Bausch + Lomb’s Post

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!

It is not often that one company bats 4 for 4 on Breakthrough Designations! Following our #Breakthrough announcements in #smart #Knees, #Hips and #Shoulders, Canary adds its Smart #Spine program to the roster today! I'm so proud to work with the incredible #engineers and #clinical #regulatory wizards who make news announcements like these look easy; they are in fact impossibly difficult. Today's news is a reaffirming message from the FDA that smart implants, and the data that they produce, are important pieces to the future of #medtech. As big a feat as this achievement is for Canary, Breakthrough is as meaningful for our Smart Spine program. It will not only enhance the regulatory path for this exciting program but Breakthrough Designations also facilitate reimbursement to help important new technologies get to the patients who need them as soon as possible (after cleared by the FDA). Breakthrough Designation qualifies devices for key reimbursement hurdles. Kudos to the FDA for creating a path for ground-breaking new technologies to overcome the hurdles that can often be barriers between patients-in-need and better care. Being first is not always rewarded but in the case of Breakthrough, only the first gets it and the benefits that come with it. Canary is first, again. 😁

Insight into healing - sounds good to me! The lumbar fusion data reporting device from Canary Medical Inc. collects activity levels and kinematics to compare the patient's performance to that of their peers. Hopefully the early insights into spinal fusion progression result in more successful patient outcomes and greater long-term stability. Data to back up the patient's experience can also drive equitable care. I wonder what other kinds of information would be most helpful to guide recovery and return to a healthy lifestyle. Perhaps calculating load experienced on the joint per type of activity and trending that with what kind of load results in the most robust healing and mobility could help inform the type of physical therapies recommended to patients post-op. I would also like to see this implemented with spinal disc replacements, not just spinal fusion devices.

“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. 👏

The Future of Surgical Precision: Exploring the Growth of Automated Suturing Devices Major Players included but not limited to: Medtronic | Smith+Nephew |, Sutrue | Boston Scientific | LSI SOLUTIONS® | B. Braun SE | Johnson & Johnson | Mellon Medical BV | DemeTECH Corporation | Apollo Endosurgery Report Link: https://lnkd.in/dhweHMqR #GlobalAutomatedSuturingDevicesMarket #GlobalMarketEstimates #GME #AutomatedSuturingDevices #HealthcareInnovation #MinimallyInvasive #MedicalTechnology #MarketTrends2029

In this Editorial, we discuss the most recently approved (by the FDA) medical device for below the knee endovascular treatment approaches, in the context of the LIFE-BTK study. Bioresorbable drug-eluting scaffolds hold promise to improve treatment durability of BTK procedures, which may bring much needed benefit to patients suffering from chronic limb-threatening ischemia. https://lnkd.in/d7ravVXz #Mani Kevin

#Operating_Room_Integrated_Systems Market | Latest Trend, Growth & Forecast 2023-2032. >> https://lnkd.in/dtEQtEYr #Healthcare #providers and #regulators prioritize patient safety as a paramount concern. In this context, the integration of multiple #medical #devices and systems through #ORIS becomes crucial, especially in the realm of minimally invasive surgeries where precision and accuracy are of utmost importance. Stryker STERIS KARL STORZ Olympus Corporation Merivaara Corp. Brainlab EIZO IntegriTech Skytron TRUMPF Medical Systems #Operating_Room_Integrated_Systems #medical_device #business_opportunities #marketanalysis #marketresearch #opportunities #business #future 

Unlock the Potential of Precision in Medical Diagnostics: Explore Our Latest Blog on Biopsy Devices. Dive into the comprehensive overview of various biopsy device types, their benefits, maintenance guidelines, and the latest advancements in the field. Highlighting Medorah’s PIVOT® Endoscopic Ultrasound Needle, this cutting-edge biopsy device offers unparalleled precision and reliability in endoscopic procedures. Read the full blog now and share your thoughts! If you're interested in procuring these high-quality, affordable biopsy devices with dedicated procurement support, we are here to assist you. #medzell #medzellb2b #medzellsells #b2bmarketplace #exports #medicaldevicesales #medicaldevices #MedicalSupplies #medzellblog #BiopsyDevices #MedorahMeditek #PIVOTNeedle

💡A recent publication by MacDonald and Rea (2022) sheds light on the nuanced complexities of Carpal Tunnel Release (CTR), a procedure known for its effectiveness yet not devoid of challenges. 📉 With complication rates of 4.1% for Open CTR (OCTR) and 5.0% for Endoscopic CTR (ECTR), the study highlights the critical need for precision and care in surgical approaches. 🔗 https://lnkd.in/eB3RG2u4 🚀 At Spirecut, our patented Sono-Instruments® are at the forefront of this evolution, offering non-invasive, incisionless ultrasound-guided solutions that promise to minimize complications and redefine patient outcomes. Stay tuned as we continue to lead the charge in surgical innovation, making surgeries safer, more precise, and with better recovery times. https://lnkd.in/eJ2xKk3M #Spirecut #InnovationInSurgery #CarpalTunnelRelease #SonoInstruments #MedTech

👏Canary Medical Inc. received breakthrough device designation from the FDA for its smart spine device, Canturio Lumbar Cartridge, designed for lumbar spinal fusion. 🏆 Founding member and CEO Bill Hunter said: “The approval of canturio lc is the fourth time in a row that a Canary Medical product has received breakthrough device designation from the FDA, an unparalleled accomplishment in our industry." 🔗Learn more: https://lnkd.in/dUQUrFTB 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/dwYDkvXQ #MedicalDevices #MedicalDevice #MedicalEquipment #Medicine #HealthTech #Surgeons #GuidedSolutions