Hepatitis, Infectious Canine

RapidAI, a health tech company specializing in imaging analysis software, announced it received FDA 510(k) clearance for its Rapid RV/LV product that aims to speed up the pulmonary embolism triage and care process. Rapid RV/LV analyzes Computerized Tomography Pulmonary Angiograms and calculates the ratio between the right ventricle and left ventricle after a scan. The difference in measurement can be a key indicator of the severity of pulmonary embolism, since about 45% of patients with acute pulmonary embolism will have acute right ventricle failure. The tool is a new addition to the company's pulmonary embolism tools. Its use can be combined with RapidAI's mobile and web apps dubbed Rapid Workflow and Rapid PE Triage & Notification platform, which analyzes CPTA images and alerts care teams when it finds a suspected pulmonary embolism. "The FDA clearance of Rapid RV/LV further enhances our PE solution by providing physicians with an immediate view into patients suffering from RV strain, which is critical to getting the right patients to the right care as fast as possible. This is yet another step toward delivering AI-based solutions that help physicians further enhance patient care and impact patient outcomes to ultimately improve quality of life – something we are very proud to be part of," Karim Karti, CEO of RapidAI, said in a statement. THE LARGER TREND After years of steady decline, the number of individuals who died from pulmonary embolism began increasing year over year, with the biggest increase in premature deaths occurring among those 65 years of age and younger. RapidAI, also known as iSchemaView, has several FDA 510(k) clearances, according to the FDA's database. Some of its FDA 510(k) clearances include: Its Rapid ASPECTS device that helps physicians detect brain injuries and determine if a patient is eligible for a thrombectomy. Its Rapid Hyperdensity platform, which allows physicians to assess the severity of injury in patients with acute neurological conditions like brain hemorrhages and traumatic brain injury. Its updated intracranial hemorrhagic management tool Rapid ICH. In 2020, the company garnered $25 million in Series B investment and acquired cerebral aneurysm management platform EndoVantage.

The imaging programme uses AI algorithms to detect probable large vessel occlusions on NCCT images and computed tomography angiography Methinks has received CE mark for its Methinks Stroke Suite imaging software. (Credit: Milad Fakurian on Unsplash) Digital health Company Methinks has received a CE mark for its medical imaging software, Methinks Stroke Suite, designed to help in emergency settings for the benefit of acute stroke (AS) patients. Methinks Stroke Suite is said to be the first CE-marked medical device that is capable of finding large vessel occlusions (LVO), both hyperdense and not, from non-contrast computed tomographies (NCCT) images. Methinks, which is based in Barcelona, Spain, has designed the radiological computer-aided triage and notification system to detect suspected LVO on NCCT images as well as on computed tomography angiography (CTA). The software, which uses artificial intelligence (AI) algorithms, can also detect intracerebral haemorrhages (ICH) on NCCT images. According to the digital health company, the programme triages AS patients early, quickly, and precisely by operating in parallel with the clinical workflows. It uses CT scans that are available in all hospitals for AS. Methinks CEO Pau Rodriguez said: “We are delighted with the CE mark approval for our medical imaging software, Methinks Stroke Suite, which paves the way to enhance stroke patient outcomes by decreasing detection time and reducing disabilities. “Our software has the potential to be used in every hospital globally to improve the standard of care of patients. “The approval comes at a pivotal time ahead of US FDA submission and launching a series A financing to accelerate our growth plans by leveraging and personalising imaging software.” Additionally, Methinks Stroke Suite can help qualified doctors support critical care and triage in emergency cases by informing them of suspected ICH and LVO cases. Its ability has been validated in 3,800 cases from three separate stroke reference hospitals. Methinks said that the CE-mark certification will enable the commercialisation of the stroke triage software in Europe. The Spanish digital health company is involved in the development of AI-based medical imaging software to identify cerebral artery occlusions and haemorrhages.

DUBLIN, Feb. 21, 2023 /PRNewswire/ -- The "cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA" training has been added to ResearchAndMarkets.com's offering. GMP-compliance is a must for manufacturers of finished pharmaceutical products and active pharmaceutical ingredients (APIs) according to the different national legislations. The related GMP rules are typically valid for one country based upon the anchoring in the respective national laws. However, at the same time the GMP rules are more or less internationally harmonized such as e.g. the ICH Q7 Guidelines representing the "Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients" being adopted by the regulatory bodies of the European Union (EU), Japan and USA. Why Should You Attend It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science". Yet GMPs have been enshrined into law for many countries and a drug/biologic/medical device manufacturer should have a reasonable expectation of all inspections being the same. ICH Q7 was established by US / EU and Japan to harmonize inspections in their respective countries. This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.. After this event, you will be fully prepared for cGMP regulatory inspections in those countries. Who Should Attend: Manufacturing Quality Control Quality Assurance Senior Management Project Managers Qualified Persons (QPs) Regulatory Compliance CMC Personnel Packaging Experts Auditors and Staff IT Subject Matter Experts Key Topics Covered: Session 1: U.S., EU, and Japan GMPs - Status of Harmonization& Future Trends Current status of harmonization of GMP requirements Future Trends Where Inconsistencies Become a Problem: WHO, ICH, Countries Discrepancies in global expectations Alignment issues Key Chapter Reviews ICH GMP organization Category reviews Compliance with ICH Guidelines for GMPs Understanding and Insight into Healthcare Authority expectations How GMP requirements/inspections can differ with a single ICH Standard How regulators (from 3 regions) will assess/enforce compliance with Q7 Session 2: APIs Auditing API facilities Typical audit agenda ICH Area differences Finished Products Auditing finished product facilities Typical audit agenda ICH Area differences Excipients Sterile products Biologics Clinical Packaging Session 3: Area GMP Inspections Differences on how GMP inspections are conducted Areas of GMP inspection focus by area Modifying your self-inspection systems to customized area concerns Outsourcing Management Regional Perspective on: Contract manufacturing Contract packaging. 3rd Party Contract testing Auditing Your Facilities for Global Considerations Importance of pre-audits to regional GMP focus. How to focus your internal audits to a US, EU and Japan compliance system. Speakers: Kelly Thomas Vice President Stallergenes Greer Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries. For more information about this training visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets