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.
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 full transformation work is actually being carried...or its impact across healthcare.
Nephrodite’s technology improves the lives of dialysis patients. OrthoPreserve’s device addresses challenges faced by those who suffer from chronic knee pain.
What we’re reading on LinkedIn… Review of leading healthcare AI reports illustrate several conditions creating fertile ground for applied AI in healthcare operations.
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).
Data has become overwhelming in healthcare. While it has provided tremendous solutions and outcomes, however, it can sometimes be a problem, too! How can data utilization in Clinical Studies and a ground up data strategy help make your technologies, your team, and your trials more efficient?
FDA clearance of the BCL System will give surgeons access to precise information about each breast tumor that has never before been available to them, according to the company.
Mindray says its entry into the ventilator market marks a significant step in expanding advanced respiratory care options for clinicians and patients, reinforcing the medical device leader’s commitment to driving innovation in healthcare.
Hypoglossal nerve stimulation therapy approved in the U.S. without complete concentric collapse contraindication or warning language. The next-generation, MRI-compatible device is expected to launch in the first half of 2027, pending FDA supplement review.
Perfuze states the Millipede88 is the first 088 aspiration catheter with patented corrugated technology cleared for standalone direct aspiration — no large-bore intermediary required — backed by independently adjudicated MARRS study data showing a 77% first-pass effect1 in M1 occlusions and 96% delivery success.
The medical device industry and EPA have been in ongoing debate over balancing the need for sterile medical equipment with concerns about pollution near sterilization plants.
The Urocross Expander System is designed to remodel the obstructing prostatic lobes during the six-month indwell time and is intentionally retrieved, leaving no permanent foreign material behind.
To achieve medical Device Interoperability, system boundaries need to be defined, system architecture needs to be aligned, and interfaces and communication protocols need to be established across individual components of the medical device. In some cases, it is as important to design and implement QMS Interoperability as it is to design Device Interoperability.
On February 2, 2026, the FDA stopped using the Quality System Inspection Technique (QSIT) for device inspections and began utilizing the inspection process described in the updated Inspection of Medical Device Manufacturers Compliance Program (CP) Manual (CP 7382.850).
The FDA launched The Adverse Event Monitoring System (AEMS), calling it a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.
