Monitoring is Key in Precipio’s Liquid Biopsy Success
Precipio merged with Transgenomics last year to expand its liquid biopsy prowess.
Testing
Supplier Stories for the Week of May 6
Here’s what was new in the world of medical device suppliers during the week of May 6.
GeneSight Weeds Out Ineffective Drug Therapies for Depression
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.
Supplier Stories for the Week of April 22
Here’s what was new in the world of medical device suppliers during the week of April 22.
Orion Sheds Diagnostic Unit for $200M Plus Milestones
Orion Diagnostica develops Point-of-Care tests and earned about $67 million in sales for its most recent reported year.
Qiagen To Unveil 2 Liquid Biopsy Tests at AACR
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.
Concussion Detection Still A Hot Market for Medtech
Jan Medical partners with U.S. Army to nab a concussion detection indication for BrainPulse technology.
A Brief Introduction to Medical Device Biocompatibility
Biocompatibility of medical devices is a complex and evolving subject. Here's what you need to know.
What Medical Device Manufacturers Need to Know about FDA’s Predictive Toxicology Roadmap
Toxicologists offer their perspectives on the future of testing.
Biocompatibility Testing: Are You Considering Interactions Between Packaging and Devices?
MD&M Minneapolis speakers point out potential sources of extractables and leachables to consider.
DDL Expands Testing Portfolio to Support Combination Products
Mechanical and chemical testing are needed to bring complex drug-delivery products and other combination products to market.
Avoid the Consequences of an Experiment Gone Wrong
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.
Design Verification vs. Design Validation: Right Questions or Right Answers?
When it comes to verification and validation, medical device companies need to ensure that what they're doing actually makes sense.
Risk of Wire Breakage Prompts Penumbra Recall
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...
Did Magellan Try to Hide its Quality Control Problems?
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...
Some Surgical Nav Systems are Error-Prone, FDA Warns
*/ 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...