"Relevium Medical plans to raise €10 million in its next funding round to fund clinical trials for its injection-based treatment for knee osteoarthritis!" https://lnkd.in/e7E5Zama
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Retriever Medical 𝗹𝗮𝘂𝗻𝗰𝗵𝗲𝘀 𝗦𝗲𝗿𝗶𝗲𝘀 𝗔 𝗳𝘂𝗻𝗱𝗶𝗻𝗴 𝗿𝗼𝘂𝗻𝗱 𝘁𝗼 𝗮𝗱𝘃𝗮𝗻𝗰𝗲 𝘁𝗵𝗿𝗼𝗺𝗯𝗲𝗰𝘁𝗼𝗺𝘆 𝘀𝘆𝘀𝘁𝗲𝗺 💰 Retriever Medical is seeking $10M in Series A funding to drive their novel thrombectomy system for treating pulmonary embolism (PE) and deep vein thrombosis (DVT) through FDA clearance and clinical studies. 🔥 They've raised $3.5M to date and are partnering with leaders like Resonetics and Midwest Interventional Systems, Inc. 🩸 Their unique dual-basket, drug-eluting mechanical thrombectomy device paired with aspiration and reinfusion is poised to make a major impact in the rapidly growing venous thromboembolism market. 📈 The venous thromboembolism treatment market has huge potential - with the likes of Inari Medical projecting $575M in revenue this year while only tapping 25% of the available patient population who are currently treated with anticoagulants. #Thrombectomy #MechanicalThrombectomy #Vascular #MedTech
Retriever Medical launches Series A funding round to advance thrombectomy system
https://www.massdevice.com
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Under current CLIA guidelines, CMA only reviews laboratory-developed tests for analytic validity (whether a test measures what it claims to measure), not clinical validity (whether a test is meaningfully associated with the presence or absence of disease) nor clinical utility (whether a test improves patient outcomes). The FDA recently proposed a rule change that would formally classify LDT's as medical devices. As a medical device, an LDT would be subject to an FDA review of safety and effectiveness as well as requirements related to labeling and reporting. The authors note that given the recent proliferation of commercially marketed assays for common diseases, the need exists for closer regulatory oversight, particularly with respect to those LDT's that have the greatest potential to cause patient harm.
Modernizing Federal Oversight of Laboratory-Developed Tests — Toward Safety, Validity, and Utility | NEJM
nejm.org
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🚀 Irish medical device firm Ceroflo announced it has raised €6.4 million in investment-round funding, to help develop its SubMax device—a novel stent intended to “revolutionise” intracranial atherosclerotic disease treatments. 📣 CEO Chloe Brown commented: "We are approaching the problem with a unique understanding of the challenges and are designing the technology with clinicians who have more than 50 years’ collective experience treating this disease. [...] This €6.4 million investment will enable Ceroflo to bring the SubMax stent to 30 patients in a first-in-human trial—a significant value inflection point. It will also allow us to provide a platform to support further US and Japanese regulatory studies.” 👉 Read more: https://lnkd.in/di884E5J 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/dJqiv63c #MedicalDevices #MedicalDevice #MedicalEquipment #Medicine #Surgeons #GuidedSolutions #Investment #FundingRound
Ceroflo raises €6.4 million to aid progress of novel ICAD stroke treatment
https://news.guidedsolutions.co.uk
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Check out this recent interview of Adam Hattan our VP of Marketing & Business Development, by Anne Staylor of SmartTRAK / BioMedGPS, LLC discussing the latest news on #Route92Medical and SUMMIT MAX, the first randomized controlled trial to evaluate safety and effectiveness of "super-bore" 0.088" aspiration catheters. Read more to hear about how #Route92Medical is advancing #neurointervention.
Check out my recent interview with Adam Hattan, Route 92 Medical's (R92) VP of marketing and business development. R92 is raising the bar and advancing the treatment of #acuteischemicstroke through its 250-patient SUMMIT MAX clinical trial, the first randomized controlled trial to evaluate the safety and effectiveness of “super-bore” 0.088” aspiration catheters. Enrollment is now completed in SUMMIT MAX and Adam discusses the latest news on the trial, company and products in our interview. SmartTRAK / BioMedGPS, LLC #medicaldevices #stroke #neurointervention #aspirationthrombectomy #neurovascular
Route 92 Medical: Raising the Bar in Neurovascular Thrombectomy
blog.smarttrak.com
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Boston Scientific to acquire Relievant Medsystems, Inc. for $850 million. The number of companies attempting to conquer the chronic pain burden with spinal cord stimulation (SCS) globally continues to grow, fail, rebrand, acquire, and redefine the space. Medtronic announced 510k of it's Inceptiv closed-loop system earlier this month in Europe, further validating that technology as the future of SCS. Meanwhile, Saluda Medical continues to revolutionize the arena with Evoke, the first-to-market closed-loop system. With SmartSCS it can automatically adjust stimulation to maintain precise and consistent neural activation to the spinal cord for the treatment of intractable low back and leg pain. Patients want to have options. They can now test drive several, using data to help decide what works best for their lifestyle. #spinalcordstimulation #neuromodulation #acquisition
Boston Scientific Announces Agreement to Acquire Relievant Medsystems, Inc.
news.bostonscientific.com
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Arizona-based Nectero Medical, Inc. has initiated a Phase II/III trial evaluating the safety and efficacy of its endovascular aneurysm stabilisation treatment. It is a single-use, endovascular system made up of a dual-balloon delivery catheter and stabiliser mixture of pentagalloyl glucose (PGG). The PGG, when administered locally, can bind to elastin and collagen to potentially strengthen the aortic wall. Animal studies have shown that PGG can hinder the development of abdominal aortic aneurysm (AAA). 👏Congratulations to Jack Springer and the team and wishing them best of luck in future trials. 👉You can read more about their trial here: https://lnkd.in/dedE2Gyr 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/dz3pZQKe #MedicalDevice #Aneurysm #ClinicalTrial #GuidedSolutions
Nectero starts clinical trial for endovascular aneurysm stabilisation system
https://news.guidedsolutions.co.uk
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At this year’s European Society of Minimally Invasive Neurological Therapy (ESMINT) congress, which took place in September in Marseille, France, our CEO Dr. Bassil Akra has participated in the Round Table Discussion "R&D meets FDA and CE authorities". Read the article from NeuroNews to learn more about the discussions on challenges with regard to disparities between the regulatory systems in Europe and the USA, but also about Dr. Bassil Akra's presentation focussing on advice on how best to navigate a neurovascular device through the current European regulations: https://lnkd.in/e4XihyV7 #ESMINT #RegulatoryAffairs #NeurovascularDevices
"The tables have turned"—US FDA regulation is becoming the envy of Europe
https://neuronewsinternational.com
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🎉 News Alert! 🎉 As broke by Andrew J. Sauer, MD , Acorai has been designated a breakthrough device by the U.S. FDA! 🏥 This incredible milestone brings us one step closer to making a difference in the lives of the 64 million global patients suffering from heart failure. ❤️🌍 We couldn't have achieved this without the support and collaboration of countless individuals, organizations and Investors . 🙌🤝 A big thank you to all our amazing partners! 🤗 Stay tuned, because we're just getting started! 🚀📅 We can't wait to share more thrilling updates with you all in the coming months as we progress towards approval. 🎉 Together, let's pave the way for a healthier future! 💪❤️ #BreakthroughDevice #HeartFailureTreatment #AcoraiJourney #ExcitingNews #HealthcareRevolution #PatientOutcomes #HealthTech #MedicalResearch #HeartFailure #Research #ScientificBreakthrough #MinervaJournal #ClinicalStudy #GlobalResearch #HealthcareAdvancements #Collaboration #MakingADifference #medtech #startup #lifescience #cardiology #MedicalDevices #healthcare #ai #future #Acorai #HeartFailure #aimedicine Acorai receives Breakthrough Device Designation for their non-invasive intracardiac pressure monitor https://lnkd.in/eNUcwTVP
Acorai receives Breakthrough Device Designation for their non-invasive intracardiac pressure monitor
prnewswire.co.uk
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