Testing

Is Your Testing Program Ready for the EU MDRs?

The new EU regulations will require much more documentation and perhaps some new evaluations from medical device manufacturers. An expert explains how to perform a gap analysis and begin preparing now for May 2020.

Another Reason to Update Your Biocompatibility Approach: EU MDRs

A chemist and biocompatibility expert offers the latest insights and predictions on medtech biocompatibility testing.

SyncThink Goes for Magic Leap to Get into AR

The Palo Alto, CA-based company will collaborate with Magic Leap, a specialist in augmented reality and spatial computer technology to bring its technology to an AR platform.

ArcherDx Seeking Broader Reach for Cancer Diagnostic

The Boulder, CO-based company has been granted a Breakthrough Device Designation for its liquid biopsy and tissue specimen assay.

New Study Finds Discrepancies in Cervical Cancer Screening Rates

A study from Mayo Clinic researchers shows less than two thirds of women ages 30 to 65 were up-to-date with cervical cancer screenings in 2016, which is below the 81% screening compliance rate self-reported in the 2015 National Health Interview Survey.

Veracyte Finds Ally in J&J for Early Lung Cancer Detection

The two companies will look at advancing the development and commercialization of diagnostic tests for early detection of the disease.

Consider the Most Probable Number Method for Bioburden Testing

The MPN method can be useful when traditional bioburden tests won’t work, but it must be clearly understood and carefully implemented.

7 Key Events That Solidified the Liquid Biopsy Market

Seven key trends and events helped make Liquid Biopsy attractive to investors, shareholders, patients, and physicians.

Supplier Stories for the Week of August 5

Here’s what was new in the world of medical device suppliers during the week of August 5.

MDxHealth’s Liquid Biopsy Test Proven to Be Cost-Effective

Researchers found that SelectMDx, a test for prostate cancer, had a cost-savings of $1,694 per patient.

FDA Gets Cancer Test on the Fast Track

Personal Genome Diagnostics received a breakthrough device designation from FDA for the PGDx elio plasma resolve liquid biopsy test.

Lots of Light in the Biophotonics Tunnel

Could recent discoveries in physics advance clinical testing?

Supplier Stories for the Week of July 1

Here’s what was new in the world of medical device suppliers during the week of July 1.

Better Imaging for Prostate Cancer Patients?

Blue Earth Diagnostics shines at the 2018 annual meeting of the Society of Nuclear Medicine and Molecular Imaging, with fleshed out results from the LOCATE trial.