Seven Things Every Medical Device Manufacturer Must Know Before Integrating AI
Artificial intelligence has moved from experimental to production‑ready in healthcare, enabling devices like predictive glucose monitors and AI‑driven oncology tools. For medical‑device makers, integrating AI is now a business imperative but also a complex regulatory undertaking. The article outlines seven critical steps—from early SaMD classification to embedding cybersecurity in the quality system—to ensure compliant, market‑ready AI products. Manufacturers that embed compliance into design can capture first‑mover advantages in a market growing at roughly 44% annually.
The Structural Tension at the Heart of MedTech
The article highlights the inherent tension between the deliberate, evidence‑driven pace of MedTech development and the fast‑moving expectations of venture capital. It argues that accelerating clinical validation to meet investor timelines often backfires, leading to underpowered studies and higher downstream...
Cybersecurity Tactics for Medical IoT Devices
The Internet of Medical Things (IoMT) is projected to surge from $60 billion in 2024 to $814 billion by 2032, driven by real‑time patient monitoring and cost‑saving benefits. However, 2024 saw over 14,000 IoMT IPs exposed, with 36% stemming from unsecured medical...
From Toddlers to Teens: The Hidden Complexities of Bringing Pediatric Wearables to Market
Pediatric wearables face unique challenges beyond miniaturization, requiring designs that adapt to rapidly changing physiological, cognitive, and behavioral traits from infancy to adolescence. Companies must address divergent safety, usability, data reliability, and algorithm performance needs across developmental stages, while managing...
Interoperability Was Never the Finish Line in Healthcare
Mika Newton highlights that while CMS’s Kill the Clipboard initiative is reducing manual data entry, true progress in healthcare requires moving beyond simple data access. Interoperability has succeeded in pulling records from silos, but clinicians still face unstructured, overwhelming information....
Beyond Reporting: Realizing Continuous Safety Surveillance for Medical Devices
Regulators in the EU, UK and US have upgraded post‑market surveillance (PMS) requirements, demanding systematic analysis of device incident data rather than mere reporting. Manufacturers must now adopt analytical, pharma‑style vigilance processes to detect trends, assess risk, and feed findings...
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...
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...
17 Spine Surgery Firsts in Q1
During the first quarter, leading spine surgeons performed a series of first‑in‑human procedures, showcasing new devices and techniques ranging from a standalone ALIF system to augmented‑reality‑guided resections. Notable milestones included Curiteva’s Inspire ALIF, Dymicron’s Triadyme‑C cervical disc, icotec’s CMORE CT...
Mindray North America Enters Ventilator Market
Mindray North America announced the launch of its SV900 and SV700 ventilators, marking the company’s entry into the U.S. respiratory‑care market. As the world’s second‑largest acute‑care ventilator supplier, Mindray is expanding its critical‑care portfolio with devices that combine invasive, non‑invasive...
Perfuze Receives FDA 510(k) Clearance for Millipede88 Aspiration Catheter
Perfuze obtained FDA 510(k) clearance for its Millipede88 Aspiration Catheter after the MARRS clinical study met all primary objectives. The device is the first super‑bore 0.088 catheter cleared for standalone direct aspiration, featuring a patented corrugated design that preserves lumen...
Prodeon Medical FDA 510(k) Approved for the Urocross Expander System, a Non-Permanent Retrievable Implant for Treating Benign Prostatic Hyperplasia
Prodeon Medical received FDA 510(k) clearance for its Urocross Expander System, a non‑permanent, retrievable implant designed to treat lower urinary tract symptoms caused by benign prostatic hyperplasia. Clinical data from the Expander‑2 randomized trial showed a 48.1% mean improvement in...
FDA Town Hall: FDA’s Quality Management System Regulation (QMSR) – Medical Device Risk-Based Inspections
The FDA announced a town hall to discuss its updated Quality Management System Regulation (QMSR) that will govern medical device inspections beginning February 2, 2026. The new inspection framework replaces the long‑standing Quality System Inspection Technique (QSIT) and supersedes older...
FDA Issues Final Guidance on Medical Devices with Indications Associated with Weight Loss
The U.S. Food and Drug Administration issued final guidance titled “Medical Devices with Indications Associated with Weight Loss – Premarket Considerations.” The document outlines recommended non‑clinical testing and clinical study designs for devices aimed at weight loss, obesity treatment, or...
The 510(k) Pathway in 2026: Navigating a Shifting Regulatory and Political Landscape for Medical Devices
The 510(k) premarket notification pathway continues to dominate U.S. medical device approvals, but recent data show escalating safety failures and a persistent “predicate creep” problem. In Q1 2026 the FDA introduced electronic eSTAR submissions and issued draft guidance on predicate selection,...
Catalyst OrthoScience Gets FDA 510(k) Clearance of Archer® Patient-Specific Instrumentation for Shoulder Arthroplasty
Catalyst OrthoScience announced FDA 510(k) clearance for its Archer® Patient‑Specific Instrumentation (PSI), a suite of humeral and glenoid guides designed to translate 3D pre‑operative plans into the operating room. The system pairs with Archer® 3D Planning Software, supporting both anatomic...
Decision Criteria for Technology Commercialization of Medical Devices in 2026
The article updates the classic six‑factor framework for medical‑device commercialization, highlighting that Technological Feasibility, Market Size, and Reimbursement Potential remain top‑ranked but now demand AI integration, digital‑health ecosystem compatibility, and early payer engagement. Regulatory pathways have shifted dramatically with the...
Continuous Cardiac Monitoring: Redefining the “End” Of a Clinical Study?
Continuous cardiac monitoring via wearable ECG devices is reshaping clinical trials and post‑market care. Recent studies show that 14‑day monitoring after cardiac surgery uncovered atrial fibrillation in 24% of patients, many of which were missed until three‑month follow‑ups. In epilepsy...
Mastering MedTech Intelligence: The Intelligent Product Lifecycle at Fresenius Medical Care
Fresenius Medical Care has adopted PTC’s digital‑thread platform to create an intelligent product lifecycle that unifies design, quality and manufacturing data. The solution builds a shared product data foundation, enhancing traceability of requirements, design changes, and compliance documentation across cross‑functional...