Precipio merged with Transgenomics last year to expand its liquid biopsy prowess.
Myriad Genetics presented results from a 24-week study that showed Major Depressive Disorder patients were 50% more likely to achieve remission and 30% more likely to respond to treatment using the GeneSight Psychotropic genetic test.
Orion Diagnostica develops Point-of-Care tests and earned about $67 million in sales for its most recent reported year.
Qiagen has developed liquid biopsy panels for prostate and lung cancer and is set to introduce the products at the American Association for Cancer Research annual meeting this week.
Jan Medical partners with U.S. Army to nab a concussion detection indication for BrainPulse technology.
Biocompatibility of medical devices is a complex and evolving subject. Here's what you need to know.
Mechanical and chemical testing are needed to bring complex drug-delivery products and other combination products to market.
Linking the experimental process to the design controls defined by FDA can help ensure an effective and efficient new product development effort, as well as a competitive market advantage.
When it comes to verification and validation, medical device companies need to ensure that what they're doing actually makes sense.
FDA said 155 devices on the U.S. market are included in a recall of Penumbra's 3D Revascularization device because the delivery wire could break or separate during use. Amanda Pedersen Penumbra initiated a voluntary recall of its Penumbra 3D Revascularization device because of a risk...
Meridian Bioscience's diagnostics unit knew about its faulty blood lead test results for almost three years before FDA caught wind of the problem, the agency noted in its inspection report. Amanda Pedersen At best, Magellan Diagnostics ignored customer concerns about its faulty blood lead...
*/ FDA issued a safety warning regarding possible navigational accuracy errors linked to frameless stereotaxic navigation systems, although the agency said the overall benefits of using these systems continue to outweigh the risks. Amanda Pedersen Certain types of stereotaxic navigation...