NEW PRODUCT DEVELOPMENT

New Product Development: FDA Issues Final Guidance on IVD Oncology Trials

On Oct. 10, 2019, the FDA finalized guidance on an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic (IVD) in an oncology clinical trial is … [Read more...]

Global News: EU Delays Launch of Eudamed Database

The European Commission (EC) is delaying the launch of the European database on Medical devices (aka Eudamed) until May 2022.  Originally, manufacturers were supposed to be compliant by May 2020 with … [Read more...]

Industry News

Kellison and G2 Intelligence Honor Dr. Sidney Goldblatt

Dr. Sidney Goldblatt, MD, is the 2019 recipient of the Kellison Public Service Award. Dr. Goldblatt has been founder, medical director and CEO of Molecular Dx; founder and CEO of Goldblatt Systems; … [Read more...]

INNOVATION

Point of Care: Handheld Device Shows Promise in Detecting Concussion from Blood Samples

A handheld portable device could be more effective than a CT scan in detecting mild traumatic brain injuries (TBI), according to a new study published in The Lancet Neurology. Because it is capable of … [Read more...]

SAFETY

Business Trends: Commercial Testing Companies ‘Sell’ Health Screenings

Several companies market an array of preventive tests directly to consumers. Are these companies and tests legit? What does the medical community have to say about such companies and advertising … [Read more...]

INDUSTRY BUZZ

Google This: Labs Partner with Tech Giant

In recent months, several diagnostic companies have announced alliances with Google, and all involve Google Cloud Platform. Here is how four companies are using Google's … [Read more...]

FOCUS ON

Surviving PAMA: Keep an Eye on Industry Disruptors

A talking point of a G2 Lab Institute 2018 presentation deserves closer attention, especially given its implications for the lab industry. "Advantages and Disadvantages Confronting Labs in a … [Read more...]

INNOVATION

Multi-Cancer Screening Tests Are Getting Closer to Reality

The hope of developing a single blood test capable of detecting multiple types of early-stage cancer is getting closer to becoming a reality. Two hopeful players, GRAIL (Menlo Park, Calif.) and Thrive … [Read more...]

INNOVATION

Rapid, Genomic-Based Surveillance IDs Aids Hospital Infection Control

Routine genomic sequencing can identify and inform hospital infection control personnel of patient transmission events in near real-time, enhancing not only detection, but follow-up and investigation … [Read more...]

NEWS

DNA Testing at the Border

The Department of Homeland Security (DHS) is piloting a DNA testing program at the U.S.-Mexico border. The program aims to establish "DNA-based family relationship (kinship) verification to improve … [Read more...]


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