Why Flex is betting on stretchtronics for medtech

The wearable lab at Flex (formerly Flextronics) reports it’s making strides when it comes to creating devices that are transparent and seamless. “Usually when you think about healthcare, you picture a person in a bed with wires running all around. We think healthcare should be as easy as putting on a T-shirt,” said Flex CEO John

Edwards Lifesciences has ‘key events’ around TAVR this week

Edwards Lifesciences is planning some important TAVR reveals during the PCR London Valves 2017 course that is underway. The Irvine, Calif.–based cardio devices company said yesterday that it plans to introduce the new Sapien 3 Ultra valve during the event, which runs until tomorrow. Edwards officials expect the Sapien 3 Ultra to receive CE Mark

Theraclion makes strides with echotherapy in Germany, Hong Kong

Theraclion (Malakoff, France) today announced wins when it comes to use of its echotherapy treatment in Germany and Hong Kong. The Heilfürsorge Bundespolizei (medical insurance of the federal German police force) now covers echotherapy for both breast fibroadenomas and thyroid nodules. “It is a strong mark of recognition for our technology that the German federal police

EY, Evaluate are upbeat about the medical device industry: Here’s why

The medical device industry is growing at a healthy and steady pace, according to new reports that EY and Evaluate released today during AdvaMed’s annual Medtech Conference. “The results of this year’s report is a direct contrast to last year and tells a positive story about the future of the medtech industry,” said EY partner

This Dräger newborn incubator focuses on ‘intact survival’

The latest in incubator technology from Dräger focuses on long-term health and quality of life, as well as survival. One device paying particular attention to these trends is the Babyleo TN500 IncuWarmer beds from Dräger. Florida Hospital announced it’s the first in the United States to implement the Babyleo beds. The beds are being used in

FDA clarifies if microneedling should be classified as a medical device

By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have published new guidance clarifying how they determine if microneedling products used for skin treatments qualify as medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only

Brentwood buys Mexico cleanroom facility

Brentwood Industries (Reading, Pa.) has expanded its manufacturing capabilities by purchasing a cleanroom facility in Tijuana, Mexico. It plans to open the facility in early 2018. This new purchase is the second facility of Brentwood’s that is dedicated to customers thermoformed medical packaging. “We’ve been evaluating expansion into Tijuana for a number of years, particularly considering

Hurricane Maria poses threat to med device hub in Puerto Rico

Hurricane Maria is posing a threat to medical device and pharmaceutical manufacturing plants in Puerto Rico, according to a new Bloomberg report. The island is home to facilities for Johnson & Johnson (NYSE:JNJ), Pfizer (NYSE:PFE), Amgen (NSDQ:AMGN), Merck, Medtronic (NYSE:MDT) , Abbott (NYSE:ABT), Stryker (NYSE:SYK) and dozens of others, according to the report. Most of the companies created facilities in Puerto Rico due to tax incentives, Bloomberg reports.

Medtech complaint handling: Is there something to complain about?

Medtech complaint handling appears to be a work in process, according to Sparta Systems’s recent quality management market survey. The 2017 survey – which had 148 respondents in highly regulated industries including medical devices (23%) – found that nearly a quarter of those who answered did not have a well-defined and adopted complaint handling process. Only

How Boston Scientific is boosting medical device value

Boston Scientific over the summer unveiled a new value-add for its implantable cardio devices: an online Trugevity calculator that lets physicians predict battery life. The idea is to help health providers quickly grasp the benefits of Boston Sci’s longer lasting EnduraLife battery technology, which the company touts has nine clinical studies and eight years of real-world

NIH awards $15M for 3D human tissue models

The National Institutes of Health has announced 13 two-year awards, totaling $15 million a year, for hospitals and universities to develop 3D human tissue models. The funding will go toward the first phase of a five-year program. Even though pre-clinical studies using cell and animal research models are promising, more than 60% of investigational drugs

Smiths Medical could have a cybersecurity problem

The US Dept. of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team has released a warning over issues with Smiths Medical’s Medfusion 4000 wireless syringe infusion pump after discovering 8 cybersecurity vulnerabilities in the device. The notice is for versions 1.1, 1.5 and 1.6 Medfusion 4000 wireless syringe infusion pumps, according to the DHS […]

IBM and MIT partner on AI research lab

IBM and the Mass. Institute of Technology plan to expand their ongoing partnership to create the MIT-IBM Watson AI Lab to perform research on artificial intelligence. IBM is making a 10-year, $240 million investment to establish the Cambridge, Mass. center. The lab will harness the work of 100 scientists, professors and students to develop AI…

RightEye raises $7.3 million from VSP Global, angel investors

Eyecare company VSP Global said today that it has made an investment in RightEye and its game-based vision tests. VSP (Rancho Cordova, Calif.) did not disclose the amount it provided RightEye (Bethesda, Md.) in the Series A round. But an SEC Form D that RightEye filed in June shows a roughly $7.3 million money-raise, which a spokesperson for

Dulas solar-powered refrigerators save vaccines in Myanmar

Dulas, a British solar refrigeration manufacturer, has completed a training program in Myanmar for Ministry of Health technicians as part of its supply package of its World Health Organization accredited VC200 Solar Direct Drive (SDD) vaccine refrigerators. The program was designed to help healthcare workers learn about the technology of the refrigerators to make sure