NAMSA’s Post

👍 InnovHeart announced the first trans-septal clinical trial implant of its proprietary Saturn transcatheter mitral valve, which led to excellent hemodynamic results for the patient. The procedure was part of system’s ongoing European clinical trial, the CASSINI-EU study. 👏Best of luck in the trial to the medical team, CEO David Wilson, and CTO Giovanni Righini! 🔗 Learn more: https://lnkd.in/e4RXksht 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/echiXdGC #MedicalDevices #MedicalDevice #MedicalEquipment #Medicine #HealthTech #Surgeons #GuidedSolutions

Exciting news in medical innovation! Signum Surgical has received FDA De Novo clearance for BioHealx, a groundbreaking treatment for anal fistulas. This bioabsorbable implant offers a minimally invasive approach to a painful condition affecting thousands annually. Moshe Zilversmit, Co-Founder and CEO of Signum Surgical, expressed pride in this achievement, emphasizing its potential to enhance patient care. The clearance follows a successful clinical trial involving 32 patients with recurrent anal fistulas. Dr. Peter Ónody, Principal Investigator, highlighted BioHealx's potential to reduce multiple surgeries and lower healthcare costs. This FDA approval marks a significant step towards addressing an unmet clinical need in colorectal care. Signum Surgical is now exploring partnerships to bring BioHealx to market swiftly, offering new hope for patients struggling with this challenging condition. https://lnkd.in/e-pJCxjb 📰 Stay ahead of the curve by following Practical Patient Care on LinkedIn for more industry news and insights. You can also access our latest edition here: https://lnkd.in/guUBWkRE #PracticalPatientCare #MedicalInnovation #FDAApproval #ColorectalCare

1️⃣ Medline Industries, LP agrees to acquire Ecolab’s surgical solutions business for $950 million, with the transaction expected to be completed in the second half of 2024. 2️⃣ Optomed Plc launches the Aurora AEYE, an AI fundus camera for instant diabetic retinopathy detection, designed for primary care settings. 3️⃣ Thermo Fisher Scientific has launched the CXCL10 test for kidney transplant patients, targeting elevated urinary CXCL10 levels associated with inflammation and early kidney transplant rejection. 4️⃣ NovaScan has selected Epredia to distribute its MarginScan device in the US, aiming to improve surgical outcomes by minimizing the removal of healthy tissue during excisions. 5️⃣ SonoVascular, Inc. has partnered with Lantheus for venous thromboembolism (VTE) treatment, where Lantheus will supply microbubbles and activation devices, while SonoVascular handles clinical studies. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

Evolus has announced impressive results from its U.S. pivotal study of Evolysse™ dermal fillers. Evolysse™ Lift demonstrated superiority to Restylane-L at 6 months, with significant improvements in nasolabial fold (NLF) severity over 12 months. Evolus is on track to submit Premarket Approval applications for Evolysse™ Lift and Smooth to the FDA within the next 90 days. These new dermal fillers will expand Evolus' market presence, complementing its flagship neurotoxin, Jeuveau®. Dr. Rui Avelar, MD, Chief Medical Officer, highlighted the consistency of these results with previous European trials. Dr. Steven Dayan, an investigator in the trial, praised the precision and efficacy of the Evolysse™ line. This achievement underscores Evolus' commitment to innovation in the aesthetics industry. #Evolus #Evolysse #DermalFillers #Aesthetics #FDAApproval #Innovation #BeautyIndustry

#LIFTTportfolio | Another great milestone for our #portfoliostartup Lipogems International! The clinical stage- global medical technology company, announces the first patient enrolled in the ARISE II U.S. FDA IDE research study, which aims to examine investigational MicroFat versus saline injection for the treatment of Knee Osteoarthritis (OA). 👏 Find out more in the article below: 👉 Aurora Castello Guido Panizza #Osteoarthritis #biotechnology

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

Patients with acute and chronic pain often face a crisis because of significant challenges in obtaining adequate care, resulting in profound physical, emotional, and societal costs. Pulsed electromagnetic field (PEMF) technologies have shown usefulness as adjunctive therapy for both post-operative and chronic wounds. These relatively simple devices use an external, non-invasive PEMF to generate short bursts of electrical current in injured tissue without producing heat or interfering with nerve or muscle function. An increased understanding of the mechanism of action of PEMF therapy has permitted technological advances yielding economical and disposable PEMF devices, such as SofPulse. Plastic surgery has become a prime focus for such post-operative uses. SofPulse PEMF therapy treatment is being used in the management of postoperative pain and edema in both outpatient and home settings offering the physician a more versatile tool for patient management. A plastic surgeon who routinely uses SofPulse in his practice told me about a recently performed facelift on a 47-year-old male. This is often a very painful procedure requiring a few days of pain medication. SofPulse was used on this patient immediately after the conclusion of the procedure. Within a few hours, he was feeling no pain. Both the patient and the surgeon reported less swelling (edema) and less inflammation. Additionally, there was far less scarring and improved healing. This is where SofPulse shines. SofPulse works regardless of the cause or pathology of the acute pain. In over 20 thousand cases to date, SofPulse has worked without any reported adverse events. SofPulse patients experience an effective treatment for their pain – and feel better quickly. Are you or someone you know planning on undergoing a surgical procedure such as a joint replacement, cardiac bypass surgery, or another procedure? Are you or they anxious about the post-surgery recovery? Are you or they concerned about taking drugs to manage the pain? SofPulse is the only available non-pharmaceutical, FDA-cleared pain management device available in the country for the treatment of post-surgical pain. Our team of pain specialists will guide you or your loved one with a path toward a non-pharmaceutical recovery following surgery. If you or someone you know could use our help, please have them reach out to me at iweisberg@endonovo.com for a free consultation. Contact us for more information. www.sofpulse.com

The latest issue of Endovascular Today highlights Akura Medical’s differentiated approach to #thrombectomy for #VTE. Learn more about our key product innovations and early clinical experience from this informative article by Drs. S. Jay Mathews, MD, MS, FACC, FSCAI, Ehrin Armstrong and Bill Dixon. #innovation #medtech #makingadifference

For many years now Psephos Biomedica have been at the centre of supporting innovative medical technology clients with clinical strategy, evaluations, investigations and PMCF. Integrating clinical strategy and implementation into your device development programme with patient benefits and safety at the forefront, and the regulatory pathway in mind, is critical for success. Let us know if you’d like an early stage discussion… #clinical #medicaldevice #regulatory

Clinical strategy, clinical evidence, and clinical evaluation are central to ensuring medical devices are safe and suitable for human use, approval, and access to global markets. This should be considered early in the development process to efficiently implement the right integrated regulatory and clinical strategy. Psephos can help you do this and has shared two examples of early stage companies they are helping.   BariaTek made their first successful In-Human implantation for their BariTon™ device this month: https://lnkd.in/efeBzJZB   The first UK patient in this ongoing study was fitted with FIRE1 ’s heart failure sensor the size of a pen lid last year: https://lnkd.in/ePw84krr Get in touch with Psephos Biomeidca to see how they can help you: https://lnkd.in/ex797CUr #clinicalstrategy #clinicalevaluation #medicaldevice #fda #ce #ukca #clinicaltrials #clinicalevidence #psephosbiomedica Robin Stephens