From complexity to clarity: Making sense of mosaic variants and preliminary evidence genes

Biocompatibility evaluation of implantable medical devices

In the biocompatibility evaluation of medical devices according to ISO 10993-1, implantable devices are generally considered a subset of devices that fall into prolonged and long-term exposure duration categories. These implantable devices come in many forms and clinical uses, such as in bone putties, stents, wound dressings and sutures. While the ISO 10993 series of standards prescribe the methods and risk assessments required to evaluate the safety of a medical device, the approach and overall risk to be assessed varies greatly from device to device. While ISO 10993-1 coupled with certain vertical standards (e.g., ISO 11979 and ISO 7405) and region-specific regulatory guidance have set forth the totality of requirements, this paper will focus on the approaches of ISO 10993-1 and other generally accepted principles to be horizontally applied broadly.

Determination of patient contact duration for medical device classification: Impact for repeat-use devices

Medical device development should include risk-based considerations that evaluate product functionality, efficacy and safety. From prototype design to final device submission, development strategy should lie at the intersection of engineering principles, biological safety and regulatory pathway. The biocompatibility testing and regulatory scrutiny on a medical device is highly dependent on its intended use in clinical application. Medical devices are classified in the biocompatibility testing matrix based on patient contact and patient contact duration.

Six ways to support women's health

From getting exercise to eating well, learn six practical ways to improve women's health.

Delivering precision in a critical bone defect model for implantable device safety testing

When serious bone injuries occur, patients often need treatments that can stimulate new bone growth. Biotech companies that develop medical devices for this purpose rely on critical bone defect models to assess the effectiveness of the new product. Recently, an emerging biotech developed a bone void filler that warranted safety testing to see how well their implantable device could promote bone regeneration. Seeking a lab partner that could perform the necessary study and show new bone growth via a complicated surgical model, the sponsor turned to Labcorp for support.

Beyond traditional immunoassay: LC-MS for antibody isotyping and quantitation

Lab data as the missing link for more effective chronic disease management; a value-based care approach

Discover strategies and benefits of using lab data to drive gaps-in-care strategies in chronic disease management and enhance value-based care success.

Importance of extraction vessel shape in medical device testing: A GeneTox case report

A 4-week study of a mouse multiple sclerosis (MS) model capturing the pathophysiology of autoimmunity and neuroinflammation

Optimal volume and dose of AAV9-mCherry in stereotaxic targeting of putamen in C57BL/6 mice