St. Jude Medical Must Pay $27 Million in Settlement Involving Intentional Sale of Defective Heart Devices
The government alleges that the company did not disclose serious health events in certain implantable defibrillators.
Tag Archives: Focus Article – Homepage
Automated Software Validation: Fast-Tracking MES Implementations in Regulated Environments
Automating validation processes gives manufacturers the flexibility and capability to make changes, updates and re-validation, making it easier to upgrade or add new MES modules to their process. Simplifying the process through automation leads to faster ROI and time to market.
Telehealth Goes Mainstream: The Doctor Will Virtually See You Now
COVID-19 ushered in a fundamental change in how medicine is being delivered.
Effective Manufacturing Test Strategies to Improve the Quality of Connected Medical Devices
Adding wireless connectivity to medical devices brings convenience to patients, and can facilitate more effective healthcare delivery and lower healthcare costs. Its success depends on the ability of manufacturers to produce reliable, connected products that do not fail prematurely in the field.
AdvaMed Asks Biden Administration to Make Transport of Medical Supplies a Top Priority
Recent transportation challenges have affected the medtech industry’s ability to deliver healthcare products.
Next-Generation Digital Twins in Healthcare
Digital twins have the capability to enable safer medical devices and improve overall patient outcomes.
Healthcare IT Solutions Expand with Rapid Digitalization Trend
Electronic health records and mHealth solutions are two of the leading development areas in the medical domain, augmenting opportunities for the healthcare IT industry.
How Rethinking Lean Will Strengthen Medical Device Manufacturing
Medical device manufacturers can accelerate their digital transformation priorities through lean practices to better manage supply chain risk, complexity and disruptions.
Remote Audits and Other New Ways of Working in a Post-COVID MedTech World
Audits for medical device companies and other organizations in the medtech space used to be primarily in person. However, the pandemic magnified flaws in the global regulatory process. A shift to remote audits may be the key to interorganizational and international regulatory harmonization moving forward.
Medtronic Halts Sale of HVAD System, Urges Healthcare Providers to Stop Implantation
FDA also supports the removal of the HeartWare HVAD System from the market.
