MedTech leaders must find a balance between the slow, careful world of medicine and the fast-paced expectations of investors. Real success comes from choosing high-quality science over quick shortcuts, as being thorough is the only way to build lasting trust and reach the market.
The post The Structural Tension at the Heart of MedTech appeared first on MedTech Intelligence.
Protect patient data with medical IoT security. Learn how AI, Zero Trust, and encryption can prevent cyber threats and secure healthcare IoT devices.
The post Cybersecurity Tactics for Medical IoT Devices appeared first on MedTech Intelligence.
Many challenges of designing and validating pediatric digital health devices are over-looked across developmental stages. Regulatory strategy, human factors, software architecture, and algorithm performance are critical consideration in dynamic patient populations.
The post From Toddlers to Teens: The Hidden Complexities of Bringing Pediatric Wearables to Market appeared first on MedTech Intelligence.
A long-overdue push to reduce administrative friction, improve access to patient data, and move the system away from workflows that continue to waste time for both patients and providers.
The post Interoperability was Never the Finish Line in Healthcare appeared first on MedTech Intelligence.
New pathway cuts red tape and brings predictability to Medicare coverage for Breakthrough Devices.
The post CMS, FDA Announce RAPID Coverage Pathway to Accelerate Device Reimbursement appeared first on MedTech Intelligence.
Having already set expectations around the structured capture of medical device safety data, regulators are now ready to analyze related insights, and they expect device manufacturers to match this capability.
The post Beyond Reporting: Realizing Continuous Safety Surveillance for Medical Devices appeared first on MedTech Intelligence.
As generative AI becomes embedded in clinical research, concerns around hallucinated citations and unverified outputs are growing. These inaccuracies are already entering scientific literature, raising questions about reliability, compliance, and patient safety. Addressing this challenge requires more evidence-grounded AI and disciplined implementation.
The post Safeguarding Scientific Publishing from AI Hallucinations and Fabricated Citations appeared first on MedTech Intelligence.
Stryker signs definitive agreement to acquire Amplitude Vascular Systems to add next-generation IVL technology to peripheral vascular portfolio
The post Styker Adds IVL Technology to Peripheral Vascular Portfolio with Amplitude Acquisition appeared first on MedTech Intelligence.
Traditionally, contract negotiation has been viewed as a financial or legal responsibility, typically led by finance teams, legal counsel, or executive leadership, with operations stepping in afterward to execute against decisions that have already been made, but that model is evolving as healthcare delivery becomes more interconnected and operationally complex, requiring administrators to engage earlier in the process, not only to understand what is being agreed to but to help define how those agreements will function in real-world environments.
The post The Healthccare Burnout Backlask (pt 4): Why Contract Negotiation Has Become a Core Strategic Skill for Healthcare Administrators appeared first on MedTech Intelligence.
Companies and researchers often fail to disclose negative trial results, resulting in significant gaps in the public record and a publication bias that obscures the true landscape of drug development outcomes—overrepresenting successes and underrepresenting failures. This gap can also create a distorted perception of the safety and efficacy of medical products.
The post FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results appeared first on MedTech Intelligence.
As organizations introduce additional technologies, including AI-enabled tools and CRM platforms, these gaps become more pronounced. Those that are seeing meaningful improvements are taking an end-to-end view, evaluating how systems interact within a unified workflow and ensuring that data flows seamlessly and actions are triggered in a coordinated manner, thereby reducing the need for manual intervention and follow-up.
The post The Healthcare Burnout Backlash (pt 3): How Workflow Redesign Is Helping Healthcare Organizations Offset Staffing Shortages appeared first on MedTech Intelligence.
Designed to expand treatment options for patients with cirrhosis and complications of portal hypertension, this next‑generation, adjustable‑diameter device represents the latest advancement by BD in interventional therapies addressing complex liver disease, according to the company.
The post BD Announced Application of CE Mark for the Liverty TIPS Stent Graft appeared first on MedTech Intelligence.
Hologic announced the appointment of José (Joe) E. Almeida as Chief Executive Officer, effective immediately upon closing of the previously announced company acquisition.
The post Blackstone and TPG Complete Acquisition of Hologic; Names New CEO appeared first on MedTech Intelligence.
The FDA has approved the NEXUS Aortic Arch Stent Graft enabling commercial launch of the NEXUS System in the US.
The post Endospan Receives FDA Approval for the NEXUS Aortic Arch Stent Graft System appeared first on MedTech Intelligence.
The InVera Infusion Device is approved for use in the US and EU within its indications.
The post InVera Medical Receives FDA Clearance for Non-Thermal Chronic Venous Disease Device appeared first on MedTech Intelligence.
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.
Innovation, implementation & utilization of medical technology
