Health technology developers need to prioritize security from the moment a device or platform is first incepted.
Class I device manufacturers need to keep on top of new classification rules to avoid loss of market share under the close approaching EU MDR deadline.
After prompting from the agency, Allergan issued a worldwide recall of its BIOCELL textured breast implants and tissue expanders.
A timely step toward ensuring patient safety through data-driven product development.
A product malfunction could cause potential over-infusion or unintended delivery of medication.
After a series of delays and false starts, EMA is now progressing its ISO IDMP agenda with firm intent. The first implementation guide is out now for consultation, to be followed by a second actionable version by next year. Life sciences companies targeting Europe will have a year to comply with all the measures—but this will be a lot of work.
The G4 gives doctors an additional range of clip sizes, along with enabling real-time procedure assessment.
The agency is encouraging the industry to develop sterilization approaches that either don’t rely on ethylene oxide or reduce emissions from this method.
The agency is recommending that patients replace their affected pumps with models that can better protect against the risks.
By simplifying labeling compliance, companies can focus on better serving current and new markets.