Guided Solutions

We're turning 25! 🎉 This year marks a major milestone for Guided Solutions - 25 years of connecting visionary companies with the leaders who drive them forward. To mark the milestone, we asked our team to share what motivates them - as individuals, and as part of Guided Solutions. It’s a glimpse into the values that have shaped our journey: purpose, partnership, and a deep belief in doing things differently. Thank you to our clients, candidates, and colleagues who’ve shared this path with us. Here’s to building what’s next! If you're growing your team - or exploring your next chapter, let’s talk: 👉 https://bit.ly/4isKIPy #25YearsGuidedSolutions #ExecutiveSearch #MedTech #MedTechCareers #HiringWithPurpose #LifeAtGS

💸 MedTech Industry News – Week 22, 2025 💰 Funding Announcements Salvia BioElectronics raised $60M Series B to scale its minimally invasive neuromodulation therapy for chronic migraine Surgify Medical Oy closed €7M to expand its soft-tissue-preserving Halo bone surgery platform Brainreader raised €6.6M for its AI-based Neuroreader MRI analysis software. PorTal Access, Inc. raised $7M for its next-gen chemotherapy port for women’s health See All AI raised $33M to bring real-time 3D surgical imaging to the OR using only two fluoroscopy inputs hormona secured $6.7M to develop the world’s first end-to-end hormonal health platform STIL raised over €2M to bring its tremor-stabilising wearable to more patients Accelus received growth funding to advance its spinal implant innovation pipeline Carlsmed raised $52.5M Series C to drive adoption of its personalised spine surgery system Quasar Medical | Medical Device Manufacturer acquired Nordson Medical’s CDMO operations in Ireland and Mexico Quadria Capital closed a $1.07B fund focused on healthcare in emerging Asia Cathay Innovation launched a €1B AI fund targeting sectors including MedTech Picus Capital reached a €250M hard cap on its early-stage investment fund 🛃 Regulatory Approvals AnX Robotica Corp: FDA 510k for its MotiliCap capsule and MotiliScan software for GI motility tracking Reflow Medical: De Novo for Spur, the first retrievable #stent for infrapopliteal disease Abbott: FDA approval for Tendyne, enabling #mitralvalve replacement without open-heart surgery Medtronic: STEP designation for next-gen pulse oximetry improving accuracy across skin tones Olympus Corporation: FDA cleared its most advanced GI #endoscope platform to date Empatica: CE Mark for its #wearable seizure monitoring system Distalmotion: FDA 510(k) for Dexter in cholecystectomy, expanding robotic access to outpatient settings LEM Surgical AG: FDA 510(k) for Dynamis, the first spine-specific robotic #surgery platform CoreMap: FDA IDE for CORE Dx, a novel system for atrial tissue mapping in ablation planning AI Medical Technology: CE Mark for Dermalyser, an AI-powered smartphone tool for #melanoma detection CoapTech: FDA for PUMA-G Pediatric, the first ultrasound-based #gastrostomy tube placement for children 🧪 Clinical Milestones NeuroPace: One-year trial data show safety and efficacy of #neuromodulation for generalised epilepsy RevBio, Inc.: UK MHRA approval for clinical trial of TETRANITE, a regenerative adhesive for cranial fixation GreenBone Ortho Pre-market study shows 100% spinal fusion using b.Spine in thoracolumbar disease Sensome: Completed enrollment for INSPECT study—evaluating intraoperative tumor sensing during lung biopsy BetaGlue Therapeutics: ASCO abstract highlights promising safety and tumour necrosis using YntraDose in pancreatic cancer 📩 If you're building in #MedTech — we’re watching. DM us to share your update or milestone. 👇 For the full breakdown, check the Substack link in the comments.

We're #hiring a new Clinical Manager EMEA – Wound Care in EMEA. Apply today or share this post with your network.

Two weeks until LSI Asia '25 in Singapore! I’ll be joining the summit on behalf of @GS Capital Connect and @Guided Solutions, and I’m looking forward to conversations that bridge innovation, investment, and impact across Asia’s healthcare landscape. What excites me most about these events is witnessing that moment when groundbreaking healthcare technology meets the right investment partner, and the right talent to scale it. Whether you're building something revolutionary in MedTech, looking to invest in healthcare's future, or need the right talent to accelerate your growth, get in touch! #LSIAsia25 #MedTech #Healthcare #Singapore #ExecutiveSearch #Fundraising

Catch up on the latest funding deals in MedTech with GS MedTech Funding Tracker - our weekly summary of key financing in MedTech from the week. In this edition 👇 📌Neuralink 📌Salvia BioElectronics 📌EBR Systems, Inc. 📌Acclaro Medical 📌Surgify Medical Oy 📌PorTal Access, Inc. 📌Brainreader 📌STIL 👉 Read the full stories: https://lnkd.in/df4Mwhpy 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/eGyRtMwE #MedicalDevices #MedicalEquipment #HealthTech

We're #hiring a new Medical Advisor - Spine in United Kingdom. Apply today or share this post with your network.

Reflow Medical received FDA De Novo clearance for its Spur Peripheral Retrievable Stent System, the first retrievable stent designed to treat infrapopliteal arterial disease using self-expanding spikes for lesion modification and vessel compliance improvement. Clinical trial results showed a 99.2% technical success rate. 📣 Reflow Medical CEO and Co-Founder, Isa Rizk, “The FDA’s De Novo clearance, following positive clinical trial results in patients with CLTI, enables us to provide physicians with an effective therapeutic option for this growing patient population." 👉 Full story: https://lnkd.in/d-4mHVDQ 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/dt8EPj4Z #MedicalDevices #MedicalEquipment #HealthTech #MedTechNews

🚨 FDA Breakthrough ≠ Automatic Reimbursement 🚨 After I shared the list of 32 FDA Breakthrough Devices cleared in 2024, Mark Copeland raised a valid question: 👉 𝗗𝗼𝗲𝘀 𝗙𝗗𝗔 𝗕𝗿𝗲𝗮𝗸𝘁𝗵𝗿𝗼𝘂𝗴𝗵 𝘀𝘁𝗮𝘁𝘂𝘀 𝗺𝗲𝗮𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗿𝗲 𝘄𝗶𝗹𝗹 𝗰𝗼𝘃𝗲𝗿 𝘁𝗵𝗲 𝗱𝗲𝘃𝗶𝗰𝗲 — 𝗮𝗻𝗱 𝗮𝘁 𝗯𝗲𝘁𝘁𝗲𝗿 𝗿𝗮𝘁𝗲𝘀? It’s a great question, and after initial research the answer is: 𝗻𝗼𝘁 𝗮𝘂𝘁𝗼𝗺𝗮𝘁𝗶𝗰𝗮𝗹𝗹𝘆. ✅ The 𝗙𝗗𝗔 𝗕𝗿𝗲𝗮𝗸𝘁𝗵𝗿𝗼𝘂𝗴𝗵 𝗗𝗲𝘃𝗶𝗰𝗲 𝗣𝗿𝗼𝗴𝗿𝗮𝗺 helps speed up regulatory review for technologies that address serious, unmet medical needs. But reimbursement is a separate decision. To bridge the gap, CMS (Centers for Medicare & Medicaid Services) has introduced:  🆕 𝗧𝗖𝗘𝗧 – 𝗧𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻𝗮𝗹 𝗖𝗼𝘃𝗲𝗿𝗮𝗴𝗲 𝗳𝗼𝗿 𝗘𝗺𝗲𝗿𝗴𝗶𝗻𝗴 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝗶𝗲𝘀 🔍 What TCET does: 𝗢𝗳𝗳𝗲𝗿𝘀 𝗮 𝗳𝗮𝘀𝘁𝗲𝗿 𝗮𝗻𝗱 𝗺𝗼𝗿𝗲 𝗽𝗿𝗲𝗱𝗶𝗰𝘁𝗮𝗯𝗹𝗲 𝗽𝗮𝘁𝗵 𝘁𝗼 𝗠𝗲𝗱𝗶𝗰𝗮𝗿𝗲 𝗰𝗼𝘃𝗲𝗿𝗮𝗴𝗲 𝗔𝗰𝗰𝗲𝗽𝘁𝘀 𝘂𝗽 𝘁𝗼 𝟱 𝗙𝗗𝗔 𝗕𝗿𝗲𝗮𝗸𝘁𝗵𝗿𝗼𝘂𝗴𝗵 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 𝗽𝗲𝗿 𝘆𝗲𝗮𝗿 𝗘𝗻𝗮𝗯𝗹𝗲𝘀 𝘁𝗲𝗺𝗽𝗼𝗿𝗮𝗿𝘆 𝗿𝗲𝗶𝗺𝗯𝘂𝗿𝘀𝗲𝗺𝗲𝗻𝘁 (𝗼𝗳𝘁𝗲𝗻 ~𝟱 𝘆𝗲𝗮𝗿𝘀) 𝘄𝗵𝗶𝗹𝗲 𝗺𝗼𝗿𝗲 𝗲𝘃𝗶𝗱𝗲𝗻𝗰𝗲 𝗶𝘀 𝗰𝗼𝗹𝗹𝗲𝗰𝘁𝗲𝗱 𝗦𝘂𝗽𝗽𝗼𝗿𝘁𝘀 𝗳𝗶𝘁-𝗳𝗼𝗿-𝗽𝘂𝗿𝗽𝗼𝘀𝗲 𝘀𝘁𝘂𝗱𝗶𝗲𝘀 𝗮𝗻𝗱 𝗿𝗲𝗮𝗹-𝘄𝗼𝗿𝗹𝗱 𝗱𝗮𝘁𝗮 ⚠️ But TCET is voluntary and highly selective — most devices still go through traditional coverage processes. And even for TCET candidates, reimbursement depends on demonstrating benefit for the Medicare population. So while the 32 breakthrough devices represent amazing innovation — from AI-driven diagnostics to new cardiac interventions — they are not all reimbursed yet, and only a few will qualify for TCET support in 2025. 📌 𝗦𝘂𝗺𝗺𝗮𝗿𝘆:  𝗙𝗗𝗔 𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹 𝗶𝘀 𝗼𝗻𝗲 𝗺𝗶𝗹𝗲𝘀𝘁𝗼𝗻𝗲.  𝗖𝗠𝗦 𝗰𝗼𝘃𝗲𝗿𝗮𝗴𝗲 𝗶𝘀 𝗮𝗻𝗼𝘁𝗵𝗲𝗿 — 𝗮𝗻𝗱 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝘀 𝗮 𝘀𝗲𝗽𝗮𝗿𝗮𝘁𝗲 𝗲𝘃𝗶𝗱𝗲𝗻𝗰𝗲 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝘆. 📥 Want the full breakdown of which devices made the 2024 list, what they do, and how they reflect market trends?  👉 Link in the comments. #MedTech #FDA #CMS #BreakthroughDevices #TCET #HealthcareInnovation #MedicalDevices #Reimbursement #HealthPolicy #DigitalHealth #GSConnects #VentureCapital

Heading to LSI Asia '25 in Singapore in just two weeks! I’ll be attending on behalf of both GS Capital Connect and Guided Solutions, as we turn our attention to new horizons and explore the vibrant opportunities emerging across the Asian MedTech landscape. Singapore is the ideal gateway to the region — a hub of innovation, investment, and bold ambition. We are excited to meet the founders building the next generation of health technologies, the investors fuelling their growth, and the leaders shaping the future of MedTech globally. If you are investing, raising capital, building your team, or simply want to exchange ideas — let’s connect. Kelly Williams Blake Matrone LSI #LSIAsia25 #MedTech #ExecutiveSearch #Fundraising #Singapore #Healthcare #AsiaExpansion #NewHorizons

🚀 The latest edition of the GS MedTech Chronicle is out! We’re spotlighting the companies reshaping orthopaedic repair - from bioresorbable implants to plant-inspired scaffolds that mimic real bone. Meet the innovators pushing boundaries, the science fueling progress, and what it all means for the future of skeletal healing. #MedTech #Orthopaedics #BoneHealing #HealthcareInnovation #GSMedTechChronicle