Safeguarding Scientific Publishing From AI Hallucinations and Fabricated Citations
A 2025 Science study found that 13.5% of biomedical abstracts published in 2024—over 200,000 papers—were drafted with AI assistance, exposing a surge in AI‑generated content. Researchers and medical‑affairs teams are now confronting AI hallucinations, including fabricated citations that can slip past peer review. The article highlights how these errors threaten the reliability of clinical decisions, regulatory submissions, and patient safety. It also outlines emerging safeguards such as document‑grounded models, structured prompts, and iterative validation layers to restore trust.
FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results
The FDA has sent reminders to more than 2,200 medical‑product companies and researchers, covering over 3,000 registered trials, to file required results on ClinicalTrials.gov. An internal analysis shows that 29.6% of studies likely subject to mandatory reporting still have no...
The Healthcare Burnout Backlash (Pt 3): How Workflow Redesign Is Helping Healthcare Organizations Offset Staffing Shortages
The third installment of MedTech Intelligence’s burnout series argues that staffing shortages are symptoms of outdated, siloed workflows rather than pure labor deficits. Healthcare leaders are turning to targeted workflow redesign—especially in patient access, revenue cycle and EHR processes—to eliminate...
BD Announced Application of CE Mark for the Liverty TIPS Stent Graft
BD announced that its Liverty TIPS Stent Graft has received CE Mark approval, allowing sales across the European Union. The next‑generation device features an adjustable 6–10 mm inner diameter and the longest range of covered TIPS stent lengths, aimed at personalizing...
Endospan Receives FDA Approval for the NEXUS Aortic Arch Stent Graft System
Endospan announced FDA approval of its NEXUS Aortic Arch Stent Graft System, clearing the way for a U.S. commercial launch. The clearance was based on one‑year results from the TRIOMPHE IDE study, which demonstrated safe and effective treatment of high‑risk...
InVera Medical Receives FDA Clearance for Non-Thermal Chronic Venous Disease Device
InVera Medical secured FDA 510(k) clearance for its InVera Infusion Device, a 5Fr catheter with a helical coil designed to improve sclerotherapy delivery for chronic venous disease (CVD). The non‑thermal, minimally invasive tool prepares the vein wall mechanically, allowing a...
The Healthcare Burnout Backlash (Pt 2): Positioning AI Pilots for Success Within EHR-Integrated Environments
Healthcare administrators are grappling with AI pilots that operate alongside, rather than within, electronic health‑record (EHR) systems, creating hidden operational risks. While early pilots can move quickly by using separate data environments, the lack of seamless integration leads to traceability,...
Serenity Medical Receives FDA Humanitarian Device Exemption for IIH Venous Stent
Serenity Medical has secured an FDA Humanitarian Device Exemption for its River venous stent, the first cerebral venous stent cleared for severe, refractory idiopathic intracranial hypertension (IIH). The approval follows the River Study, a multicenter trial of 39 patients that...
FDA Publishes New Set of Real-World Evidence Examples
The U.S. Food and Drug Administration’s Center for Devices and Radiological Health released a new collection of 73 real‑world evidence (RWE) examples that illustrate how medical device marketing authorizations have been supported by real‑world data from fiscal years 2020 through...
How Rural Health Systems Are Advancing Cardiac Imaging
Rural health systems are deploying cardiac CT scanners to bring high‑resolution, non‑invasive heart imaging to underserved areas. The technology delivers scans in about 15 minutes, enabling clinicians to avoid invasive catheterizations for 77% of patients and cut diagnostic costs by...
Beyond Reimbursement: Why Market Access Is MedTech’s Strategic North Star
The article argues that Market Access (MA) has moved beyond a narrow reimbursement focus to become a strategic engine for MedTech firms. Insights from BCG roundtables and industry leaders highlight new MA capabilities—experts, stewards, and integrators—that drive product adoption, pricing...
CDRH Guidance: Patient Preference Information (PPI) in Medical Device Decision Making
On March 27, 2026 the FDA’s Center for Devices and Radiological Health issued new guidance on incorporating voluntary patient preference information (PPI) throughout a medical device’s total product life cycle. The document supersedes the 2020 guidance and details when and...
Apple Store to ID Regulated Medical Device Apps
Apple’s App Store will now label apps that qualify as regulated medical devices on their product pages in the United States, United Kingdom and European Economic Area. Developers must indicate this status in App Store Connect if their app falls...
HL7 Launches Real‑Time Medical Device Interoperability Accelerator
On March 5, 2026, HL7 International launched the Caliper FHIR Accelerator, an implementation community aimed at real‑time medical device data interoperability. The initiative builds on HL7’s 2025 device‑workgroup and aligns with standards from IEEE, ISO, IEC, and IHE. By extending...
Two GA Tech ATDC Startups — Nephrodite and OrthoPreserve — Secure FDA Breakthrough Device Designation
Georgia Tech’s Advanced Technology Development Center announced that two of its HealthTech portfolio companies, Nephrodite and OrthoPreserve, have each received the FDA’s Breakthrough Device designation. The program promises accelerated regulatory interaction, more frequent agency meetings, and priority review. Nephrodite’s solution...