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Riding the wave of innovation: How to secure 4 FDA clearances and 2 FDA Breakthrough Designations in 4 years In conversation with Dr Gary Woodward, Chief Product Officer, Ultromics, we cover: 💙 Gary's Journey to CPO 💙 How regulations have evolved in #AI + #Healthcare 💙 How Ultromics has navigated these 💙 4 clearances (+2 breakthroughs) in 4 years 💙 Other FDA clearances in the space 💙 What's next Updated AI Echo Market Diagram now including Kosmos by EchoNous and Ventripoint Diagnostics Ltd. Plus new entrants: iCardio.ai and InvisionAI GE HealthCare, Philips, FUJIFILM Holdings America Corporation, Canon Medical Systems Corporation., Siemens Healthineers, Butterfly Network, Inc., Clarius Mobile Health, Exo, Caption Health, UltraSight, HeartLab, Us2.ai, ThinkSono, American Society of Echocardiography, American College of Cardiology, Johnson & Johnson Innovative Medicine, Pfizer https://lnkd.in/eDRbW3SY

Recommended reading for those interested in the #AI #echocardiography market. ⬇ #medtech #healthtech

It was great to take the time to talk to Ross Upton, PhD to share a glimpse into our journey at Ultromics. From serendipitous coffee shop meetings to pioneering AI-driven echocardiography solutions, the journey has been nothing short of extraordinary and I am immensly grateful. Alongside a brilliant team, we've navigated the evolving landscape of AI in healthcare, securing four FDA clearances and two breakthrough designations in just four years. As CPO, I've had the privilege of blending science with strategy, steering our products from conception to market, and paving the way for groundbreaking advancements in cardiac care. For me, AI is not just about developing topical technology, but has been a tool amount many in pursuit of crafting a future where early and accurate diagnosis of disease becomes the norm, not the exception. The road ahead is bright, filled with potential for further innovation and collaboration across the healthcare ecosystem. Let's always continue to push the boundaries of what's possible. #AI #HealthcareInnovation #CardiacCare #Echocardiography #Ultromics

In the realm of medical innovation, we're rethinking the journey from bench to bedside. Traditionally, the journey from bench to bedside has been viewed as a linear process, moving from basic research to clinical application. A circular approach, navigating from bench to bedside and back, promises to revolutionize scientific translation into clinical practice. Adopting the circular approach involves reevaluating traditional research models, investing in interdisciplinary collaboration, and placing patient engagement at the forefront of the research process. Check out my latest article for detailed insights—I'd love to learn and discuss more on this topic! On a side note: I'm eager to explore #opportunities within the #preclinical and #clinicalresearch domains, particularly those that prioritize patient-centric drug development. I would love to be a part of a team that is truly committed to #translationalresearch, and values #continuouslearning and #sharing knowledge. Lets together connect scientific research to #healthcare. #ScientificTranslation #CircularApproach #TranslationalResearch #PatientCentricity #bench_to_bed_and_back

This week, industry players are pushing boundaries, from Astellas Pharma adapting its GA drug strategy amidst regulatory pushback to Aignostics advancing #AI in pathology through new funding. Key players like Oracle Health and FirstHealth of the Carolinas are changing the future of patient data exchange and remote care, highlighting a shift towards greater efficiency and patient-centered models. On the tech front, eClinicalWorks and Scott Gottlieb spotlight AI's expanding role in diagnostics and clinical workflows, though challenges like language biases in models like ChatGPT underscore the need for equity and accuracy. Philips and HOPO Therapeutics showcase AI’s real-world impact with military health monitoring and BARDA-backed drug development, pushing the boundaries of predictive care and public health preparedness. Ottimo Pharma’s high-profile launch, AbbVie’s acquisition moves in #Alzheimer’s, and Biogen’s progression in kidney disease treatments demonstrate that companies are capitalizing on emerging therapies and market recovery trends, powered by financial boosts and regulatory approvals. And as healthcare intersects with policy, Mark Cuban’s insights on #PBM reform signal potential changes in drug cost transparency, echoing a broader call for equitable healthcare access. Stay on top of these developments as they shape the future of healthcare. 👇

Investment in precision medicine is reshaping the healthcare landscape. 🚀 From reducing long-term healthcare costs to driving job creation, the benefits of precision medicine are clear. As big pharma and venture capital firms increasingly invest in this space, it’s crucial that policymakers support these efforts with updated reimbursement models and supportive frameworks. Learn how precision medicine is transforming the economy and the future of healthcare in our new blog post.👇 https://lnkd.in/eUqArsnc #PrecisionMedicine #Genomics #HealthPolicy

A collection of recent progress in Biomedical R&D, MedTech/BioTech industry, Regulations and Standards, and healthcare technology related to various applications shaping the future of healthcare, mainly in Sept. 2024. Some key highlights included in the link: - A decade of cancer immunotherapy: Keytruda, Opdivo and the drugs that changed oncology - Exact Sciences wins US FDA approval for Cologuard Plus colorectal cancer test - Senseonics, Incorporated receives FDA clearance for one-year CGM - Multiple progress in the development of ctDNA-based molecular/minimal/measurable residual disease (MRD) and show survival evidence in resectable colorectal cancer - Congress again delays steep cuts in Medicare lab payments - Lab group urges lawmakers to rescind FDA final rule on LDTs and FDA hosted webinar to discuss the final rule - FDA official discusses agency’s new Rare Disease Innovation Hub - Many FDA-authorized AI devices lack validation data - IMDRF prepared to release an update to Medical Device Software: Considerations for Device and Risk Characterization - Senators introduce bill to set healthcare cybersecurity standards - FDA Authorizes First Over-the-Counter Hearing Aid Software - Startup from George Church’s lab raises $75M to develop ‘supercell’ medicines - Bristol Myers Squibb sets out to sell first-of-its-kind schizophrenia drug - Summit lung cancer drug shows ‘striking’ benefit over Keytruda - House backs bill restricting China role in US biotech - FDA official calls for mandatory reporting of device shortages - SetPoint Medical Receives FDA’s IDE Approval for U.S. Pilot Study of Neuroimmune Modulation Platform in Adults with Relapsing-Remitting Multiple Sclerosis - Synchron’s brain-computer interface tech meets safety goal - Medicare tweaks rules for second round of drug price talks - Dexcom, Abbott OTC glucose sensors add to busy year for diabetes tech - World Health Organization approves Abbott molecular mpox assay under the agency's Emergency Use Listing (EUL) procedure - Neuralink gets FDA's breakthrough device tag for 'Blindsight' implant - Why Digital Health Startups Should Start Thinking About Their Reimbursement Pathway Earlier - Gene therapy startup emerges with green light for first-of-its-kind trial - and more! #biomedicalengineering #precisionmedicine #digitalhealth #medicaldevices #qualitymanagementsystem #bioinformatics #healthcareinnovation #cybersecurity #healthcaretechnology #pointofcare #POC #healthtech #invitrodiagnostics #samd #simd #regulatoryaffairs #standards #internationalstandards #industrystandards #globalhealth #publichealth #neuralengineering #neuromodulation #neuroscience #bioelectronics #biologics #biopharmaceuticals #biotech #medtech #clia #LDT #IVD #NIST #mpox #liquidbiopdy #healthinsurance #reimbursement #HealthIT #MobileHealth #QualityAssurance #QMS #NGS #Sequencing #OTC #infectiousdiseases #denovoclearance #diagnostictests #breakthroughdesignation #policy #MolecularDiagnostics #PCCP

"The groundbreaking work underway in the development of bio #digitaltwin #technology holds immense promise in both saving and enriching lives...Essentially, the technology involves the replication of the human body in software models. Using these models, #healthcare providers can test drugs and therapies with unprecedented speed and accuracy, reducing risks for both patients and physicians." Read More 👉: https://lnkd.in/gDtMPU8V via CIO Online #digitaltwins #lifesciences #healthtech #medtech #AI #artificialintelligence #medicalindustry #healthcareindustry #pharmaceuticals #pharmaceuticalsindustry #biotech #investing #investinginhealthcare #futureofhealthcare #venturecapital #capitalmarkets #healthcarestocks #aistocks #quantumcomputing #trenchanttechnologies #trenchanttechnologiescapital #trennchantcapital #aitt

In the healthcare value chain, laboratories, clinicians, researchers are all key players - but one should never forget that every research and development effort, every minute of our attention should focus on patients. It is now well known that, when hospitals are, on average, spending less than 4% of their budget on diagnostics, at very least > 70% of the medical decisions taken for a given patients are impacted by a diagnostic result. At the same time, the COVID-19 pandemic definitely highlighted the relevance of diagnostics in the healthcare value chain. It also proved that patient care makes tremendous progresses when private and public actors come together and act as one . Proactively and continuously working together to establish consistent standards of accuracy and reliability for every in-vitro diagnostic test , while protecting innovation and speed of developments, is really key to making improvements in life possible.

In this DPHARM: Disruptive Innovations to Advance Clinical Trials webcast, experts from Biofourmis, Advarra, IQVIA, Science 37, and Bayer join Merck's Katherine Taylor to discuss: ▶ Interoperability of technology to lessen burden for sites. ▶ More intentional implementation of technologies for easier patient access. ▶ Harnessing the good, the bad, and the concerning of generative AI for clinical development. ▶ Running a fully remote trial with confidence for patients and investigators. Watch it here: https://lnkd.in/e5gSzzgz I #ClinicalTrials #ArtificialIntelligence #Interoperability #ClinicalTrialDesign #HybridClinicalTrials #DigitalHealth Jaydev Thakkar