Medtech Leaders

🎊 As we take a chance to reflect on what was a fantastic LSX USA Congress at the beginning of September, and look ahead to LSX Nordic Congress next week (there's still time to grab your tickets!). We wanted to highlight some of the recent successes we have seen from our incredible alumni. 🧠 Kurt Haggstrom and the Synchron team announced positive results from the year long US COMMAND study of its BCI device https://t.ly/ChI8z 💰 Marissa Fayer and DeepLook Medical announced the close of its Series A funding round alongside the release of new data highlighting the impact of the DL Precise™ product https://t.ly/VtJ4z 🧠 Carolina Aguilar and the INBRAIN Neuroelectronics team saw the successful first in human usage of its graphene based BCI, paving the way for an initial study of up to 10 patients https://t.ly/up0Ul Secure your place at LSX Nordic Congress, October 8-9th: https://lnkd.in/e37TMufY

⏰ It's now less than 2 weeks until LSX USA Congress!! Here's a medtech round-up to tide you over until you join us at the Hynes Convention Center on the 11th and 12th of September ✅ Illumina received FDA approval for cancer tissue profiling test along with two companion diagnostics https://t.ly/FSpwM ✅ Boston Scientific obtained CE mark for the ACURATE Prime™ Aortic Valve System, ahead of schedule https://t.ly/1qp2a ✅ Insulet Corporation received FDA approval for first automated insulin pump for type 2 diabetes, Omnipod 5 https://t.ly/nRj53 💸 Getinge and organ preservation company Paragonix Technologies, Inc. sign definitive acquisition agreement worth $477M as Getinge enters the transplant market https://t.ly/tcKHQ 🆕 Dexcom launched its first over-the-counter continuous glucose monitor for those not using Insulin https://t.ly/NwsVu #medtech #mergersandacquisitions #fda #CEmark #medtechcompliance #diabetes #TAVR #precisiondiagnostics #cancer

⏫ Things are ramping up here at LSX - partnering for Life Science eXecutives ahead of our US events in September LSX USA Congress and RNA Leaders USA, but we've still had our eyes on the latest medtech news: 💸 Johnson & Johnson MedTech announced an agreement to acquire V-Wave in a deal worth up to $1.7B, with $600M up front https://t.ly/Rn2Ok ✅ NOWDiagnostics | NOWDx received FDA approval for its First To Know, at home syphilis test. The first of its kind https://t.ly/YcxeF ➕ Neptune Medical announced the launch of Jupiter Endovascular off the back of a $97M Series D funding round https://t.ly/TBEXe ✅ PROCEPT BioRobotics received FDA approval for its robotic prostate surgery system HYDROS™ https://t.ly/WiKQz 💸 ZOLL Medical Corporation announced an agreement to acquire Vyaire Medical ventilator business following a $37M offer in virtual auction of company's assets https://t.ly/0YyL 💸 Edwards Lifesciences announced its acquisition of JC Medical, Inc., including the IP and commercial rights of the J-Valve® TAVR system, from Genesis Medtech Group in a deal worth $25M https://t.ly/B39NN

🔥 It's been another busy week in the wonderful world of medtech. Here's your Friday Medtech Roundup. 💸 Zimmer Biomet announced a definitive agreement to acquire OrthoGrid Systems, Inc. https://t.ly/_IZlb 💸 Stryker announced a definitive agreement to acquire care.ai https://t.ly/UkHnB 💰 HistoSonics, Inc. closed an immensely impressive $102M Series D round https://t.ly/Nzu0f 💰 CroiValve completed a $16M Series B round https://t.ly/ZqLzq ✅ Cresilon received FDA clearance for its TRAUMAGEL® hemostatic gel technology https://t.ly/bUoO4

⏰ It's Friday so it must be time for another Medtech Round up! 🧠 Exciting times for INBRAIN Neuroelectronics and CEO Carolina Aguilar as they prepare for the first in human trial of its graphene brain implant https://t.ly/XS0wN 🤝 Abbott and Medtronic announce a landmark partnership to change diabetes monitoring. The two medtech giants will aim to combine Abbott's continuous glucose monitor with Medtronic's insulin delivery devices https://t.ly/Z1wHd ✅ Diality has received FDA approval for its smart Moda-flx Hemodialysis System™ https://t.ly/40O09 ✅ DePuy Synthes has received 501k approval for its VELYS™ robotic-assisted surgery solution https://t.ly/hNzYA ✅ Inspire Medical Systems announced FDA approval for its minimally-invasive obstructive sleep apnoea solution, Inspire V https://t.ly/iYYxU 🎤 Hear from Carolina Aguilar - INBRAIN Neuroelectronics on our Successful Payer Relationships Panel this September at the LSX USA Congress, alongside Georgia Mitsi, Christian Howell, Willem Baralt and Chris Springate

☀ As we come to the end of another sweltering week here in London, it's time to look back at the hottest news in Medtech ✅ Guardant Health received FDA approval for its Shield™ blood test, paving the way for a new era of colorectal cancer screening https://t.ly/XWwqC 📈 Boston Scientific saw YoY sales of cardiovascular devices increase 20%, powered by 125% growth in revenues of its electrophysiology devices for atrial fibrilation https://t.ly/3zx6i ⏳ GE HealthCare became the most recent tier 1 medtech company to discuss delays in the China market, following a slower than anticipated rollout of a central government financial stimulus program, in its earnings report. This follows Johnson & Johnson and Philips citing the issue https://t.ly/r8j1K 📰 The FDA have started the recruitment process as they look for a new director of the CDRH, following news that Jeff Shuren will be retiring https://t.ly/tfKcu

📈 As companies worldwide are announcing their H1 Financial Reports, we felt it a great time to review some of the recent financing news in the Medtech space 💰 Element Biosciences have announced $277M in series D investment in its bid to put a dent in Illumina's market share https://t.ly/k_BAs 💸 Edwards Lifesciences have exercised its option to acquire Innovalve Bio Medical Ltd. after originally investing in the start-up back in 2017, in a deal worth $300M https://t.ly/qjrFb 💸 Lantheus have announced its acquisition of Meilleur technologies following the Centers for Medicare & Medicaid Services proposing a separate payment pathway for some nuclear imaging agents and diagnostic radiopharmaceuticals https://t.ly/dS1dZ 💸 Edwards Lifesciences also announced its acquisition of both JenaValve Technology, Inc. and Endotronix in deals worth a combined $1.2B plus an additional $445M should future milestones be hit https://t.ly/9Mdva 💸 GE HealthCare have reached a deal to acquire AI assets from Intelligent Ultrasound in a deal worth around $51M https://t.ly/-vJiz

⚽ Ahead of a big weekend for English football fans, it's your Weekly Medtech round-up! 💸 Quest Diagnostics have announced a deal to acquire LifeLabs Medical Laboratory Services from OMERS in a deal worth approximately $985M https://t.ly/NGTLS 📰 The Wall Street Journal are reporting that Baxter International Inc. are considering the sale of its kidney care unit Vantive, to private equity firm The Carlyle Group in a deal worth over $4B https://t.ly/wxkpI ✅ Roche received CE marking for its continuous glucose monitor this week, paving the way for the solution to launch in select European markets in the coming months. Will this approval disrupt the majority role Abbott and Dexcom play in the CGM market? https://t.ly/xliCb ⚠ Pulse Biosciences, Inc. has announced its plan to pursue pre-market approval for its CellFX cardiac clamp technology, delaying a program which was previously on the 501(k) pathway. This shift has caused experts to suggest the device will now not reach market before late 2026 https://t.ly/Dndy1

🎆 Happy 4th of July weekend to our American friends, it's time for another Friday Medtech round up! 💸 BELKIN Vision, and their automated laser therapy for glaucoma, have been acquired by Alcon in a deal which could be worth up to $466M including sales-based milestone payments https://t.ly/LIxTP ⚖ Roche have filed a lawsuit against Foresight Diagnostics accusing the diagnostics company of being built on trade secrets https://t.ly/Pok1Z 💼 Dexcom are cutting 535 jobs as they move their manufacturing operations to Arizona https://t.ly/leOl8 💥 Masimo's proxy fight has led to over 280 leaders and engineers, including COO Bilal Muhsin (https://t.ly/ysfqf), threatening to walk should CEO Joe Kiani be ousted from his position https://t.ly/iMIPc

With the FDA this week releasing their industry guidance for diversity action plans in clinical trials we wanted to review these updates and get YOUR thoughts! 📊 Will these new guidelines be enough to stop the under-representation of communities we historically see? ⏱ What impact will these guidelines have on participant recruitment? Will this slow down the regulatory process? 🌍 Are these changes seen globally? Which regions would you like to see improve regulations in order to ensure medical devices are safe for the entire population? ❓ Have any vulnerable patient groups been left behind in these regulations? What work still needs to be done to ensure equity for medical device users? 👇 Let us know your thoughts in the poll and comment below! 👇