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The FDA has released safety reviews of four materials commonly used in implantable medical devices and the effects of the materials on patients over time. Read More
Each of MedCAD’s AccuPlate Patient-Specific Plates are designed based on the patient's scanned anatomical data in consultation with MedCAD and the surgeon, and milled out of pure, implant-grade titanium. Read More
Medical device software can be vulnerable to cyber threats, “especially if the device is older and was not built with cybersecurity in mind,” the agency has said. Read More
The FDA said it was proposing to refuse Intarcia Therapeutics’ drug-device combination product, ITCA 650, for continuous release of the type II diabetes drug exanatide. Read More
Abbott Laboratories’ CardioMEMS implantable heart failure monitor missed the primary endpoint in an expanded patient population, but the company said that COVID-19 may have skewed the results. Read More
The FDA is getting back its rulemaking authority, which was significantly weakened under President Trump, as the Biden administration reverses multiple policies from the previous administration. Read More
The FDA issued an update on which types of devices may be offered as over the counter (OTC) devices and what devicemakers should consider when making the switch from prescription to OTC status. Read More
Changing a 510(k)-cleared device labeled for prescription use only to a device labeled for OTC use would likely require a new premarket submission, the FDA said. Read More
Australia’s Therapeutic Good Administration has begun a postmarket review of all continuous and non-continuous ventilators, acute care ventilators, ambulatory ventilators including positive airway pressure (CPAP) devices and bi-level positive airway pressure (BiPAP) devices on the Australian Register of Therapeutic Goods (ARTG). Read More
Australia’s Therapeutic Goods Administration (TGA) has released updated guidance on new regulations for software-based medical devices that became effective in February 2021. Read More