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.
Testing
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...
What Caused Magellan’s Lead Test Problem? FDA is Stumped
FDA has not been able to identify the root cause of Magellan's inaccurate lead test results, and the recall has been expanded to include two additional testing systems. Amanda Pedersen FDA is conducting studies with the CDC to identify the cause of Magellan's faulty blood-based lead...
Harmful Chemicals in Spine Implants Prompt Zimmer Recall
Zimmer Biomet recalled two implantable spinal fusion stimulators after a routine cytotoxicity test indicated high levels of chemicals that could be toxic to tissues or organs. Amanda Pedersen Zimmer Biomet is recalling its SpF PLUS-Mini and SpF XL llb implantable spinal fusion stimulators...
The Zen of Anytime Audit Readiness
You know an FDA audit can happen at any time, but would you really be prepared if it happened today?
New Expectations for Biocompatibility Testing: Are You Ready?
Are you aware of the regulatory changes and testing advances involving biocompatibility? Image of an in vitro irritation test courtesy Nelson Laboratories. Biocompatibility testing requirements for medical devices are changing. "A lot of things are happening, on all fronts," Thor Rollins...