TeraRecon Receives First-of-Kind FDA Determination
DURHAM, N.C., June 20, 2019 (GLOBE NEWSWIRE) -- Advanced visualization and artificial intelligence (AI) technology provider, TeraRecon, today announced it has successfully completed an FDA regulatory review of its Northstar™ AI Results Explorer, for which the technology and the determination are both firsts-of-kind in the medical imaging industry. Northstar is designed to work alongside the company’s EnvoyAI™ interoperability platform which includes FDA-cleared 3rd party content listed on its EnvoyAI Exchange marketplace. The Northstar determination letter reinforces the company’s commitment to regulatory and quality standards along with transparency in the field of medical imaging artificial intelligence.
The Northstar AI Results Explorer provides an engaging physician user experience which can be integrated into the clinical systems already used throughout the health enterprise. Now with full commercial availability, Northstar can provide physicians an important way to accept, reject, and interact with AI-derived findings. Through the EnvoyAI marketplace, health systems can enter into a single contractual agreement and confidently run algorithms interchangeably, with a single two-hour software installation.
EnvoyAI is the world's first AI marketplace and the only AI interoperability platform. EnvoyAI customers currently have access to over 80 algorithms with 20 holding regulatory clearances in various global territories.
“As the medical AI market continues to mature, global regulatory bodies are growing ever more vigilant and confident in assessing these emerging technologies,” noted Patty O'Brien, Vice President Regulatory Affairs at TeraRecon. “It is gratifying to work in today’s collaborative regulatory environment and to do our part as an industry partner in the process.”
With deep domain expertise involving class II medical imaging software devices, TeraRecon maintains stringent processes, documentation and quality systems across its design, development and business operations. The FDA has determined that the Northstar AI Results Explorer is exempt from Class II premarket notification requirements and therefore is considered a Class I medical device alongside their existing Class I EnvoyAI platform.
“TeraRecon technologies are always designed keeping their future value in mind,” said Jeff Sorenson, TeraRecon CEO. “We know that our artificial intelligence solutions are only the tip of the transformation iceberg and that workflows will only grow more sophisticated over time. Product requirements will continue to evolve and become deeply clinical and highly specialized, requiring much more than just a marketplace to deliver them. We expect any advanced AI workflow solutions will require the same level of diligence and sophistication as advanced visualization solutions do today, if not more,” said TeraRecon CEO, Jeff Sorenson.
TeraRecon technologies including the EnvoyAI platform, TeraRecon Northstar AI Results Explorer, and its flagship iNtuition™ advanced visualization solution, will be on display at the Society for Imaging Informatics in Medicine (Book a demo at SIIM) in Aurora, Colorado from June 26th – June 28th, 2019. Online demonstrations are available by contacting TeraRecon at email@example.com.
About TeraRecon (www.terarecon.com) TeraRecon is a leader in medical advanced visualization and artificial intelligence solutions. Their flagship product, iNtuition, consistently leads the advanced visualization category of the industry’s leading independent technology analyst. The company continues to innovate ahead of customer demand and has most recently developed new sophisticated healthcare-focused artificial intelligence platform solutions unlike any in the world today. EnvoyAI was the recipient of the prestigious Aunt Minnie 2018 Best New Radiology Vendor award. TeraRecon’s Northstar AI Results Explorer is the first and only enterprise-wide solution capable of delivering AI imaging insights directly and interactively into the systems clinicians use every day. As a company with a 20-year history of innovation, TeraRecon’s mission is to continuously redefine medical advanced visualization and leverage artificial intelligence to improve patient care.
Press Inquiries US: 1-650-372-1100 | firstname.lastname@example.org
TeraRecon, iNtuition, EnvoyAI, and Northstar are trademarks of TeraRecon, Inc.
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
CrossAmerica Partners LP Maintains Quarterly Distribution18.7.2019 22:30:00 CEST | Press release
•Quarterly distribution of $0.5250 per unit attributable to the second quarter of 2019 Allentown, July 18, 2019 (GLOBE NEWSWIRE) -- CrossAmerica Partners LP Maintains Quarterly Distribution Quarterly distribution of $0.5250 per unit attributable to the second quarter of 2019 ALLENTOWN, PA (July 18, 2019) – CrossAmerica Partners LP (NYSE: CAPL) announced today that the Board of Directors of its general partner has approved a quarterly distribution of $0.5250 per unit attributable to the second quarter of 2019 (annualized $2.10 per unit). The distribution attributable to the second quarter is payable on August 6, 2019 to all unitholders of record on July 30, 2019. CrossAmerica will host a conference call on August 6th at 9:00 a.m. Eastern Time to discuss second quarter earnings results, which will be released after the market closes on Monday, August 5. About CrossAmerica Partners LP CrossAmerica Partners is a leading wholesale distributor of motor fuels and owner and lessor of real esta
Building the Tigo of the future18.7.2019 22:07:00 CEST | Press release
Building the Tigo of the future Luxembourg, July 18, 2019 Millicom Chief Executive Officer Mauricio Ramos commented: “We made significant progress on a number of strategically important fronts during Q2. First, we delivered solid quarter of growth in KPIs, especially HFC customer relationships, where our organic net additions are approaching 100,000 per quarter. Second, the integration of Cable Onda is progressing very well, and we now expect that Panama OCF for 2019 should surpass our initial expectations by about 10%, thanks mostly to procurement and other cost savings. We are well prepared to add mobile operations to our Panama operations later this year. Third and finally, consistent with our strategy of re-deploying capital from Africa to Latin America, we completed the disposal of our operations in Chad, and we closed our acquisition in Nicaragua. Although the current macroeconomic environment in Nicaragua presents challenges, we are excited about the long-term growth opportunity
ProMIS Neurosciences Highlights Data for PMN310 at AAIC 201918.7.2019 21:00:00 CEST | Press release
Alzheimer’s Association International Conference includes oral session on PMN310 for Alzheimer’s disease and poster presentation on ALS TORONTO and CAMBRIDGE, Mass., July 18, 2019 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, presented data today for its lead clinical candidate, PMN310 for Alzheimer’s disease, at the annual Alzheimer’s Association International Conference® (AAIC) in Los Angeles. In an oral presentation, Chief Development Officer Dr. Johanne Kaplan highlighted the therapeutic potential of PMN310 against the toxic oligomer form of amyloid beta (AßO), a root cause of Alzheimer’s disease. The presentation is now available at www.promisneurosciences.com. Additionally, Chief Scientific Officer Dr. Neil Cashman presented data pertaining to the company’s preclinical developme
GAM Holding AG: Invitation to Half-year 2019 Results18.7.2019 17:01:00 CEST | Press release
Online version Presentation for media, analysts and investors Tuesday, 30 July 2019 | From 8:30 (CEST) | Zurich Dear Sir/Madam, We cordially invite you to join the presentation of GAM’s half-year 2019 results which will be held via webcast exclusively and which will take place as follows: Programme Date: Tuesday, 30 July 2019 Time: 8:30am CEST (7:30am GMT, 2:30am EST) Web location: www.gam.com The results will be presented via webcast by Group CEO David Jacob and Group CFO Richard McNamara. To join the online presentation, please complete the registration form. The webcast link will be made available on www.gam.com. Please note that there will be no facility to ask questions via the webcast but only via telephone dial-in. You will need to log in and register prior to the event. Detailed information on the half-year 2019 results of GAM Holding AG will be available on www.gam.com from 7:00am CEST on Tuesday, 30 July 2019. To listen in to the presentation by telephone: UK Free Phone 0800
Banks net position in the Riksbank18.7.2019 16:44:00 CEST | Press release
JUL 18, 2019 SEK MILLION LENDING BORROWING 249
Hiab secures its biggest ever commercial order18.7.2019 13:30:00 CEST | Press release
CARGOTEC CORPORATION, PRESS RELEASE, 18 JULY 2019 AT 2:30 PM EEST Hiab, part of Cargotec, has signed a record-breaking agreement to supply MOFFETT M8 55.4 NX truck mounted forklifts with five year ProCare Essential service contracts and equipped with HiConnect for each unit, with one of the largest home improvement chains in the USA. The total order value is over EUR 60 million. In the second quarter, EUR 31 million was booked in the order entry with EUR 29 million booked for the third quarter. This is Hiab’s largest ever commercial deal and ProCare contract agreement, as well as the biggest single order for the Truck Mounted Forklift Business Line. Deliveries are expected to start in the third quarter 2019 and continue until May 2020. When complete, the customer will have updated a significant portion of their fleet with new connected equipment. This will enable them to collect data from a substantial part of the fleet to improve productivity, safety and get service alerts based on ac