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CardioFocus Finishes up Enrollment for HeartLight X3 Trial

The Marlborough, MA-based company said it could pick up a CE mark for the endoscopic ablation system sometime in mid-2019.

Medtech Company of the Year 2018 Finalists

These companies have risen above the rest in 2018. Which one do you think deserves to wear the crown?

Investigators on the Path to Alzheimer’s Detection Test

A team from Brigham and Women’s Hospital are developing a test that can detect tau protein, a calling card for Alzheimer’s disease.

Supplier Stories for the Week of December 2

Here’s what was new in the world of medical device suppliers during the week of December 2.

Could AI Become the New Quality Control Manager in Medical Device Manufacturing?

By applying predictive analytics, medical device companies can make a shift to a proactive mode to avoid potential problems before they happen, according to an expert in business strategy and software engineering.

Tiny Wearable Device Warns of Exposure to UV Light

The technology was designed by Northwestern Medicine along with Northwestern’s McCormick School of Engineering scientists and has the potential to monitor, separately and accurately, UVB and UVA exposure for people at high risk for melanoma.

Past Covidien, ev3 Activities are Costing Medtronic a Hefty Sum

Medtronic agreed to pay a total of $50.9 million to resolve three separate claims against Covidien and ev3, both of which are now part of Medtronic.

GRAIL’s SUMMIT Will Help Define its Liquid Biopsy Path

The Menlo Park, CA-based company’s 50,000-patient trial will launch in 2019 and could be one of the most significant events of the year for the liquid biopsy market.

FDA Wants to Change the De Novo Pathway

FDA proposed a new rule that, if finalized, could motivate more companies to choose the de novo pathway for new devices that do not have a modern predicate.

Are Smaller Hip Implants in Older Patients More Cost Effective?

University of Bristol Medical School Researchers led a study that shows cemented metal-on-plastic hip replacements less than 36 mm in diameter are the most cost-effective in patients older than 65.

Is 2019 Going to Be a Standout Year for TAVR?

JenaValve has received a nod from FDA to expand enrollment in an IDE of its TAVR system. The measure comes at a time when the TAVR landscape is expected to shift.

Pushing 3D Printing Forward

A group at the University of Minnesota is 3D printing patient-specific organ models, sensors, and neural regeneration devices.

What Can Medtech Expect with the New Congress?

Oversight of industry could change, just as it has in the past.

Diabeloop Is 2nd to Win CE Mark for Artificial Pancreas System

The small startup will now be able to compete against Medtronic’s MiniMed 670g, but there are other technologies still in development that could have an even greater impact on the market.