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As cardiac medical devices become more connected and rely on AI, cybersecurity must be a top priority. The FDA’s recent guidelines stress the importance of integrating cybersecurity throughout the product lifecycle, from design to post-market monitoring. Manufacturers are encouraged to adopt a Secure Product Development Framework (SPDF), conduct routine risk assessments, and maintain thorough cybersecurity documentation to protect patient data and device integrity. In the age of digital health, robust cybersecurity is essential for ensuring both device safety and patient trust. Check out our latest blog post to learn more about cardiac medical devices: https://bit.ly/3UJqCYp #Cybersecurity #MedicalDevices #FDA #DigitalHealth #CardiacCare #Quroba

Software as a Medical Device (SaMD) is a key player in modern cardiac healthcare. From real-time monitoring apps to AI-powered diagnostics, SaMD applications offer flexibility and rapid response to patient needs. The FDA’s risk-based framework for SaMD ensures that the regulatory process aligns with the device’s intended use and potential risk to patient health. This framework encourages innovation while maintaining strict standards for performance and transparency—especially in AI-integrated applications. Want to learn more? Check out our latest blog! https://bit.ly/3UJqCYp #SaMD #CardiacTechnology #MedicalSoftware #FDA #HealthcareInnovation #Quroba

AI is rapidly transforming the cardiac device space. From predictive analytics to personalized treatment algorithms, AI is enabling more precise and effective cardiac care. But with this innovation comes a regulatory challenge. The FDA has adopted a Total Product Lifecycle (TPLC) approach for adaptive AI, allowing real-time monitoring and continuous updates to ensure ongoing safety and efficacy. This evolving regulatory framework supports innovation while maintaining patient safety—a delicate balance for manufacturers to strike. Want to learn more about AI's role in advancing Cardiac Medical devices? Check out our latest blog here: https://bit.ly/3UJqCYp #ArtificialIntelligence #CardiacCare #MedicalDevices #FDA #Innovation #Quroba

Navigating the regulatory landscape for cardiac medical devices can be challenging. Whether your device follows the 510(k) pathway (for lower-risk devices), PMA (for high-risk devices like implantable defibrillators), or IDE (for investigational devices), each has its own requirements. Choosing the right regulatory path is crucial to ensure patient safety and timely market entry. ?? Need help understanding which pathway is right for your device? Learn more in our latest blog post: https://bit.ly/3UJqCYp #MedicalDevices #Cardiology #RegulatoryCompliance #FDA #HealthTech #Quroba

Unfortunately due to scheduling conflicts, we will be postponing our scheduled event tomorrow (Tuesday), August 20th. We hope to announce the rescheduled date soon! Please follow along for further updates. Thank you all for your patience! ?

?? SAVE THE DATE! Your friends at Quroba will be hosting a LIVE panel on Tuesday, August 20th, at 5:00PM in beautiful Old Town Pasadena! Hear from industry leaders as they discuss how regulatory and quality compliance can help you and your company reach their goals in fundraising, sales, and growth. Join our guestlist now! https://lu.ma/uf7rmg4a We'll have good food and even better discussions ?? More details coming soon! #Quroba #LivePanel #QualityAndRegulatory #Compliance

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???? It’s National DNA Day! ???? Last year, the FDA greenlit the first-ever DNA test designed to assess the risk of opioid use disorder. Developed by Autogenomics, this groundbreaking test utilizes DNA analysis to identify individuals who may be predisposed to opioid dependence. Previously, an earlier iteration of this test faced rejection from the FDA. However, after refining the test, Autogenomics has successfully navigated the regulatory landscape to receive approval from the FDA. By identifying individuals at higher risk of opioid use disorder prior to surgery or planned procedures, healthcare professionals can tailor their treatment plans accordingly. This empowers both patients and providers with valuable insights to make informed decisions regarding pain management strategies. Want to learn more about the test? Visit https://bit.ly/3TyMvt1 #DNADay #OpioidUseDisorder #FDA

Today, we're thrilled to shine our Connection Feature on Dr. William Harrity! As an everyday practicing board-certified cardiac anesthesiologist across four hospitals in the Los Angeles area, Dr. Harrity brings a wealth of clinical expertise to the table. But his contributions don't end there – Dr. Harrity is also the visionary inventor behind AutoPress, a groundbreaking blood pressure “autopilot” that is revolutionizing the realm of medical technology. With many years of hands-on patient care and countless clinical hours under his belt, Dr. Harrity has a keen eye for identifying challenges within the hospital setting and developing innovative solutions to address them. In addition to his groundbreaking work in healthcare, Dr. Harrity is an active member of the Southern California Biomedical Council (SoCalBio) and Los Angeles Venture Association (LAVA) biotech groups in the Southern California area, as well as a skilled pilot with a commercial rating. Connect with him today! #ConnectionFeature #CardiacAnesthesiology #Medtech

Are you wondering if Quroba is the perfect partner for your medtech company? We've got three compelling reasons why we’re a great fit for you! Reach out to us to get started: https://bit.ly/43gzQ13 #Medtech #Quroba