Allevion Medical Receives FDA Clearance for Vantage™, Introducing a Fully Disposable Approach to Minimally Invasive Spinal Decompression.
The post Allevion Medical Receives 510K Clearance for Vantage Spinal Decompression System appeared first on MedTech Intelligence.
In this part 2 of a 4-part series, Melissa highlight how the moment AI begins to influence decisions or workflows, it is operating within a regulated environment. Aligning with documentation standards, keeping data within established pathways, and ensuring actions are consistently recorded are all ways to support that reality early, rather than adapting to it later. Seen this way, integration is not just a technical milestone.
The post The Healthcare Burnout Backlash (pt 2): Positioning AI pilots for success within EHR-integrated environments appeared first on MedTech Intelligence.
New technology designed to provide a single irrigation management system for ureteroscopy, cystoscopy, percutaneous nephrolithotomy (PCNL) and benign prostatic hyperplasia (BPH) procedures.
The post Boston Scientific receives FDA clearance for the Asurys Fluid Management System appeared first on MedTech Intelligence.
The company's River stent will be available for adults with severe IIH – a debilitating, historically undertreated condition – who have failed medical therapy.
The post Serenity Medical Receives FDA Humanitarian Device Exemption for IIH Venous Stent appeared first on MedTech Intelligence.
The acquisition expands Merit’s portfolio of therapeutic oncology products dedicated to the accurate diagnosis and localization of breast and soft tissue tumors.
The post Merit Medical Acquires View Point Medical, Inc., expanding the Merit Therapeutic Oncology Portfolio appeared first on MedTech Intelligence.
New set of 73 Real World Evidence examples illustrate how RWD can support rigorous validation of novel device software functions across multiple disease areas.
The post FDA Publishes New Set of Real-World Evidence Examples appeared first on MedTech Intelligence.
Geography is effectively determining whether patients receive timely cardiac diagnosis, or even any diagnosis at all. In an effort to address the problem, cardiologists and health systems are increasingly looking to cardiac CT to redefine how advanced imaging can be delivered closer to where patients live.
The post How Rural Health Systems Are Advancing Cardiac Imaging appeared first on MedTech Intelligence.
Companies that embed Market Access early in innovation are the ones best positioned to navigate the changing global landscape.
The post Beyond Reimbursement: Why Market Access is MedTech’s Strategic North Star appeared first on MedTech Intelligence.
Human factors engineering plays a critical role in the design of AI-enabled medical devices and whether they might improve care or introduce new risks.
The post The Human Side of AI Medical Devices: Why Safety Depends on Design, Not Just Algorithms appeared first on MedTech Intelligence.
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.
The post CDRH Guidance: Patient Preference Information (PPI) in Medical Device Decision Making appeared first on MedTech Intelligence.
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.
The post BSCI’s LAAC CHAMPION-AF study for WATCHMAN FLX meets primary and secondary safety and efficacy endpoints appeared first on MedTech Intelligence.
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.
The post Apple Store to ID Regulated Medical Device Apps appeared first on MedTech Intelligence.
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.
The post The Healthcare Burnout Backlash (pt 1): Burnout Reaches Well Beyond Clinicians appeared first on MedTech Intelligence.
EUDAMED is mandatory at the end of May and many manufacturers aren't ready.
The post Where are you with EUDAMED? appeared first on MedTech Intelligence.
New implementation community builds on global collaboration to improve
real-time device data exchange for AI-enabled care.
The post HL7 Launches Real‑Time Medical Device Interoperability Accelerator appeared first on MedTech Intelligence.
Nephrodite’s technology improves the lives of dialysis patients. OrthoPreserve’s device addresses challenges faced by those who suffer from chronic knee pain.
The post Two GA Tech ATDC Startups — Nephrodite and OrthoPreserve — Secure FDA Breakthrough Device Designation appeared first on MedTech Intelligence.
What we’re reading on LinkedIn… Review of leading healthcare AI reports illustrate several conditions creating fertile ground for applied AI in healthcare operations.
The post Artificial Intelligence: ROI, not Clinical Autonomy, Leads Operational Workflows appeared first on MedTech Intelligence.
Exclusive agreement expands Medtronic's comprehensive pain interventions portfolio, increases treatment options for patients living with chronic pain.
The post Medtronic and Merit Medical Systems distribution agreement for new, ViaVerte basivertebral nerve ablation system appeared first on MedTech Intelligence.
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).
The post Breakthrough Device Designation for Noah Labs Vox Heart Failure Detection Device appeared first on MedTech Intelligence.
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?
The post Clinical Trials Have Too Much Data…That’s the Problem. appeared first on MedTech Intelligence.
Innovation, implementation & utilization of medical technology
