Grace Fu Palma

Ultrasound technology enhanced with artificial intelligence (AI) improves the precision and interpretability of ultrasound imaging. This combination brings a new dimension to ultrasound's capabilities, making it a more powerful tool for early diagnosis. Acertara's ongoing research and development efforts aim to evolve ultrasound into a predictive tool for preemptive medical intervention. This breakthrough marks a pivotal shift in healthcare, positioning ultrasound as a fundamental driver in preventive medicine. #EarlyDetection #Ultrasound #ArtificialIntelligence Learn how Acertara’s ultrasound technology is pioneering early detection in healthcare. Visit https://bit.ly/3RfNOtp for more information.

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MedTech, a $500 billion industry will more than double as TechMed becomes the new market driver. Alan Cohen, head of the prolific DCVC investment group that is fueling the next generation of medical devices has identified a new segment of the medical device industry, “TechMed”. “Whereas MedTech players are primarily product companies that monetize device sales, TechMed companies are funda­men­tally software- and platform-centric.” “The economics and business-model impli­ca­tions of the TechMed movement more closely mirror the dynamics we see from dominant tech platforms and ecosystems.” Immersive medicine, the use of media as medicine, sits firmly in the TechMed space and will drive considerable job growth for those capable of wielding media to impact change to human health and behavior while generating an amazingly potent data stream. Read all of Alan’s thesis here: https://lnkd.in/gx5BMab2 See him present next at LSI’s awesome medical conference on September 19th (Day 3) at #LSIEurope24 in Sintra, Portugal.

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“3 Peats” are rare “4 Peats” are unheard of… Yet Bill Hunter and his incredibly talented team at Canary Medical Inc. have done just that. The news below related to their spinal fusion technology makes four straight (knee, hip, shoulder and now spine) products which have been granted “Breakthrough Designation” by the FDA. Bill was quoted in the presser as saying that it was an “unparalleled accomplishment in the industry”. That’s putting it mildly. This feat is beyond remarkable. Most great companies are fortunate to have one such pelt for the wall. Much less four! The Digital Health market is very challenging at present. Funding is scarce. So are proven value propositions. However, Canary Medical Inc. serves as a shining example of what is possible in this market when stakeholder interests are strategically aligned around the patient. Something tells me (perhaps a little birdie???) that this won’t be the last we hear from Canary Medical Inc. either. The potential applications for their data driven solutions are endless. THIS is the future of medicine. 👏

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Key takeaway from MedTech MVP's "Breakthrough Device Panel Discussion": "While patient impact is advanced by improved times for novel devices (via the De Novo or PMA) there remains opportunity. The 510(k) is the most common application type and the "workhorse" for medtech innovation. Here we can stand to get more innovative solutions." #medtechmvp #breakthroughdevices #510kpathway #denovo #thoughtleadership #conferencerecap

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Thank you very much for your support, Ken Washington, PhD! As I admitted in the episode, speaking with Rodolphe Katra, PhD, MBA, was one of my favorite interviews I've ever had the privilege of conducting! I was also inspired by Medtronic's AI Compass and the thoughtful approach Medtronic is taking to leverage #AI for better #MedTech outcomes. Thank you again for your kind words and share! #artificialintelligence #medicaldevices #podcast #videopodcast #womeninmedtech

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Value-based care (VBC) represents a significant shift in healthcare, focusing on outcomes rather than procedures. Ultrasound technology is instrumental in this transition, offering high-quality diagnostics while controlling costs. Here’s what providers need to know: • The VBC approach prioritizes patient outcomes and cost efficiency. • Ultrasound in VBC is essential for accurate, timely, and cost-effective diagnostics. • Acertara's R&D is advancing ultrasound technology and enhancing patient care. • Our partnership and collaboration with healthcare providers, leaders, and institutions drive new innovations. • Ultrasound is critical to effective, efficient, and progressive healthcare delivery. At Acertara, we’re focused on integrating ultrasound solutions into the VBC framework, aiming to improve patient outcomes and contribute to the sustainable future of healthcare. #Ultrasound #ValueBasedCare #HealthEquity Partner with Acertara for ultrasound-powered value-based care. Visit https://bit.ly/3RfNOtp

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Spine Deshittification (Thank you Mitch Johnson for coining the phrase) In 30+ years in this crazy business, I have never worked in spine.  Some customers are actually brain surgeons – and the surgical technology reflects it – VR, robotics, navigation. Yet “workhorse” devices, upon which outcomes often depend, have had little recent R&D investment. This hasn’t gone unnoticed. A prominent spine surgeon told me, “There are a shed-load of interbody cages with no evidence that any one product or approach is superior to another. In our health system, we will move to a ‘generic’ platform because we can’t justify increased expense for ‘proprietary” devices. In 2-3 years, devices will be off the market unless they clearly demonstrate a value proposition.” In the last 5 years, better battery chemistry and low power sensors have allowed Canary to significantly shrink our CHIRP implant. We can now create a “cartridge” suitable for insertion into interbody cages in a manner similar to cementless knee, hip and shoulder products under development with Zimmer Biomet. ALL of these devices have received FDA breakthrough designation. Heel strike during walking sends a shockwave through the skeleton. Accelerometers, gyroscopes and step counters implanted in the disc space can measure and quantify activity (step count, cadence, walking speed, stride length, distance); at high fidelity (3200 observations/second) they can detect subvisual spinal segment movement (range of motion, gait, vibration). The object is to confirm lack of spinal segment movement (fusion), as opposed to increased movement (ROM) for Persona IQ knee patients. Algorithms can be developed to quantify and stratify (5th to 95th percentile) normal/abnormal patient activity and interbody kinematic metrics obtained daily during recovery; sort and filter algorithms can identify “outliers” and alert care teams to individuals needing enhanced, personalized care. Individualized physiotherapy, exercise programs, and therapy guided by objective data can help patients recover better and faster – at home remotely. Machine learning applied to the generated data set can search for potential complications (subsidence, infection, painful gait, DVT, etc). Rich, objective, post-operative data can be combined with rich, interoperative data to inform everything from patient selection and surgical technique to implant design. (Apologies if you have heard this before) Spine surgeons are anxious to have objective data: 87% would use this technology if it was available; only 6% were “somewhat” negative; the best acceptance rates I have seen for a novel device concept. Canary plans to make this technology widely available, either by making a “generic” interbody cage to deliver CHIRP-lc, or by working with existing manufacturers to modify their devices to accept a “smart” cartridge. If any company is willing to go first and invest, let me know - you can get a couple of years’ head start!

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The Project Medtech Podcast : Episode 182 with Andrew Fish and Joseph Sapiente at Medical Device Innovation Consortium (MDIC) is now available. In this episode, Andy, Joe and Duane Mancini, M. Sc. discuss the mission of MDIC, the various initiatives and programs, how to engage MDIC and so much more. Links to the podcast, monthly newsletter, and website are in the comments below! Follow Project Medtech on LinkedIn for more great content or visit our website #medicaldevices #startup #medtech #projectmedtech #innovation #medicaldevice #podcast #strategy

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Medable, Inc and Masimo partner to bring wearables to clinical trials Daniel Cantillon M.D. medical officer at Masimo, said: “Clinical trials require top-in-class accuracy and data quality both on-site and off-site from clinical offices. Medable is solving this problem through its advocacy and by empowering more patients to participate in research. Medable’s flexible platform enables scalability and data aggregation for a holistic approach.” Musaddiq Khan, Medable’s vice president of Digital Outcomes, said: “Masimo’s SET pulse oximetry is sensitive enough to capture key vitals on the very ill like cancer patients, plus it works on all skin tones, all ages, and is easy to use" - https://lnkd.in/d-Kf2TvZ #medicaldevice #medtech #wearables #wearabletech #clinicaltrials

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ASCdx Highlights #4 Geography: Non-Exclusive Territories Traditionally, exclusive territories have been a contention point for sales reps when negotiating contracts. ☝️ They often fight hard to maintain the “rights” to function as the exclusive representative for a particular company in a small defined geography. While there may be advantages in this scenario, based on market share, it can work to limit long-term growth potential. 📈 By forgoing the traditional exclusive territory route, the marketplace is opened to pursue business nearly anywhere. 🗺️ #ascdx #medicaldevicebroker #orthopedics

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Another good medtech strategy article. A centralized, searchable resource for global medtech regulations is a game-changer. Here are two key benefits: 1. Easier access to documents streamlines the approval process, potentially accelerating time to market for critical devices. 2. A clearer understanding of global regulations can fuel innovation in underserved markets, improving access to healthcare technologies. #MedTech #Policy #GlobalHealth https://lnkd.in/gJWTMQPb

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Another insightful FREE webinar on the topic of Medical Device Design Controls coming up later this month! Learn more and register below.

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If you know me you know Mark Wehde. We work together on the Medical Device Innovation MS Degree Program at the Technological Leadership Institute, University of Minnesota. Here is a insightful article by Mark on the program!!

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Register to get the recording of this important webinar! Join @GE HealthCare and @Frost & Sullivan on May 2 to see how the cloud is redefining the management, storage, and use of imaging data, and why healthcare organizations are shifting to the cloud. “What’s with the shift to cloud-based imaging?”, features Daniel Ruppar, Consulting Director, Healthcare & Life Sciences Frost and Sullivan. We'll discuss how to think about enterprise imaging from a patient perspective and steps to creating the right strategy for moving your imaging to the cloud.

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Orthopedic tray consolidation is the best process to add efficiency and cost savings to a facility! The question becomes who performs and is responsible for the consolidation (facility/rep/OEM). Hint, it should not be the rep independently. If completed how is this set sterily verified in this new configuration and what paperwork is needed to support? Tough questions. We have made it easy with pre-validated/FDA cleared joint systems. Plug and play...no easier way to dramatically increase efficiency, implement real cost savings ($200+/case) and lessen the reliance on OEM set management.

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Our team will present: Navigating Medical Device Registration in Asia: Beyond China Time: Thursday, Oct 10, 2024 | 11:00 am-12:00 pm EST 🌍 This session aims to provide a comprehensive exploration of navigating the intricate regulatory landscape in the East and Southeast Asia region beyond China, offering strategic insights and practical approaches for achieving successful market access. With diverse regulatory frameworks, cultural nuances, and varying compliance requirements across countries, businesses face unique challenges. This session will equip attendees with the knowledge and strategies necessary to navigate regulatory hurdles and optimize market entry. 📍 Introduction to Regulatory Environment: Overview of the regulatory landscape in key countries (e.g., Japan, South Korea, Philippines, Thailand, Malaysia, India, etc.) Recent regulatory changes and trends impacting product registration Challenges and pain points in navigating the complex regulatory environment   📍Developing Tailored Regulatory Strategies: Crafting a customized regulatory approach for each market Finding opportunities to harmonize requirements and streamline processes   📍Best Practices for Regulatory Submission: Practical tips for preparing and submitting regulatory documents Streamlining approval processes for faster market entry 📋 Free Registration: https://lnkd.in/e7uWDbDf #medicaldevices #IVDs #Regulatoryaffairs #globalmarket #marketentry #webinars

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Our team will present: Navigating Medical Device Registration in Asia: Beyond China Time: Thursday, Oct 10, 2024 | 11:00 am-12:00 pm EST 🌍 This session aims to provide a comprehensive exploration of navigating the intricate regulatory landscape in the East and Southeast Asia region beyond China, offering strategic insights and practical approaches for achieving successful market access. With diverse regulatory frameworks, cultural nuances, and varying compliance requirements across countries, businesses face unique challenges. This session will equip attendees with the knowledge and strategies necessary to navigate regulatory hurdles and optimize market entry. 📍 Introduction to Regulatory Environment: Overview of the regulatory landscape in key countries (e.g., Japan, South Korea, Philippines, Thailand, Malaysia, India, etc.) Recent regulatory changes and trends impacting product registration Challenges and pain points in navigating the complex regulatory environment 📍Developing Tailored Regulatory Strategies: Crafting a customized regulatory approach for each market Finding opportunities to harmonize requirements and streamline processes 📍Best Practices for Regulatory Submission: Practical tips for preparing and submitting regulatory documents Streamlining approval processes for faster market entry 📋 Free Registration: https://lnkd.in/e7uWDbDf #medicaldevices #IVDs #Regulatoryaffairs #globalmarket #marketentry #webinars

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