Ryvex’s Post

Explore the forefront of #medical innovation with real-time diagnostic devices leveraging cutting-edge technology. From DNA microarrays to lab-on-a-chip (LoC) microsystems, witness a paradigm shift in #healthcare, enabling personalized #diagnostics and precise disease management. https://lnkd.in/dpm8vu4h #Microfluidics #PolymerFabrication #medicaldevices #injectionmolding #labonachip

Today, there is an escalated appetite to address intravascular lithotripsy, a procedure utilized to break calcified lesions in arteries throughout the body.    We’re proud to be one of several companies committed to improving the lives of patients with calcific peripheral artery disease, and it is great to be recognized by Medical Device Network as one of the novel technologies that will address areas of opportunity in the current market to improve patient outcomes.   Learn more about the POWER PAD II clinical study, which will evaluate the safety and efficacy of our Pulse IVL System in up to 120 patients, in this recent Medical Device Network article: https://lnkd.in/ezxD9sHK    #medtech #medicaldevices #IVLAmplified 

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.

🆕MDCG 2020-16 rev. 3 🆕 was published today. This updated guidance document is adding the definition of a kit (a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof), and is revising the examples of rule 3(a) for identification of sexually transmitted agents; rule 4(a) for self-testing devices, rule 5(c) for specimen receptables, and rule 6 for devices not covered by the other rules. #medicaldevices #IVDR #MDCG #LDPConsulting https://lnkd.in/dbM-9n6r

Exciting news in the medical device world! SonoVascular, Inc. and Lantheus have joined forces to develop the innovative SonoThrombectomy System for treating deep vein thrombosis and pulmonary embolism. This cutting-edge system integrates ultrasound, microbubbles from Lantheus, a low-dose thrombolytic drug, and mechanical retrieval/aspiration - all delivered via an intravascular catheter. By leveraging microbubble-mediated cavitation, it aims to tackle clots more effectively than existing interventional devices. The goal? Reduce clot burden, minimize thrombolytic dosage/duration, optimize safety and efficacy, and eliminate the need for intensive care - a potential game-changer for venous thromboembolism treatment. First-in-human trials are on the horizon this year after successful preclinical studies. Lantheus chief business officer Etienne Montagut said: “We are excited to partner with SonoVascular to extend our microbubble franchise into a novel treatment for VTE. “Our collaboration with SonoVascular leverages both companies’ strengths to help change the paradigm in the treatment of venous disease – a large and growing clinical condition.” This collaboration marries SonoVascular's innovative technology with Lantheus' expertise in microbubbles. We are excited to see the impact this novel approach could have on improving patient outcomes and advancing thrombectomy procedures. Stay tuned for more updates! https://lnkd.in/ejpmNTm9 Be sure to follow Practical Patient Care on LinkedIn for more industry news and insights. You can also read out latest edition: https://lnkd.in/e39XTWsB #PracticalPatientCare #SonoThrombectomy #VenousThromboembolism #MicrobubbleTherapy #DVTtreatmen

A three-day event on the medical balloon revolution! From the roots to the broader horizons 🌅 Here some thoughts that i wrote down to stick in my mind during my drive (actually train) back to Milan: 💪🏻Max effort for an adeguate lesion preparation to achive adeguate acute lumen gain and plaque rupture/debulking (ballon to artery ratio 1:1) 🙅🏻Avoid residual stenosis > 30 % and flow limiting dissection: parallel pressure wire looking to Pd/Pa as a good tool to monitor flow pre- and post- up to several minutes after final balloon. 🤯No class effect for DCBs: specific ballons comparison need specific trials. ✈️Drug to target delivery: crystalline formulations could fracture during passage through tortuous vessels (could encapsulation be the best choice in such cases?). ⛳️Drug retention at target: Paclitaxel has a fast absortion at peak followed by a rapid decrease and long retention while Sirolimus has a slower one followed by a shorter and more stable retention during time. 💊Drug mechanism: Paclitaxel has an irreversibile effect causing citoxicity and a drastic arrest on cells proliferation and migration (might be the best drug option for early aggressive biological ISR? in particular in diabetic patients?) 🪴De novo small vessel > DCBs seems to be a valid alternative/integration to DES (BASKET SMALL 2 trial). Specific sirolimusCB NOT NON inferior (late lumen gain at 6 months) to PaclitaxelCB (TRANSFORM I RCT). 🪵 ISR > DCBs vs DES (comparable efficacy in BMS-ISR but DES more effective in DES-ISR). Comparable efficacy (LLL at 6 months) between specific SCBs and PCBs. 🧲DES and DCBs has a class Ia indication for the treatement of ISR…but, for the moment…DES has a class Ia indication for the treatement of de novo lesions. The best is yet to come. Thanks to everyone.

Have you ever wished for more substantive data behind the bone grafts you use? It’s rare to see a patient and observer-blinded, randomized, intra-patient controlled, multi-center clinical trial…for a bone graft. It’s even rarer to see the following kind of level 1 data. ¹˒²  MagnetOs (used standalone) achieved nearly twice the fusion rate of autograft (minimum 50% iliac crest): 𝟳𝟵% 𝗠𝗮𝗴𝗻𝗲𝘁𝗢𝘀 (101/128 levels) vs. 𝟰𝟳% 𝗮𝘂𝘁𝗼𝗴𝗿𝗮𝗳𝘁 (60/128 levels). And it was 𝗺𝗼𝗿𝗲 𝘁𝗵𝗮𝗻 𝗱𝗼𝘂𝗯𝗹𝗲 in smokers (𝟴𝟬% 𝗠𝗮𝗴𝗻𝗲𝘁𝗢𝘀 vs. 𝟯𝟮% 𝗮𝘂𝘁𝗼𝗴𝗿𝗮𝗳𝘁). View our abstract of this study → https://lnkd.in/dGYieWqb Or Schedule a meet the expert to discover why → https://lnkd.in/gTV-zSvJ

Scopio Labs secures FDA nod for digital bone marrow aspirate application The digital application is designed to run on the company’s X100 and X100HT platforms, to transform the BMA analysis with a new, fully digital workflow. The solution combines high-resolution full-field imaging with an AI-powered decision support system (DSS), to benefit healthcare professionals and patients. It enables hematopathologists to remotely access and review bone marrow smears, reducing turnaround time, and enabling collaboration, expert second opinions, and diagnostic confidence. Scopio Labs CEO Itai Hayut said: “We commend the FDA for acknowledging the essential need to support haematology experts in their complex work. “The approval of the FF-BMA Application arms them with robust decision support systems. “By harnessing AI and Full-Field imaging, labs can streamline workflows, reduce operational costs, and enhance patient care.” Bone marrow cytology refers to the microscopic analysis of cells in bone marrow samples, and is a key diagnostic tool used to identify a wide range of blood disorders. Read more online: https://lnkd.in/eufMEKcm 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #scopiolabs #haematology

Revolutionizing Patient Care: The Power of In Vitro Diagnostics…. https://lnkd.in/dHVgYkqz #IVD #diagnostics #precisionMedicine #medicaltesting #healthcareInnovation #labmedicine

Discover the future of healing with Gladiator Therapeutics. Based on scientific evidence, our patented far infrared therapy devices promote healing from tissue damage and surgical recovery. Experience pain relief, improved circulation, and relaxation with our range of therapy options. https://ow.ly/MprK50SJwlR #GladiatorTherapeutics #FarInfraredTherapy #ScientificallyProven #MedicallyBacked #PatentedTechnology