News
FDA Publishes New Set of Real-World Evidence Examples
15+ hour, 6+ min ago (226+ words) New set of 73 Real World Evidence examples illustrate how RWD can support rigorous validation of novel device software functions across multiple disease areas. This Blog Post was originally published on FDA.gov By: Daniel Ca'os, Ph.D., MPH, Director, Office of…...
Google News
2+ day, 19+ hour ago (9+ words) How Rural Health Systems Are Advancing Cardiac Imaging'MedTech Intelligence...
The Human Side of AI Medical Devices: Why Safety Depends on Design, Not Just Algorithms
2+ day, 20+ hour ago (712+ words) Shreya Sridhar is a principal systems engineer at Medtronic specializing in software as a medical device (SaMD) and AI-enabled healthcare technologies. She leads the design and integration of complex medical device software systems, with a focus on system architecture, safety-driven…...
CDRH Guidance: Patient Preference Information (PPI) in Medical Device Decision Making
4+ day, 8+ hour ago (163+ words) The Center for Devices and Radiological Health (CDRH) posted new PPI guidance on FDA.gov on March 27, 2026. The Urocross Expander System is designed to remodel the obstructing prostatic lobes during the six-month indwell time and is intentionally retrieved, leaving no…...
Apple Store to ID Regulated Medical Device Apps
4+ day, 9+ hour ago (152+ words) If you distribute in the EEA, UK, or U.S. and your app meets either of the following criteria, you'll need to provide a regulated medical device status in App Store Connect, along with relevant regulatory information, such as contact details and…...
The Healthcare Burnout Backlash (pt 1): Burnout Reaches Well Beyond Clinicians
6+ day, 14+ hour ago (626+ words) In this part 1 of a 4-part series, we look at how the burden of digital transformation is impacting the entire healthcare ecosystem, and that while burnout in healthcare is most often framed around clinicians, it does not reflect where the…...
Two GA Tech ATDC Startups — Nephrodite and OrthoPreserve — Secure FDA Breakthrough Device Designation
1+ week, 20+ hour ago (270+ words) Achieving this milestone, according to a univeersity press release, underscores the caliber of founders, science, and support in ATDC's 30-company HealthTech portfolio, the incubator's largest focus area. It's also a win for Georgia because it reflects the strength of the…...
HL7 Launches Real‑Time Medical Device Interoperability Accelerator
1+ week, 20+ hour ago (286+ words) This fragmentation is a well-known challenge in healthcare IT. On March 5, 2026, HL7 International took a major step toward solving it with the launch of the'Caliper FHIR" Accelerator,'a new implementation community dedicated to improving how data from medical and personal health…...
Artificial Intelligence: ROI, not Clinical Autonomy, Leads Operational Workflows
1+ week, 20+ hour ago (125+ words) Review of leading healthcare AI reports illustrate several conditions creating fertile ground for applied AI in healthcare operations. The integration of technology and connectivity into healthcare is not only improving patient outcomes but also reshaping the way care is delivered....
Breakthrough Device Designation for Noah Labs Vox Heart Failure Detection Device
1+ week, 21+ hour ago (186+ words) Noah Labs Vox," a voice-based algorithm that detects worsening heart failure weeks before hospitalization, has received US Food and Drug Administration (FDA) Breakthrough Device Designation (BDD). "Voice is a powerful predictor for worsening heart failure, explains CEO and Co-founder Oliver…...