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💡 Chris Whitehouse, Chair and Managing Director of Whitehouse Communications reports on the new Regulatory Innovation Office (RIO) in MedTech Innovation News.    The RIO has been introduced by Peter Kyle, Secretary of State for Science, Technology and Innovation to speed up public access to new technologies by removing outdated regulations that hold back development and the take-up of new technologies.    Read all about it here ⬇ New Regulatory Innovation Office delivering new technologies faster - Med-Tech Innovation (med-technews.com) #MedTech #PublicAffairs

🚀 Big Moves in MedTech! 4DMedical Limited (ASX: 4DX) shares surged by 6.2% 📈 at the time of writing, following its exciting new partnership with Queensland-based Qscan Radiology Clinics. 🤝 This deal will see 4DMedical's proprietary pulmonary function and structure products powering advanced respiratory diagnostics. This collaboration not only boosts patient care but also marks a significant milestone for 4DMedical’s growth in the medical imaging sector. 💡 The market has responded enthusiastically, showcasing confidence in the company’s innovative approach. Innovation in action! 🌟  #HealthcareInnovation #MedTech #4DMedical #ASX #Partnership * Click here to subscribe for free 7-day access to our daily market insights and analysis: https://lnkd.in/gzhTXvNT

Less than 24 hours to register and save up to EUR 275 on your #ESCRSiNovation registration. This exciting programme takes place on Friday 6 September 2024 in #Barcelona, Spain – right before the main #ESCRSCongress! Get involved in: 🔬 Unveiling tomorrow's solutions: Witness presentations from 20+ emerging companies showcasing groundbreaking innovations poised to revolutionise the field. 🔬 Witnessing the cutting edge: Be among the first to see pitches from finalists of The Innovators Den, a session highlighting the most promising new technologies in ophthalmic care. 🔬Shaping the landscape: Engage in lively panel discussions with leading experts on critical topics like: Combating #myopia and meeting the needs of tomorrow's patients. 🔬 Networking and collaboration: Connect with a diverse range of stakeholders, fostering valuable partnerships and driving the future of #ophthalmic innovation. Secure your spot before tonight, 26 June 2024, 23:59 CEST to save and take advantage of these incredible initiatives: https://lnkd.in/dUyaQya7 #ESCRSiNovationDay #Ophthalmology #Innovation #FutureofVisionCare #EyeCare

Brisbane-based Convergence Medical has secured AUD 5M in its Series A funding round, attracting global investors to support its innovative medical technologies. #MedTech #Innovation #Funding #Brisbane https://lnkd.in/gqc9s6V7

Weekly MedTech News Summary (Dec 9-13, 2024) 💰 Funding Announcements 💵 ➡Capstan Medical: Raised $110M in a Series C round ahead of its structural heart robot's first-in-human procedure. Maggie Nixon ➡Cala Health: Closed an oversubscribed $50M financing round to support growth in wearable medical technology. Renee Ryan ➡Cleerly: Secured $106M to advance its AI imaging platform for heart disease. James Min, MD ➡Saventic Health: Raised €1.9M to enhance its AI-driven rare disease diagnosis system. Szymon Piatkowski ➡Qnovia, Inc.: Closed $16M in Series B funding for its RespiRx™ Nicotine Inhaler. Brian Quigley ➡NUA SURGICAL: Raised €6.5M to develop its C-section surgical assistance device. Barry Mc Cann 📃#RegulatoryApprovals 📄 ➡Liquet Medical Inc.: Received FDA 510(k) clearance for its Versus catheter. John Schindler ➡FemPulse Corporation: Won FDA IDE approval for its overactive bladder neuromodulation device. Alexandra Haessler, MD ➡SyntheticMR: Gained FDA clearance for its SyMRI 15 imaging solution. Vedran Beglerbegovic ➡Vision RT Ltd RT: Achieved CE Mark certifications for DoseRT, MapRT, and Respiratory Module. Norman Smith ➡Lungpacer Medical: Received FDA premarket approval for its AeroPace neurostimulation system. Doug Evans 🏥 Clinical Trials and Studies 🩺 ➡Protaryx Medical: Completed its first-in-human trial of a transseptal puncture device. David Mester, MBA ➡EndoQuest Robotics™: Secured FDA IDE approval to study its surgical robot for colorectal procedures. Eduardo F. 🚀 Technological Milestones 📢 ➡Positrigo: Completed the first installation of the NeuroLF system in the US. Jannis Fischer The weekly MedTech news summary continues to highlight an unsettling trend: the disproportionate reliance on the FDA for regulatory approvals, while the EU's Medical Device Regulation (MDR) lags significantly behind !!! #MedTech #FDA #MDR #funding GS Capital Connect #HealthcareInnovation Guided Solutions #executivesearch

⚡ Key FDA Clearances and Major Fundings in MedTech this week 💡🏥🚀 🔹 FDA adds RevMedica, Inc. Endo stapling platform to its Safer Technologies Program (STeP). “The STeP designation offers additional validation of the unique advantages of our stapling platform,” said CEO Tom Wenchell 🔹 Led by CEO Sean Saint, Beta Bionics to raise $114.4M in IPO. iLet, an automated insulin delivery system streamlines diabetes management. The company plans to fund the development of the bihormonal configuration of iLet through FDA submissions and develop a patch pump device. 🔹 FDA clears Nalu Medical, Inc. peripheral nerve stim tech for whole-body MRI. It gives physicians greater flexibility in treating chronic pain, minimizing MRI-related limitations with whole-body MRI-conditional use. With this clearance, CEO Thomas A. West is aiming to make peripheral nerve stimulation therapy appropriate for a broader patient population. 🔹 Convergence Medical raises $3.1M for an arthroscopic surgical robot. The Brisbane-based Australian Medtech touts its VO1 robot as the world’s first arthroscopic surgical robot. Led by CEO Dr Chris Jeffery, the company plans to direct funds toward scaling production, expanding global partnerships, and advancing R&D efforts. 🔹 CergenX wins FDA breakthrough nod for neonatal brain monitoring tech. Additionally, the FDA accepted the Cork, Ireland-based company into its Total Product Lifecycle Advisory Program (TAP). Led by CEO Jason Mowles, the company plans to collaborate closely with the FDA throughout its development and premarket review process. 🔹 Led by CEO Jacob Robinson, Motif Neurotech receives a multi-million-dollar grant to develop a brain-computer interface. As a part of the Precision Neurotechnologies program, the U.K.’s Advanced Research and Invention Agency (ARIA) awarded the grant to develop BCI technology to treat cognitive and psychiatric conditions. 🔹 Blackrock Neurotech arrays used in BCI that enable finger-based control using only thought. The human-centered design demonstrated restored finger movement control for the individual with paralysis. #MedTech #Innovation #FDAApproval #MedicalDevices #SurgicalRobot #BrainMonitoring #NeuroTech #HealthcareInnovation #Arevna

It was a pleasure to attend and contribute to the insightful discussions at the Topics in Modern Laboratory Diagnostics conference, organized by Lithuanian Society of Laboratory Medicine🧪, held in Vilnius. The on-line event brought together top professionals of the diagnostics field, sharing knowledge on the latest trends and innovations. A special highlight of the conference was the presentation by Riccardo Melis "How to win Your Pre-analytical challenge: a success case study of the Barcelona Clinical University Hospital"🚀. As Riccardo Melis told, even 62% of diagnostic errors in a clinical laboratory occur due to pre-analytical errors💥. Adopting #ProTube, a modern preanalysis system by #Inpeco, has shown its unquestionable benefits in Barcelona Clinical University Hospital. 👉🏻 The hospital, analyzing more than 5000 various samples in its core laboratory, installed 150 #ProTube units in outpatient sample collection centers, hospital wards and Emergency department. 👉🏻 The benefits are clear: ProTube reduced the total sample turnaround time by 30 minutes, reduced phlebotomist training time and workload, and reduced the rate of pre-analytical errors from 11,38% before installing ProTube to 0,23% after adopting this system. How does #ProTube enable these positive changes in the lab? ✔ Guidance of phlebotomist through sample collection process ✔ Automatic selection of sample tubes, ensuring the right tube is used for each sample ✔ Automatic barcode marking for precise identification and quick access to patient data ✔ Error-free and 100% traceable management of samples, guaranteeing that every step of the process is tracked and accountable The #Protube system is a game-changer in laboratory diagnostics, combining automation with reliability to enhance efficiency, reduce errors, and improve overall workflow in clinical labs. A big thank you to #Inpeco, a valuable partner of #Multilab, #Interlux Group company and Riccardo Melis for engaging presentation and for showcasing such an impactful technology in the field of laboratory diagnostics. We’re excited to see how #ProTube will continue to transform sample management in Lithuanian labs! Looking forward to the continued growth and collaboration in this rapidly advancing field! #LaboratoryDiagnostics #Inpeco #Protube #Multilab #Interlux #BloodSampleAutomation #HealthcareTechnology #Diagnostics #MedicalDevices

"The future of medical technology requires a clear political vision". Clara Hellner, former head of the board for MedTechLabs writes in industry paper Medtech Magazine on how collaboration between medical and technical skills can lead to groundbreaking innovations and why clarity of political vision is needed to strengthen Sweden's position as a leader in medical technology. Unlocked article (in Swedish). #medtechinnovation #regionstockholm https://lnkd.in/df76BVWh

Discover the highlights of #CSIAmerica25! Register here: https://lnkd.in/gt8sXGYk 🌡️ Hot and new topics This interdisciplinary session delves into the latest advancements in cardiovascular care, including innovations in imaging, #bioresorbabledevices, stent technologies, and cutting-edge interventional tools. 💡 Physician-led medical device innovation (How to turn your idea into a start-up) Moderated by Horst Sievert and Shakeel Qureshi, this session, featuring expert panelists, will provide a step-by-step guide on transforming a medical device idea into a #startup. Topics include market analysis, patenting, prototyping, testing, and securing funding. 🤔 "What would you do?" sessions These interactive discussions allow participants to work through clinical cases step-by-step with speakers and panelists. Engage in real-time decision-making and build practical skills that translate directly to your practice. 🌎 Latin America session Latin American physicians will present complex and unique cases, highlighting regional practices and innovative solutions. This session allows attendees to gain new perspectives and insights from diverse clinical experiences. 📞 Time to phone a friend (PICES@CSI) Collaboration is key in challenging situations. Learn how mentorship and input from specialists in other disciplines can enhance success in complex cases. #CSIAmerica2025 #cardiology #cardiologyconference #csifamily

Diagnexia Responds to Growing Client Demand with Strategic Expansion at Exeter Science Park. Responding to increasing demand, Diagnexia has strategically relocated to a larger facility equipped with advanced digital pathology technology. This move significantly boosts our capacity and capabilities, ensuring we can deliver even faster and more precise diagnostics to support our NHS partners and other healthcare clients. 🔹 Enhanced capacity to manage increased client volume 🔹 State-of-the-art digital scanners for superior diagnostic accuracy 🔹 Strengthened commitment to improving patient care outcomes Dr. Donal O'Shea, CEO of Deciphex, stated, "Our move marks a significant step in our journey towards transforming digital pathology. With this larger space, we're not just expanding our physical footprint but also our capacity to innovate and efficiently meet the growing demands of our clients." 🔗 https://lnkd.in/ehHSBaa8 #Diagnexia #ExeterSciencePark #DigitalPathology #HealthTech #NHS