worldwide food and beverage product introductions listing selenium as an ingredient declined from an average of around 50 in the 2008-2010 timeframe to just 38 in 2012. (nutraingredients.com)
  • This product is hands down the best lube on the market. (mountsplus.com)
  • The Intel Max Series product family brings high bandwidth memory to the broader market, along with oneAPI, making it easy to share code between CPUs and GPUs and solve the world's biggest challenges faster. (intel.com)
  • At MSP, we only offer Gun Cleaning Supplies from the most trusted brands like Breakthrough Clean . (mountsplus.com)
  • If you've been looking to the holiday season to invest in some Dyson hair products for yourself or a loved one, here's some good news. (kron4.com)
  • Because they need a solution sooner than most people, lead users have an incentive to create innovative products and services. (mit.edu)
  • That way, they can introduce new products or services that leverage a platform-based business model and deliver differentiated customer value. (accenture.com)
  • Falsified medicines are pharmaceutical products that pretend to be genuin and to combat diseases, but they may be ineffective or harmful. (lu.se)
  • I am at the National Organization for Rare Diseases (NORD) Orphan Products Breakthrough Summit with Jim Powers, the CEO of HemoShear (Charlottesville, Virginia). (medscape.com)
  • Details in fire orchid make their way from the upper to the sole plate of the boots in an exciting style that will make sure you have a breakthrough on the pitch this season. (soccerpro.com)
  • FMT centers like OpenBiome "will continue to provide access for patients who either don't have the ability to get the FDA-approved products because of insurance coverage, or for financial reasons, or maybe neither of the new products is appropriate for them," she said. (medscape.com)
  • this complex investigation spans almost all states and involves over 2,000 patients, as well as a wide variety of brands, substances and e-cigarette or vaping products. (cdc.gov)
  • All patients have reported a history of using ecigarettes or vaping products. (cdc.gov)
  • RÉSUMÉ La présente étude a examiné les connaissances et la compréhension actuelles des patients en matière de substitution par des génériques. (who.int)
  • À notre avis, la substitution par des génériques ne doit pas être mise en œuvre de manière aléatoire en raison de l'incertitude et des faibles connaissances des patients. (who.int)
  • As reflected by the Danisco launch, research continues to focus on improving product performance of existing products and on the development of novel enzymes for specific niche applications. (foodnavigator.com)
  • Whether you already have a project portfolio, or are starting to build a portfolio from scratch, this breakthrough book will show you how to obtain a high-performing project portfolio without investing in expensive tools. (jrosspub.com)
  • We show that it is possible to grow cells successfully with a completely defined and animal product-free medium," says Stina Oredsson. (lu.se)
  • "I think this is crucial to discriminate one probiotic product from another," ​he said. (nutraingredients.com)
  • Ulf Brøchner Sørensen, global product manager bakery enzymes, told FoodNavigator.com that this collaboration has given Danisco much more access to R&D power. (foodnavigator.com)
  • The new products will power the upcoming Aurora supercomputer at Argonne National Laboratory, with updates on its deployment shared today. (intel.com)
  • The Chinese herb Artemisia annua has been found to be effective against resistant malaria and could create a breakthrough in preventing almost 1 million deaths annually. (who.int)
  • In particular, the Type B meetings described, including the pre-IND, end-of-phase and pre-BLA meetings, represent critical points in product development. (fda.gov)
  • Our annual survey of ideas and trends that will make an impact on business: Elizabeth Warren and Amelia Tyagi believe consumer credit should be made as safe as any other product. (hbr.org)
  • A cluster-associated case was defined reaction (RT-PCR) cycle threshold (Ct) values in specimens as receipt of a positive SARS-CoV-2 test (nucleic acid ampli- from 127 vaccinated persons with breakthrough cases were fication or antigen) result 14 days after travel to or residence similar to those from 84 persons who were unvaccinated, not in the town in Barnstable County since July 3. (cdc.gov)
  • COVID-19 fully vaccinated, or whose vaccination status was unknown vaccine breakthrough cases were those in fully vaccinated (median = 22.77 and 21.54, respectively). (cdc.gov)
  • In many cases, these are paid actors, but even if they are real, such stories do not prove a product works. (medlineplus.gov)
  • Breakthrough is a fast paced roguelike-shooter with high-risk high-rewards mechanics. (steampowered.com)
  • Some of the products and information on this website may only be applicable in the United States. (agelessway.org)
  • Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. (cdc.gov)
  • In advance of Supercomputing '22 in Dallas, Intel Corporation has introduced the Intel Max Series product family with two leading-edge products for high performance computing (HPC) and artificial intelligence (AI): Intel® Xeon® CPU Max Series (code-named Sapphire Rapids HBM) and Intel® Data Center GPU Max Series (code-named Ponte Vecchio). (intel.com)
  • "Cell surface proteins such as Lp_2940 for which the functional properties are currently unknown are among a growing repertoire of Lactobacillus cell products providing specific contributions in the mammalian gut, which are not related to host diet," ​ wrote the researchers. (nutraingredients.com)
  • Whether a hardcore gamer looking to up their game, a family historian preserving precious memories, or a photographer capturing the right shot, the new products are designed to provide world-class reliability and performance to keep up with consumers' evolving data storage needs. (westerndigital.com)
  • Intel Max Series Brings Breakthrough Memory Bandwidth and Performance. (intel.com)
  • There are major changes in cell surface properties, said Prof Kleerebezem, and the new study showed that the form of the probiotic perceived by the intestinal mucosa may not be the same as the form of the probiotic added to the food product. (nutraingredients.com)
  • Both balanced and very difficult, Breakthrough will conquer the heart of thoses seeking a great challenge. (steampowered.com)
  • Other than that, it is a great product. (mountsplus.com)
  • We have developed a completely animal product-free cell medium and it worked immediately - we could repeat with great precision. (lu.se)
  • Sign up for our newsletter and receive discounts, advanced notice of releases, product updates, and more! (soccerpro.com)
  • More than one-quarter report often arriving at product detail pages from social media. (marketingcharts.com)
  • Fisheries and level playing field remain (as expected) the sticky issues in which no real breakthroughs were expected this week. (politico.eu)
  • Get full access to What Sets Breakthrough Strategies Apart and 60K+ other titles, with a free 10-day trial of O'Reilly. (oreilly.com)