Siemens Healthineers has let go of 67 workers at a diagnostics facility in Flanders, New Jersey, according to a notice filed with the state Department of Labor & Workforce Development. The WARN notice from Siemens Healthcare Diagnostics, which the state received on June 8, said the layoff goes into effect on September 7. It cited […]
The top IVD innovation news stories of 2023 — so far
This year is proving to be another important year for innovation in the in vitro diagnostic (IVD) space. According to the FDA, IVD devices are tests performed on samples taken from the human body. They could be everything from blood tests processed in labs to home COVID-19 or pregnancy tests to continuous glucose monitors using […]
Illumina’s CEO resigns, MacMillan expresses confidence
Illumina Inc. (NASDAQ: ILMN) announced that CEO Francis deSouza has resigned from the DNA sequencing and array-based tech developer. The news, announced yesterday, comes more than a week after Hologic CEO Stephen MacMillan became non-executive board chair. Edwards Lifesciences CFO Scott Ullem filled a second new seat, bringing the board seat total to 12. Illumina […]
LVADs save lives: So why aren’t more available?
Abbott says its HeartMate 3 LVAD is clinically proven to extend life by five years or more — but thousands of people in the U.S. still die of heart failure within a year. Kyree Miller, a 30-year-old college student, navigated seven long years of heart failure with the assistance of an Abbott HeartMate left ventricular […]
5 keys to Mike Mahoney and Boston Scientific’s success
Boston Scientific’s market capitalization has grown nearly 10 times larger since Mike Mahoney joined as CEO in 2011. He shared key insights about corporate strategy at DeviceTalks Boston in May. Boston Scientific is one of the bright spots as the medical device industry goes through a rough patch. It’s more expensive to run a business, […]
Hologic CEO MacMillan to chair Illumina’s board
Illumina (NASDAQ: ILMN) announced today that its board has elected Hologic CEO Stephen MacMillan to fill a new seat and become its non-executive chair. Edwards Lifesciences CFO Scott Ullem will fill a second new seat — bringing the number of board seats to 11 at the San Diego–based DNA sequencing and array-based tech developer. The […]
Bayer is making a big digital health play
Bayer announced that it has launched a business unit that will focus on precision digital health products across a range of everyday health categories. Bayer will prioritize developing digital solutions that enable people to make more informed health choices based on personal insights and novel delivery mechanisms, the company said in a news release posted […]
iRhythm has an FDA warning letter over Zio AT quality systems
iRhythm stock is down today on news of an FDA warning letter involving its Zio AT mobile cardiac telemetry device. In a Form 8-K filed with the SEC yesterday, iRhythm said it received the warning letter on May 25. The warning letter resulted from an FDA inspection at the company’s Cypress, California facility that concluded […]
Exactech announces global release of next-gen GPS Shoulder
Exactech will mark the global release of the latest version of its ExactechGPS shoulder surgery navigation software at the annual Shoulder Masters Course in Amsterdam later this week. The launch is taking place in EMEA and APAC countries. It follows the first surgery in the United Arab Emirates earlier this month, leveraging the company’s Active […]
FDA clears Think Surgical handheld robotic knee surgery device
Think Surgical announced today that it’s received FDA 510(k) clearance for its TMINI miniature robotic system that assists with total knee surgeries. Here’s how Fremont, California–based Think Surgical described the TMINI system in its news release: “The TMINI system includes a wireless robotic handpiece that assists surgeons in performing total knee replacement. Following a CT-based […]
A veteran Medtronic executive takes a new role at Baxter
Medtronic Cardiovascular Diagnostics and Services President Julie Brewer has left for a new position at Baxter. Brewer announced on LinkedIn near the end of last week that she has joined Baxter as President of the Patient Support Systems, Global Surgical Solutions and Care Communications team. “Baxter is a great company with a wonderful purpose of […]