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An Abbreviated New Drug Application (ANDA) is an application submitted to the U.S. FDA to demonstrate that a generic drug is equivalent to a previously approved Reference Listed Drug (RLD) in terms of safety, efficacy, and quality. The ANDA contains information used for the review and approval of a generic drug product, and does not typically require preclinical and clinical trial data, but ...
SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and a global leader in data-driven medicine, today launched the new generation of the SOPHiA DDM™ Platform. The new-gen SOPHiA DDM™ Platform offers a new architecture designed to more efficiently compute large amounts of data at-scale, while elevating customer experience with integrated access to multimodal ...
CanaQuest Medical Corp (“CanaQuest” or the “Company”) (OTC: CANQF), is pleased to announce strategic additions to its executive team with expertise in conducting clinical trials and US FDA drug approval success. The team plans to effectively navigate the regulatory approval process for Drug Candidate, CQ-001 (cannabidiol + proprietary API composition), to treat rare ...
In September 2023, Tempus and AstraZeneca initiated a pilot program to leverage Next to identify this specific care gap at participating provider sites, using AI to scan unstructured clinical data to understand which patients may be eligible for testing based on clinical guidelines, and notifying treating physicians to inform care. ...
ByTempus
Introduction Intraoperative irrigation is a commonly used method aimed at reducing microbial burden by removing tissue debris, metabolic waste, and tissue exudate from the surgical field prior to site closure.1 With the absence of universally established standard of care and robust clinical data, the selection of appropriate irrigation solution remains a topic of debate. Isotonic saline has ...
Caresyntax, the leading vendor of enterprise-scale data-driven surgical intelligence solutions to make surgery safer and smarter, today announced its highlights and achievements of 2023, as the company has continued its strong growth journey. Dennis Kogan, co-founder, and CEO: “Caresyntax celebrated its 10-year anniversary in 2023 and accelerated our journey of innovation and expansion ...
Caresyntax, the leading vendor-neutral surgical data and intelligence platform converging AI-powered software, devices, and clinical services, today announced the launch of Caresyntax Clinical Data as a Service (CDaaS) for Medtech industry partners. ...
The collaboration will leverage a secure infrastructure that is compliant with data privacy, information security, and regulatory concerns across the geographies. ...
Its ARC Innovation Center based in Tel Aviv, Israel will leverage the Caresyntax data-driven surgical intelligence platform to drive foundational improvements across clinical, operational, and financial measures. ...
Speaking about the recent additions to their portfolio of services, Richard James, Executive Vice President and Chief Operating Officer of Vitalograph Clinical Trials says: “We have listened to our Sponsors and developed innovative solutions that help them address real challenges, ones they face every day. Our team has in-depth knowledge of study ...
Intermountain Primary Children’s Hospital First in the Country to Implant this Next Generation FDA-Cleared Device Company Welcomes Vice President of Sales & Marketing, Mark Geiger, Who Lives with Hydrocephalus Anuncia Medical Inc. (“Anuncia” or the “Company”), a Company specializing in advancing innovations for implantable and external cerebrospinal fluid ...
New Subgroup and further analyses from PULSAR, PHOTON and CANDELA provide insights into durability results of extended treatment intervals, patient characteristics as well as efficacy and safety of intravitreal aflibercept 8 mg In total, 18 presentations on aflibercept 8 mg and Eylea (aflibercept 2 mg) reinforce Bayer’s commitment to advancing treatment of patients with exudative retinal ...
ByBayer AG
Daxor Corporation (NYSE: DXR), the global leader in blood volume measurement technology, today announces new data validating the benefits of the Company’s BVA-100 diagnostic in optimizing individualized therapy for heart failure patients. Data were presented at the Technology Heart Failure Therapeutics Conference, which focuses on device and technology-based treatments in heart failure. ...
The HFSA Optimal Medical Therapy in Heart Failure (OMT-HF) program can help your patients achieve their best outcomes. An estimated 6.5 million Americans have heart failure (HF). This year alone another 960,000 will likely be diagnosed with this condition. Chances are several of your patients are in this group. Are they receiving the optimal medical therapy (OMT), that helps them achieve ...
Featured presentations include development compound gadoquatrane, a novel contrast agent for MRI Further research explores potential of AI and digital advances in medical imaging Bayer announced today that new data from the company’s advanced radiology portfolio will be presented at the 2023 European Congress of Radiology (ECR), taking place from March 1-5 in Vienna, Austria. The ...
ByBayer AG
Dr. Ali Tinazli is the CEO of lifespin.health and has 15+ years in Fortune 100 corporate strategy and entrepreneurship (SONY, HP). Obesity rates continue to climb alongside a $254.9 billion global weight loss products and services market. Supplements, smartphone weight loss apps, diet plans and exercise programs are widely available to consumers, yet the World Obesity Federation projects that 1 ...
This KPI can help Biotech companies understand their current status and future goals. 2. Data Generation: Data generated through different studies, publications and presentations impact clinical practices. Current scientific data, best practices, and patient feedback can be a good indicator of key performance. 3. ...
The Covid-19 epidemic has changed the world in many ways, and many clinical trials have been done to research more about it. According to the World Health Organization (WHO), 12,969 clinical trials were done in America in 2021. Even in pre-pandemic times, clinical trials have always been an ongoing process. Clinical trial managers work on cutting-edge studies and contribute to ...
Inspirata Inc. and FUJIFILM Corporation signed an asset purchase agreement for Fujifilm to acquire Inspirata’s Dynamyx® digital pathology technology, employees and customers, building off the proven success of the established partnership between the companies in UK and Europe. This milestone allows the Digital Pathology business to flourish with a partner who has the breadth, depth and ...
Today about 20 cancer treatments approved by FDA and EMA are directed towards specific gene fusions, and the number of drugs available is growing annually. The increased importance of gene fusions in oncology is driving demand from diagnostic laboratories for scalable analytical solutions. RNA can be used to analyze gene fusions. Moreover, while DNA is largely identical in all cells, RNA ...