What You Should Know:
- The U.S. Food and Drug Administration (FDA) has recently issued several key clearances, marking significant advancements across diagnostics, surgery, and remote patient monitoring.
- These FDA clearances reflect a deepening integration of Artificial Intelligence (AI) and advanced technology into clinical workflows, promising greater precision, reduced invasiveness, and expanded access to care.
Diagnostics and Remote Monitoring: AI and Wearables at Scale
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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant
Navigating FDA’s New Guidance on Medical Device Servicing
The complexity and cost of medical devices are escalating, and with it, the stakes for maintaining these assets efficiently and compliantly are increasing. In some cases, this requires complex and comprehensive repairs that may involve major components of the asset being rebuilt or upgraded. As organizations strive to prolong the safe, useful lifespan of their medical assets while curtailing capital expenditure, they face a new challenge: adhering to the U.S. Food & Drug Administration’s
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FDA Forms Digital Health Advisory Committee
What You Should Know:
- The U.S. Food and Drug Administration (FDA) has formed a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software.
- The Digital Health Advisory Committee will advise the FDA on issues related to DHTs,
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FDA Selects Ontada to Investigate Rare Cancers Treated in US Community Oncology Setting
What You Should Know:
Ontada, announced it was awarded a competitive contract with the U.S. Food and Drug Administration (FDA) to advance the use of real-world data (RWD) in the U.S. community oncology setting.Ontada will conduct real-world research (RWR) that aims to strengthen the scientific understanding of the natural history of rare cancers by leveraging Ontada’s community oncology footprint and unique RWD.
Study Goals & Objectives
The goal of the study is to
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FDA Taps Flatiron for 5-Year Real-World Data Collaboration
What You Should Know:
Flatiron Health today announced its renewed collaboration with the Oncology Center of Excellence (OCE) of FDA to jointly develop and implement specific research projects to advance the use of Real World Data (RWD) and explore the potential strengths and limitations of using Real World Evidence (RWE) for regulatory purposes.The partnership will specifically evaluate RWD study designs and analytic methods through the collaborative development of priority, clinically
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FDA Clears Samsung’s Irregular Heart Rhythm Notification
What You Should Know:
Today, Samsung announced today its Irregular Heart Rhythm Notification feature of the Samsung Health Monitor App has been cleared by the FDA. With this new feature, Galaxy Watch users can be alerted when heart rhythms suggestive of atrial fibrillation (AFib) – a type of arrhythmia – are detected.The Irregular Heart Rhythm Notification works with the app’s existing on-demand Electrocardiogram function to proactively monitor heart rhythms suggestive of AFib, and
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Healthy.io Secures $50M to Expand Smartphone Kidney Test
What You Should Know:
Healthy.io, the global leader in transforming the smartphone camera into a clinical-grade device, raises $50M in a Series D funding round led by Schusterman Family Investments and is joined by Aleph and other existing shareholders. This investment, together with a previously unannounced $45 million February 2022 investment, comprises the company’s Series D.The Series D round will support Healthy.io’s expansion across the U.S. market, where Minuteful Kidney™, the
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Magenta Medical Raises $55M for World’s Smallest Heart Pump
What You Should Know:
Magenta Medical, the developer of the world’s smallest heart pump, announced today a $55M financing round led by global healthcare investment manager OrbiMed, with participation from existing investors New Enterprise Associates (NEA), Pitango VC, and ALIVE - Israel HealthTech Fund.The financing will be used, among other things, to advance the clinical programs of the company’s product in the United States toward its first FDA
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Sanofi & Flatiron Health Partner to Redesign Clinical Trial Experience for Sponsors
What You Should Know:
Flatiron Health announced a new partnership today with Sanofi in their pursuit to redesign the clinical trial experience for sponsors, sites, and patients in the therapeutic area of oncology. The multi-study partnership between Sanofi and Flatiron will focus on improving clinical trial data acquisition, delivery, and quality through site-facing technology that digitally transfers data captured in the electronic health record (EHR) directly into the electronic data
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MedCrypt Funds Medical Device Usable Security Research at Tufts University
What You Should Know:
- MedCrypt, Inc., a proactive cybersecurity solutions provider for medical device manufacturers, announced its financing of the School of Engineering for a Tufts University fellowship program that will support research focusing on the investigation of medical device security and threat modeling.
- MedCrypt acknowledges the vital role that evidence-based security practices play in the MedTech industry and recognizes the need to address the existing gaps. Additionally,
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