punktum

Interested in how to navigate medical device compliance? We’ve gathered key insights on regulatory challenges, from MDR and FDA approval to AI validation and cybersecurity risks—along with practical solutions to get it right. Dive in!

📊 MDR Rule 11 in numbers: How medical software classification has changed—and what it means for developers A new study by Arndt A. Schmitz and his team at Bayer analyzed 2,000+ EUDAMED entries and revealed the measurable impact of MDR Rule 11: ➡️ Drop in Class I software – Previously, 53% of software was Class I. Under MDR, only 35% remains in this category, while 55% is now Class IIa. ➡️ Higher regulatory burden – Class IIa requires QMS certification, clinical evidence, and Notified Body approval, significantly increasing time and cost. ➡️ Risk of market withdrawals – Many previously self-certified Class I solutions may not be available after 2028 due to the higher compliance demands. 💡 What does this mean for medical software developers? ✔️ Know your classification early – Avoid delays by assessing MDR requirements from the start. ✔️ Optimize for Class I where possible – Non-diagnostic, non-therapeutic software can still follow a simplified path. ✔️ Plan for longer approval cycles – Class IIa and above require additional resources, certification, and regulatory planning. With stricter regulations reshaping the European market, developers need to rethink compliance strategies early to avoid delays or product risks. Read the full study here: https:https: //rdcu.be/d7RIe #SaMD #MDR #EUDAMED #DHT #DigitalHealth #MedicalSoftware #RegulatoryStrategy

🚀 Transforming Infantile Spasms Diagnosis: The Motus Med App 🚀 Infantile spasms (IS) are a severe epilepsy syndrome affecting 1 in 2,500 infants. Unfortunately, 70% of cases experience delayed diagnosis, often leading to long-term cognitive impairment. motus med, in collaboration with Charité - Universitätsmedizin Berlin and us, has developed an AI-powered mobile app to tackle this issue head-on. Key features include: ✔️ AI Video Analysis: Parents record movements, instantly analyzed by AI. ✔️ Doctor Alerts: Detected signs of IS are shared with healthcare providers. ✔️ Faster Diagnosis: Enabling earlier interventions and better outcomes. We are proud to have contributed to this project by providing AI expertise, regulatory compliance guidance, and a clear roadmap for scaling. A special thank you to the dedicated neurologists at Motus Med and our punktum team for making this innovative solution a reality. Together, we’re setting a new standard for pediatric care. #DigitalHealth #PediatricCare #AI #Epilepsy #InfantileSpasms #ComputerVision #HealthcareInnovation

How can AI truly improve healthcare? What challenges do we still need to overcome? We had the chance to discuss these questions in an interview featured by Merantix AI Campus, where our CEO, Josua Ziegler, spoke about the potential, limitations, and real-world applications of AI in healthcare. To give an example of these real-world applications, he referred to Diaper ID, a project in which we implemented computer vision to support early liver disease detection in newborns—illustrating how AI can assist healthcare professionals in making faster, more informed decisions. A big thank you to Merantix for the opportunity to contribute to this important conversation! Watch the full interview here: https://lnkd.in/eVW5fcUu #AI #DigitalHealth #EarlyDetection #HealthcareAI #NewbornHealth

Great to see CaReHigh take this big step in FH patient care! We’re proud to have contributed our AI and digital health expertise to help bring this solution to life. Excited to see its impact on patients and clinicians. #FamilialHypercholesterolemia #FHManagement #PatientCare #DigitalHealth #PatientCenteredCare

Our COO, Tom Sieron, will be speaking at the Life Sciences Tech Network - Berlin panel on February 10! Join Tom and other thought leaders as they discuss the transformative role of AI/ML in life sciences and healthcare. From opportunities in healthcare innovation and drug discovery to challenges like ethics and scalability, this panel promises valuable insights for the future of our industry. #MachineLearning #Networking #DigitalHealth

Revolutionizing FH Diagnosis and Care Across Germany! We’re honored to have collaborated with Felix Fath, Prof. Dr. Winfried März, and the D•A•CH-Gesellschaft Prävention von Herz-Kreislauf-Erkrankungen e. V. on the CaReHigh project. CaReHigh addresses the challenges of diagnosing Familial Hypercholesterolemia (FH), a genetic disorder affecting 1 in 300 people in Germany. With fewer than 15% of patients diagnosed, FH often goes untreated, leading to missed opportunities for family screening and timely interventions. The CaReHigh-App simplifies patient engagement, supports clinicians, and empowers families by: 📲 Streamlining Patient Engagement 📈 Providing Real-Time Clinical Insights 💡 Empowering Patients Self-Management Thank you to all the collaborators for your trust and partnership. Together, we’re transforming the future of FH research and care across Germany. #FamilialHypercholesterolemia #FHManagement #PatientCare #DigitalHealthInnovation #RemoteMonitoring #CascadeScreening #HealthcareAI

Interested in how Remote Patient Monitoring (RPM) is transforming healthcare? We've gathered some insights on its benefits, applications, and challenges. Dive in!

Recently, Josua Ziegler and Marek S. Tatara, PhD facilitated an AI workshop for Natal Mind, led by their Medical Lead, Aura Pyykönen. It was a pleasure to support their vision of a personalized digital doula solution with actionable AI strategies to enhance maternal care. As Aura shared: “I was genuinely impressed by how quickly they understood our key challenges and jumped straight into brainstorming impactful, tailored solutions for us.” Here’s what we achieved together: -> Clear Priorities: Using Miro, we mapped their challenges and identified areas where AI can provide the most value, such as personalizing care and improving labor monitoring. -> Actionable AI Use Cases: Marek demonstrated specific machine learning approaches to bridge the gap between their expertise and AI’s capabilities. -> Defined Next Steps: Together, we created a clear, strategic plan to implement AI effectively and move forward with confidence. The session didn’t just clarify AI integration - it inspired strategic thinking about areas like personalization and labor monitoring. “The workshop helped bridge the gap between our existing knowledge and where AI ‘steps in,’ which has often been a bit vague for those of us without deep technical expertise.” Aura If you're exploring AI for healthcare, let’s talk about how we can help turn your vision into meaningful outcomes. #AIWorkshop #DigitalHealthInnovation #AIForHealthcare #HealthTech #HealthcareSolutions #MachineLearningApplications

Key themes like transparency, ethical AI, and the balance between human expertise and technology took center stage at MEDigIT Event 2024, where our CEO, Josua Ziegler, joined an insightful panel discussion on “Augmented Intelligence in diagnostic decision-making.” Alongside experts Paul Borm, Simon Max Bloch Lajboschitz, Garnette Sutherland, and YURONG XU, the discussion explored: The role of AI in complementing diagnostics. Ethical and transparent integration of AI in healthcare. Training programs to help clinicians work effectively with AI tools. We’re proud to have contributed to this important dialogue and look forward to continuing our journey in advancing healthcare innovation. #AI #HealthcareInnovation #AugmentedIntelligence #MEDigIT2024