FDA Publishes New Set of Real-World Evidence Examples
New set of 73 Real World Evidence examples illustrate how RWD can support rigorous validation of novel device software functions across multiple disease areas.
CDRH Guidance: Patient Preference Information (PPI) in Medical Device Decision Making
Patient Preference Information (PPI) guidance on when and what methods to use to collect and submit patient preference information (PPI) for a device to FDA.
BSCI’s LAAC CHAMPION-AF study for WATCHMAN FLX meets primary and secondary safety and efficacy endpoints
Data highlights the WATCHMAN FLX device provided statistically superior protection from bleeding, demonstrated similar efficacy compared to blood thinners in patients with non-valvular atrial fibrillation. Findings presented at ACC.26 and simultaneously published in The New England Journal of Medicine.
Apple Store to ID Regulated Medical Device Apps
To provide additional transparency on the App Store, apps that are available in the European Union (EU)/European Economic Area (EEA), United Kingdom (UK), or United States (US), and that also meet either of the criteria listed below must indicate whether they’re regulated medical device with respect to each region’s regulatory authority or body responsible for the governance and compliance of medical devices.
Where are you with EUDAMED?
EUDAMED is mandatory at the end of May and many manufacturers aren’t ready.
HL7 Launches Real‑Time Medical Device Interoperability Accelerator
New implementation community builds on global collaboration to improve
real-time device data exchange for AI-enabled care.
Two GA Tech ATDC Startups — Nephrodite and OrthoPreserve — Secure FDA Breakthrough Device Designation
Nephrodite’s technology improves the lives of dialysis patients. OrthoPreserve’s device addresses challenges faced by those who suffer from chronic knee pain.
Artificial Intelligence: ROI, not Clinical Autonomy, Leads Operational Workflows
What we’re reading on LinkedIn… Review of leading healthcare AI reports illustrate several conditions creating fertile ground for applied AI in healthcare operations.
Medtronic and Merit Medical Systems distribution agreement for new, ViaVerte basivertebral nerve ablation system
Exclusive agreement expands Medtronic’s comprehensive pain interventions portfolio, increases treatment options for patients living with chronic pain.
Breakthrough Device Designation for Noah Labs Vox Heart Failure Detection Device
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).