Scopio Labs today announced FDA 510(k) clearance for its X100HT, which features a new slide loader that automatically prepares samples and feeds them into the digital blood scanner for AI-powered analysis. The Tel Aviv-based digital microscope developer said the technology eliminates the need for manual microscopic examination when reviewing white and red blood cells and […]
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Medtech startups land European Innovation Council Accelerator funding
European medtech startups were among the 74 companies receiving a combined €382 million in grants and investments, the 2022 European Innovation Council Accelerator said this week. Each company will be eligible for up to €17.5 million (about $18.8 million in U.S. currency) worth of grants and equity investments. Most of the funding will be available […]
FDA designates new Medtronic HVAD pump implant recall as Class I
Medtronic (NYSE:MDT) is recalling 1,614 of its HeartWare Ventricular Assist Device (HVAD) pump implant kits due to defective welds connected to at least one death. The Class I recall — the most serious type of FDA recall, in which use of the device may cause serious injuries or death — is the latest of more than 15 […]
BD to purchase pharmacy automation firm Parata Systems
BD (Becton, Dickinson and Company) (NYSE:BDX) has partnered with the private equity firm Frazier Healthcare Partners to acquire Parata Systems, a provider of pharmacy automation solutions. The purchase price of the acquisition is $1.525 billion. Founded in 2006, Parata Systems offers a range of products and services, including medication adherence packaging technology and perpetual inventory […]
Abbott imaging catheter recall flagged as Class I by FDA
The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall. That’s the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11. The […]
Zimmer Biomet adds ESG and CEO visibility to executive’s duties
Zimmer Biomet (NYSE:ZBH) today announced additional responsibilities for Investor Relations SVP and Chief Communications Officer Keri Mattox. Mattox’s new title at the Warsaw, Indiana-based orthopedics company is chief communications and administration officer. She will be responsible for “building and executing a comprehensive strategy around Environmental, Social and Governance (ESG) initiatives and increasing CEO visibility, engagement […]
‘Catastrophic explosion’ and resin shortage led Medtronic’s supply chain problems
Medtronic CEO Geoff Martha today said a “catastrophic explosion” in Medtronic’s supply chain for packaging and a shortage of resins were the biggest issues hurting the company’s fourth-quarter performance. Fridley, Minnesota-based Medtronic (NYSE:MDT) reported about $350 million less in sales than analysts were expecting for the quarter, which ended April 29. Martha said about 75% of […]
Device developer SeaStar Medical hires chief medical officer
SeaStar Medical has hired Dr. Kevin Chung as chief medical officer of the medtech developer starting July 1. Denver-based SeaStar is developing a platform therapy focused on hyperinflammation of vital organs. The company’s Selective Cytopheretic Device was designated as a breakthrough device by the FDA earlier this year. SeaStar is set to go public in the […]
Henry Schein investors push back on executive pay
Nearly half of Henry Schein (Nasdaq:HSIC) shareholders who voted at this month’s annual meeting voted against the company’s pay packages for top executives, according to a new SEC filing. About 48.5% of voting shareholders voted against the company’s executive pay plan in what’s known as the Say-on-Pay vote, according to vote results of the May 18 […]
Zimmer Biomet narrowly avoids shareholder rebuke on executive pay
An unusually large share of Zimmer Biomet (NYSE:ZBH) investors voted against the orthopedics company’s pay packages for top executives at the annual shareholder meeting. About 54 percent of voting shareholders supported the pay packages of the company’s five top-paid executives at the May 13 meeting, according to results filed with the SEC yesterday. In 2021, nearly 93 […]
Ambu replaces CEO with new leadership
Ambu today said it has hired board member Britt Meelby Jensen to replace CEO Juan Jose Gonzalez, effective tomorrow. “Since Juan Jose Gonzalez joined as CEO in 2019, Ambu has made good progress and achieved important milestones on the strategic transformation into the world’s largest single-use endoscopy company,” Ambu Chair Jørgen Jensen said in a […]
