Joe Sitomer

Inner core with positive mass and outer sphere with negative mass - gravity with zero net mass. https://lnkd.in/gWfJagtN

1

I’m of the opinion that AI, mathematics (e.g. catagory theory), physics(e.g. the interpretation of quantum mechanics, grand unified theory), neuroscience (e.g. human consciousness, and the computability of it) are all connected at the foundational level, and cannot be studied separately. AI can be dumber than a house cat and a threat to humanity at the same time; we will not understand the true potential and peril of AI before we develop a framework of “grand unified theory of human knowledge”.

1

1 Comment

🚀 Enhancing Precision in Medical Procedures: The Future is Here! As we continue to push the boundaries of medical innovation, precision remains at the forefront of our efforts. At ClearCam Inc., we're committed to enhancing surgical outcomes through cutting-edge technology focused on clear vision while operating. Check out our latest blog post, where I dive deeper into how AI is revolutionizing precision in medical procedures. From advanced imaging to personalized health plans, AI is paving the way for safer, more efficient surgeries. #MedicalInnovation #SurgicalPrecision #HealthcareTech #ClearCam #MedicalTechnology

10

The FDA’s recent final guidance on Predetermined Change Control Plans (PCCP) for #AI medical devices provides a practical pathway to integrate continuous learning AI algorithms, a significant milestone toward enabling safe and effective delivery of evolving AI solutions in #healthcare. #Innovation #AIinRadiology #digitalization #digitalhealth #futureofhealth #medtech #AIhealthcare #artificialintelligence

38

The medical device industry has lots of opportunities. We have found that success requires more than a good idea. 💡 This article will help you find and validate market gaps in the medical device space. It's not a roadmap, but by following these steps, you'll increase your chances of getting a medical device to market. 👓 Read the blog now: https://lnkd.in/eQQzfwAr 🖊️Subscribe to our newsletter: https://lnkd.in/evUyav27 #ProductDevelopment #validation #MustRead #blog #medtechman #MedTech

5

I'll be curious to see the specifics on this announced Apple Watch breathing disturbances metric tracking functionality ostensibly for sleep apnea notifications. This will undoubtedly be at minimum 510(k) cleared (or de novo classified depending on the novelty of the device), so the clearance Apple has indicated is forthcoming will be interesting to read. It is also interesting to see the announcement that AirPods are getting into the over-the-counter (OTC) hearing test space with a claimed clinically validated hearing test feature, as well as the over-the-counter (OTC) hearing aid space with a claimed clinically validated hearing aid for mild to moderate hearing loss. These both are FDA regulated products but appear by regulations to be 510(k) exempt (depending on Apple's marketing language), but it will be more clear once the product is actively marketed and FDA registered.

2

2 Comments

Based on what we've seen from the introduction of other technologies (digital and analog) into medicine and other industries over many decades, this is a dialogue/negotiation/argument that we're going to be seeing a LOT of in the coming years: Kaiser's nurses: "Human expertise and clinical judgment are the only ways to ensure safe, effective, and equitable nursing care," stated Cathy Kennedy, RN, a nurse at Kaiser Permanente Roseville (Calif.) Medical Center and a president of the state nursing association. "We know there is nothing inevitable about AI's advancement into healthcare. No patient should be a guinea pig and no nurse should be replaced by a robot." Kaiser management: "At Kaiser Permanente, AI tools don't make medical decisions — our physicians and care teams are always at the center of decision-making with our patients," the spokesperson said. "We believe that AI may be able to help our physicians and employees and enhance our members' experience. As an organization dedicated to inclusiveness and health equity, we ensure the results from AI tools are correct and unbiased; AI does not replace human assessment." I can't comment about the specifics of the deployment of clinical AI at Kaiser Permanente. However, I will say that the future success of healthcare outcomes will depend heavily on a successful negotiation of these differing perspectives between clinical professionals and "the bean counters."

11

2 Comments

Sectors of the medical device industry are experiencing an incredible ramping of complexity that is not native to the market. We are in an early transition period that is showing signals of liability and entrenched thinking that are creating technology and financial liabilities for organizations. Imaging, Navigation, Artificial Intelligence, Robotics, AR / VR. The few organizations that are natively digital and their existence has been spent in hundreds of thousands of hours immersed in asking the questions, gaining the experiences, and acquiring the certainty of the knowledge giving them a head start that may be insurmountable. Being first is important. Being fast is also important. Being first and fast is devastating to the competition. To those that are not digitally native and are seeking to enter these markets, acquisitions of these technologies is certainly a beginning. Beware. Acquisitions are the purchase of product and information. Information is not knowledge. In acquisitions, those with the knowledge often flee. And the acquirer is left with only information and often mistakes it for knowledge. Bring information to a knowledge fight, and you lose. During this period of digital transition and acquisitions, the legacy device firms should consider… -             Starting stand-alone divisions that are independent of the mothership -             Acquisitions should be left alone and aggressively invested in and tribal knowledge should be massively economically rewarded with cash and tools to keep doing what they are doing. -             Stop creating compensation bands around the internal equity of your current structure. Choosing to prioritize salaries to be equitable no longer prioritizes excellence.

382

39 Comments

Is imaging and robotics undergoing a massive change? Imagine an MRI in your office - with a robot that works through the middle of it - real time - to deliver targeted therapies. Bonkers right? That's Promaxo - and their CEO Amit Vohra, PhD, MBA sat down for a podcast - and hear why what he told me is quite mind blowing. Get the full podcast free here >> https://lnkd.in/d84Ct2eG #promaxo #prostate #imaging #MRI #robotics #surgicalrobotics

47

4 Comments

Dr. Ripal Gandhi, M.D., FSVM, FSIR's recent visit to India provided valuable insights into the treatment of pulmonary embolism with the Inari Medical FlowTriever system. I really appreciate his passion for all things VTE during our chats this week as did many physicians across India. As an enrolling site investigator and expert operator, Dr. Gandhi has a great perspective on the just-released PEERLESS study, which demonstrated the efficacy of the FlowTriever system versus catheter-directed thrombolysis (CDT). But there's more! Dr. Gandhi also recently reported a cross-sectional analysis of U.S. healthcare claims data that compared in-hospital outcomes for patients undergoing mechanical thrombectomy for PE. This research found that the choice of device significantly impacts patient outcomes, with the FlowTriever system associated with better in-hospital mortality rates and higher rates of discharge to home compared to continuous aspiration devices. (Here's the link for that study: https://lnkd.in/gYv8wXUY) Thanks again, Dr. Gandhi! Just getting started! Veiva Scientific India Pvt Ltd Veiva Scientific India Pvt Ltd

45

Computer Science, Standards, and Potato Chips: The Winning Combination AAMI announced that I was the 2024 winner of the AAMI Publication Award for Most Informative article. I joined them in the studio at AAMI eXchange and spoke about what it means to receive the award and how potato chips can help us understand IEC 62304, AI and algorithmic bias. URL to Article: https://lnkd.in/d53QXTRu URL to Interview: https://lnkd.in/gC7_Yz25

25

17 Comments

Aren't Digitization and Electronic Messaging supposed to improve productivity? Many have experienced "inbox burden". Researchers have found that medical doctors feel burned out because they have to respond to and act upon all sorts of messages coming into their inbox in Medical Records (EMRs). Doctors feel they spend more time dealing with EMRs than spending time with their patients. How about having other people take EMR notes for them? After all, many feel "they can write the notes faster themselves” because they found that they had to go back and edit the notes. ____________________________________________________________

1

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

10

I've always loved the magic of words. There is something beautiful about the epiphany that comes from tying two ideas together into some form of enlightenment. One of my goals after stepping down as CEO of the company I founded was to start writing. I was encouraged by Sway's new CEO Alex Pettigrew to put all those life lessons into written form to share with others. I hope some of you find value in these words. Follow me on Substack: https://lnkd.in/gURtigMA

20

1 Comment

I’m thrilled to announce our 6th FDA clearance - EchoGo Amyloidosis! This was an FDA breakthrough designated device and the first device cleared through the FDA TAP program! Here’s why it’s our most important clearance to date: 💙 EchoGo Amyloidosis is the first FDA cleared AI based screening tool, to help detect amyloidosis from an echocardiogram. 💙 Cardiac amyloidosis, is an infiltrative cardiomyopathy in which abnormal proteins form amyloid fibrils that deposit within the heart, causing heart failure. 💙 The two primary subtypes of Cardiac Amyloidosis are transthyretin (ATTR) and immunoglobulin light chains (AL). 💙 Up to two thirds of patients with Cardiac Amyloidosis are missed. 💙 The consequence of the disease is severe, and patients often suffer with increasingly debilitating symptoms and diminishing quality of life. 💙 In ATTR, patients diagnosed with end-stage (stage III) versus early-stage (stage I) disease have a median survival time of 24.1 vs 69.2 months. 💙 In AL, patients diagnosed with end- (stage IV) versus early-stage (stage I) disease have median survival time of 5 vs 55 months. 💙 EchoGo® Amyloidosis demonstrated 85.0% sensitivity and 94.9% specificity in a study, recently presented at the European Society of Cardiology Congress as a Late Breaking Clinical Trial, highlighting its accuracy in detecting cardiac amyloidosis from just a single apical 4 chamber echo video clip. I want to thank our partners Johnson & Johnson Innovative Medicine and Pfizer for their support and making this possible. We look forward to rolling out this technology to enable earlier identification of patients suffering from this disease. https://lnkd.in/emZ4DaJW

199

15 Comments

Time for a sabbatical from a sabbatical. Going out of town for a few weeks and visit family. Will not have access to my sandbox. Packing light and only carrying a few MCU's Using this opportunity to fill up some gaps in my repertoire. For example I rarely document what I do. Hence plan is as follows 1. Start documenting electrical aspects in TinkerCad. I gave it a test ride and its capability is a pleasant surprise. 2. Learn to start documenting code in GitHub. 3. Start using Jupyter Notebook to modularize the sections and hopefully to have it like a tutorial 4. Learn to take decent videos and present. But let us see what I accomplish. The spirit is willing and the tv is inviting. The icing on the cake during this trip is being able to play with Codey the Rocky Mobile Robot which the grand kids have. https://lnkd.in/geXQecsQ

12

1 Comment

If you would like to learn more about reprocessing, listen to the Podcast below with Lars Thording in Healthcare Purchasing News.

1