Advancing the Biopsy: Biosensors as a More Accurate and Sensitive Disease State Diagnostic Tool
Physicians need technology that helps them track disease progression and response to therapy.
Tag Archives: patient safety
ECRI Warns 70% of KN95 Masks from China Don’t Meet Standards, Puts Healthcare Workers at Risk
The non-profit organization states that 60–70% of KN95 masks tested do not filter 95% of aerosol particulates.
Asia 2020 Device Regulatory Update
Across Asia, government health and safety authorities have tightened regulations on medical devices this year, as markets continue to experience rapid change, and as the devices themselves gain sophistication and complexity at a blistering pace.
Liability Risks and Litigation Defenses for COVID-19 Tests: Potential Claims and Defenses
Part one of this series looks at the claims brought against manufacturers of diagnostic test kits.
Post-COVID Era of Product Safety: Recall Risks During and After a Pandemic
The medical device industry is pressured to aid those stricken by the pandemic, while at the same time working to mitigate increased risks usually associated with hurried manufacturing and quality control procedures.
What Patients Expect Out of Their Wearable Medical Devices
User needs and expectations continue to advance. Medical device technology needs to keep pace. For a successful design, take the following requirements into consideration.
Playing by the Rules: A Lever for Doing Better Business?
Investments in new processes and systems must satisfy the needs of the authorities and ensure patient safety and public confidence. Getting it right is likely to be expensive. but regulatory compliance shouldn’t be viewed purely as a cost center.
Medical Device Cybersecurity in the Age of IoMT
As the proliferation of connected and complex medical devices grows, healthcare providers are more susceptible to cyberattacks.
Postmarket Surveillance: The Urgent Need for a Holistic Approach
Simplifying the PMS process globally from end to end, can help medtech companies realize significant improvements across the board while keeping operating costs under control.
FDA Clears Abbott’s Continuous Glucose Monitoring System for Use in Children
The FreeStyle Libre 2 now has indications for children ages four and older.
