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Top o' the Mornin' to Ya! 🍀 As we jump into another big week in #medtech, let's first run through a few highlights from last... MedTech Innovator kicked off their 2024 Pitch Event Road Tour in LA, an incredible opportunity for the #innovators and #entrepreneurs in our industry to pitch and potentially partner with the largest nonprofit accelerator in the world. Congratulations to all those that will move forward! Paul Grand Busy week for #surgicalrobotics as Intuitive won #FDA clearance for its next gen Davinci 5, their most advanced and integrated system yet, while SS Innovations announced its first #mitral valve replacement using their robot. CMR Surgical announced a first use case of their platform in #Sweden Supratim Bose Mark Slack Luke Hares Cosm Medical received clearance for its #pelvicfloor technology, making the first personalized pessary available Derek Sham #Diabetes was active this week as the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) was held in Italy, Medtronic Diabetes, Dexcom, and Abbott all announcing positive progress. Centese made big strides in their their clinical trials for better #cardiacsurgery and #atrialfibrillation care Evan Luxon Randy Preston, while Abbott and Edwards Lifesciences continue their race in better #tavr technologies Autonomix Medical completed its first #RF #ablation trial to treat #pancreatic cancer pain, important mission Lori Bisson and team More buzz with #neuro as SetPoint Medical won an approval for the treatment of #MS, and Axonics, Inc. received a new #CEMark, and Sooma Medical raised $5.4 Mil for their depression #neuromodulation device Tuomas Neuvonen SafeGuard Surgical won a FDA Breakthrough nod for a #colorectal stent developed in #Tampa Fl Scott Kelley, MD Affluent Medical announced #FIH implant of their #urinaryincontinence device Sebastien Ladet, Ph.D. Finally, my favorite article of the week is interesting as the Total Product Lifecycle Advisory Program (TAP) within #FDA is new, and in particular helpful for innovation like #BCI technology and ONWARD Medical. This program requires Breakthrough Device Designation, and is assembled to provide earlier and more frequent engagement with company and agency, ideally streamlining the process. THANK YOU to all my newspartners LSI, MassDevice, MedTech Dive, FierceHealthcare, Sean Whooley, Tom Salemi, Chris Newmarker, Danielle Kirsh and friends everywhere who share stories. https://lnkd.in/e9WSbrYJ

Weekly #MedTech news summary 12th of July 2024 Q3 is already bringing some exciting developments in the #medtech industry. Here are some of the most notable headlines from the past week, as shared by Guided Solutions. New4med GmbH launched its basivertebral nerve ablation therapy in #Europe, with CEO Daniel Seifert hoping it will help more people with vertebrogenic pain. Medical Microinstruments, Inc. and Mark Toland signed new #distribution agreements in Europe and Japan for its Symani #surgical robot system. Carthera won funding from the #French government’s Forfait Innovation programme for a #clinical trial of its blood-brain barrier opening implant SonoCloud-9 - CEO Frédéric Sottilini expressed optimism about their next steps. SmartCella Holding AB also raised a significant $54m through a share issue to support the commercialisation of its #endovascular device, the Extroducer. Wishing CEO Niklas Prager and the team all the best. Funding was secured by Adona Medical too, who raised $33.5 million in Series C #financing led by Cormorant Asset Management, LP and TCP Health Ventures to support its adjustable heart shunt technology – great job to CEO Brian Fahey and the team! $10million was secured by Endoron Medical in Series A led by Sofinnova Partners and significant contribution from European Innovation Council and SMEs Executive Agency (EISMEA) to advance its flagship EndoStapling solution Aortoseal (designed to help repair abdominal aortic aneurysms) through clinical studies. In clinical trials, Genetesis, led by CEO Peeyush Shrivastava, enroled the first patient in its MICRO2 trial for magnetocardiography for CMD patients. Vectorious Medical Technologies shared positive clinical data for the V-LAP miniature digital pressure sensor device which measures left atrial pressure. Co-founder and CEO Eyal Orion, MD expressed excitement for the system’s potential. CSA Medical Inc completed enrolment in a pivotal trial for RejuvenAir - a cryospray, designed to induce a regenerative effect on endobronchial tissue. Wishing the best of luck to CEO Wendelin Maners and the team. In #regulatory #news - Pulse Biosciences, Inc. won #FDA #breakthrough #device designation for its Cardiac Surgery System for ablating cardiac tissue. Congratulations to CEO Burke T. Barrett. Another notable FDA clearance was granted to Orthofix for its Fitbone Transport and Lengthening System. The company also completed the first implant of the device. Congratulations to CEO Massimo Calafiore. And as I was putting this together CEO Sebastien Ladet, Ph.D. announced that Affluent Medical has signed several agreements with Edwards Lifesciences related to their mitral product and technology. Well done to the whole team. #fundraising #innovation #clinicaltrials #executivesearch

US MEDICAL DEVICE MANUFACTURING WEEKLY ROUND-UP 😷 👨⚕️ Richard Wolf Medical Instruments Corporation and Photocure have entered a partnership to develop a 4K LED high-definition reusable flexible blue light cystoscope. The collaboration aims to bring BLC equipment to the US market, strengthening treatment for bladder cancer. 💊 Edwards Lifesciences announced its plan to acquired Innovalve Bio Medical Ltd. The deal will add to Edward's transcatheter aortic valve replacement Business, which remains the companies largest unit after sales climbed to $73M in the first quater. 🏥 Synchron announced the integration of generative AI into its brain implant interface system. The system will allow people living with non-verbal disabilities such as amyotrophic lateral sclerosis, to generate text to screen faster than ever! 💉 Quest Diagnostics to buy LifeLabs Medical Laboratory Services. The $985M deal is expected to generate $710M in sales annually. #Medicaldevices #medicaldevicemanufacturing #usmedicaldevice #usmedicaldevicemanufacturing

#NeurovascularSurgery: Emerging Tech Innovations in Devices - A Boon for the Global #MedicalDiagnostics Industry Download PDF Brochure for More Insights: https://lnkd.in/dUkRxhWK Major Growth Drivers: The rise in the prevalence of various neurovascular diseases, the growing popularity of minimally invasive surgical procedures, the development of the healthcare infrastructure in developing nations, and the strategic alliances and collaborations between research institutions and manufacturers to advance new advancements in interventional neurology are all factors contributing to the market's growth. The acceptance of neurovascular treatment is hampered, nevertheless, by the high cost of neurovascular interventional procedures and associated devices, particularly in developing nations with lax reimbursement rules. Projected Surge in Global Revenue: According to revenue estimates, the global market for neurovascular devices was valued at $3.6 billion in 2023 and is expected to rise at a compound annual growth rate (CAGR) of 8.7% to reach $5.5 billion by 2028. Stryker Johnson & Johnson Medtronic Terumo Medical Corporation Penumbra, Inc. Abbott Siemens Healthineers Boston Scientific MicroPort NeuroTech Integra LifeSciences Merit Medical Systems, Inc. Cordis Balt Edwards Lifesciences Philips LeMaitre CARDIONOVUM GmbH ev3 Aesculap (US) AGA Medical Blaze Medical Devices, Inc.

NUERALINK'S FIRST-IN-HUMAN CLINICAL TRIAL IS OPEN FOR RECRUITMENT The PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface) – a groundbreaking investigational medical device trial for our fully-implantable, wireless brain-computer interface (BCI) – aims to evaluate the safety of our implant (N1) and surgical robot (R1) and assess the initial functionality of our BCI for enabling people with paralysis to control external devices with their thoughts. During the study, the R1 Robot will be used to surgically place the N1 Implant’s ultra-fine and flexible threads in a region of the brain that controls movement intention. Once in place, the N1 Implant is cosmetically invisible and is intended to record and transmit brain signals wirelessly to an app that decodes movement intention. The initial goal of our BCI is to grant people the ability to control a computer cursor or keyboard using their thoughts alone. The PRIME Study is being conducted under the investigational device exemption (IDE) awarded by the FDA in May 2023 and represents an important step in our mission to create a generalized brain interface to restore autonomy to those with unmet medical needs. Those who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify.    Read more at: https://lnkd.in/dAD4eJSq #Neuralink #BCI #clinicaltrialALS #PRIME

Here’s the List of top 5 Medical Device Startups to watch in 2024 (Final Part) 1. Enable Injections, Inc. Based in Ohio, Enable Injections is revolutionizing drug delivery with their enFuse on-body disc. This innovative device discreetly administers medication through a concealed, lightweight disc attached to the skin. Featuring a small, unseen needle for drug delivery, it offers comfort and flexibility, catering to those with needle phobias. Securing patents in 2022 and backed by over $215 million in financing, Enable Injections is poised to leave an indelible mark in the medical device landscape. 2. hemotune AG Hemotune, a Swiss med-tech firm, pioneers magnetic blood purification. Their technology uses magnetic beads to extract pathogens, toxins, antibodies, and cytokines from the bloodstream via a dialysis-like process. Promising a three-part 'hemosystem,' Hemotune aims to transform blood treatment for septic shock, infections, and autoimmune diseases. 3. SimBioSys, Inc. SimBioSys, pioneers an SaMD platform for 'computational oncology.' Their technology digitally models cancer behavior, offering precise, pre-simulated cancer care by analyzing tumor growth and medication impact. With various regulatory targets in sight, including 510(k) clearance, MDSAP, ISO 13485, and IEC 62304 accreditation, their upgraded eQMS in 2022 paved the way for a rapid, market-ready quality system within 90 days, setting the stage for significant market success this year. 4. Shockwave Medical Shockwave Medical repurposes sound wave technology from kidney stones to tackle calcified artery blockages. Their FDA-approved intravascular lithotripsy (IVL) device offers a safer alternative to traditional methods like balloons and drills for breaking down artery plaque. Now in its second year on the market, Shockwave is a standout among medical tech companies to watch this year. 5. Synchron Brooklyn's Synchron achieves FDA IDE approval for its stentrode, a groundbreaking brain computer interface. This implantable device marks a milestone in brain technology. Conducting clinical trials aiming to map the brain's intricate blood vessel network, Synchron aims to revolutionize brain communication with digital advancements. #aiinhealthcare #dubaihealthcare #medicaldevicemanufacturing

Laborie Medical Technologies has completed its acquisition of Urotronic, the #medicaldevice company, as previously announced. According to TechSci Research, the acquisition of Urotronic by Laborie Medical Technologies is expected to be advantageous for both companies. Urotronic's innovative #medical technologies, including the Optilume drug-coated balloon #technology, complement Laborie's existing diagnostic and therapeutic solutions. This strategic diversification allows both companies to expand their product and service offerings, enhancing their competitiveness and market presence. Additionally, the acquisition is likely to lead to increased investments in research and development, which will support the creation of advanced medical devices and therapies.

Grab your morning ☕️ as you read through our Thursday #MedTechNews roundup! Abbott's Heartmate device, acquired in 2017, is crucial for end-stage heart failure patients, often serving as a bridge to transplantation. With Medtronic's exit from the market, Abbott's Heartmate 3 LVAD is the FDA-endorsed alternative. Despite its life-saving potential, the device carries risks, including death and stroke. Abbott recently recalled version 1.0.32 of the Heartmate Touch communication system due to software issues that could affect device control during procedures or monitoring, impacting 1,560 devices distributed in the U.S. from May 7, 2020, to Dec. 18, 2023. https://lnkd.in/gS9HGFns Medtronic has merged its patient monitoring and respiratory intervention divisions into a new multibillion-dollar arm called acute care and monitoring, reversing previous plans for spinoff or sale. This shift underscores the company's renewed focus on data-driven healthcare solutions. Exiting the hospital ventilator business due to declining profitability post-COVID-19, Medtronic is doubling down on category leadership and investing in R&D to tackle critical clinical challenges. Frank Chan, head of ACM, emphasises: "We've never stopped competing, managing, or discussing synergies. We're enthusiastic about our future." https://lnkd.in/gBqEEhTN Moody's’s, renowned for its credit ratings and risk analysis, has released a report delving into the potential impact of artificial intelligence (AI) on the credit quality of companies within the medical device, pharmaceutical, and healthcare services sectors up to 2030. The report highlights AI's potential to enhance product offerings and efficiency and underscores benefits for larger firms with robust resources and proprietary data. However, it warns of risks such as data quality issues and cybersecurity threats, alongside uncertainties surrounding evolving regulations, which could temper AI's full benefits for credit quality. https://lnkd.in/gvG5u5sv Solventum, a newly independent company with 22,000 employees across four divisions, achieved $8.2 billion in sales and $1.35 billion in nett income in 2023. 3M will distribute 80% of Solventum's stock to shareholders, retaining the remainder, with plans to divest its stake within five years. Forecasts suggest a 4% to 6% annual growth in Solventum's market, driven by expanding health information systems valued at $9 billion, expected to grow at 6% to 8% annually. https://lnkd.in/gFV7yTxe Stay connected for the latest in #Medtech news! Follow TRESP Recruitment - Medtech and Healthtech Experts to stay in the loop and never miss an update. #MedTechNews #MedicalDevices #HealthcareInnovation #MedTechIndustry #MedDeviceNews

In #cardiology, there is a great deal of promise around using #pulsedfieldablation to treat #AFib. Experts from #MedtechBig100 device developers — including Medtronic, Johnson & Johnson MedTech's Biosense Webster, Abbott and Boston Scientific — discuss the various shapes of their pulsed field ablation (PFA) catheters. Check it out below. #medtech #meddevice

The Electrophysiology market is booming, and two technologies are set to make a significant impact on patients and reshape the market landscape. PFA and LAA are the trends to watch in AFib ablation and clot prevention. By 2028, the AFib ablation market is expected to double, with PFA procedures accounting for over 60% of total cases. Medtronic and Boston Scientific are leading the way in PFA innovation, presenting a safer and more precise treatment option for patients. In LAA treatment, Abbott entered the market in 2021, and Medtronic and J&J announced acquisitions to break into the category last year. The LAA treatment space is projected to grow 20% this year and quadruple to $6b by 2030. BSC is the incumbent market leader, but differentiated innovation presents another opportunity for disruption of existing market dynamics. Exciting times are ahead for the Electrophysiology market as these two critical trends continue to evolve. Stay tuned for more updates on this rapidly evolving space. https://lnkd.in/dxzuGfz5 #Electrophysiology #MedTech #PFA #LAA #AFib #Innovation #MarketTrends #PatientOutcomes