Leaders in medtech and cloud computing discuss payoffs and potential in device connectivity, product development and cross-industry partnerships. If knowledge is power, that power comes from a steady stream of information, and we know there’s no shortage of that in healthcare. The challenge has long been how to capture that information, store it, analyze it […]
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Manufacturing matchmaker Fictiv raises $100M for supply chain push
Fictiv has closed a $100 million Series E funding round, the on-demand manufacturing technology company said today. Fictiv focuses on “helping companies produce better products,” co-founder and CEO Dave Evans said, with three main offerings: new product development, engineer-to-order products, and maintenance, repair and operations (MRO). But the company doesn’t actually own any manufacturing equipment. […]
Fresenius Medical Care hires replacement for longtime CEO
Fresenius Medical Care (NYSE: FMS) has hired Carla Kriwet as its next CEO, effective Jan. 1, 2023. Kriwet will replace Rice Powell, who will step down on Dec. 31 after hitting the company’s age limit. Powell is 66. Kriwet is 51. “I fully identify with the vision of making the lives of the patients who […]
Medtech CEOs sound off on semiconductor shortage, pushing Biden administration for prioritization
AdvaMed continues to push the Biden administration to prioritize medical device manufacturers for semiconductor supplies. With medtech companies still struggling to source chips amid a global shortage, the industry association held a meeting this week with some of its members and Secretary of Commerce Gina Raimondo to make their case. “Semiconductor chips are crucial to […]
Johnson & Johnson shareholders approve racial justice audit proposal
Johnson & Johnson (NYSE: JNJ) investors voted in support of a proposal for a third-party racial justice audit at the annual shareholder meeting. It was the only shareholder proposal to pass at yesterday’s annual meeting, where investors also considered proposals to discontinue global sales of baby powder containing talc, to study the public health costs of protecting […]
Medtronic investigates HVAD pump welds after patient deaths
Medtronic (NYSE:MDT) is investigating a new problem with its HeartWare Ventricular Assist Device (HVAD) nearly one year after halting sales and new implantations of the device. Fridley, Minnesota-based Medtronic said it received three complaints of suspected pump thrombosis in patients. Two of the patients died after their heart pumps were exchanged. Medtronic found a malfunction when inspecting […]
Integer misses on Q1, adjusts full-year outlook
Holdings (NYSE:ITGR) posted first-quarter results today that fell short of the consensus forecast on Wall Street and adjusted its outlook for the rest of the year to include its recent acquisition of Aran Biomedical. The Plano, Texas–based medical device contract manufacturing giant reported profits of $11 million, or $0.34 per diluted share, on sales of $311 […]
Moderna seeks authorization for COVID-19 vaccine in children as young as 6 months old
While a portion of the public is now eligible to receive a second booster dose of COVID-19 vaccine, the FDA has not yet authorized a vaccine for children aged 6 months to 5 years old. Moderna (Nasdaq:MRNA) is vying to be the first. The company announced today that it is filing a request for emergency […]
Ear-puffing device for migraine treatment wins FDA breakthrough designation
A handheld device that treats migraine attacks with puffs of air in a patient’s ears has been designated a breakthrough device by the FDA. Tempe, Arizona-based Nocira said it is the first company to announce breakthrough device designation for treating migraine attacks in both chronic and non-chronic migraine patients ages 18 and up. The device […]
Hologic handily beats the Street with Q2 results
Hologic (Nasdaq:HOLX) posted second-quarter results today that solidly exceeded the consensus forecast on Wall Street and increased its outlook for the rest of the year. Marlborough, Massachusetts–based Hologic reported profits of $455.7 million, or $1.80 per diluted share, on sales of $1.436 billion for the three months ended March 26, 2022. That was a bottom-line […]
Pfizer and BioNTech file for EUA for COVID-19 vaccine booster in kids 5 to 11
Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application with the FDA for emergency use authorization (EUA) for a 10-µg booster dose of their BNT162b2 COVID-19 vaccine in children aged 5 to 11. The companies included data in the application from a Phase 2/3 study that tested a booster dose in children between […]