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The U.S. Food and Drug Administration (FDA) granted pre-market approval (PMA) to Abiomed's ( NASDAQ: ABMD ) Impella RP Flex with SmartAssist to treat acute right heart failure for up to 14 days. According to the FDA, PMA is the most stringent type of device ma...
Abiomed (Nasdaq: ABMD) announces that Impella RP Flex with SmartAssist has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA), the FDA’s highest level of approval, as safe and effective to treat acute right heart failure for up to 14 days. Impella RP F...
Summary Baillie Gifford’s 13F portfolio value decreased from ~$97.51B to ~$96.99B this quarter. They increased Shopify, Roblox, Zoom Video, and Twilio while reducing Albemarle Corporation and Li Auto ADR. The top three positions are Tesla Motors, Moderna, and MercadoLib...
Analysis of randomized controlled trial data shows non-Caucasian high-risk PCI patients significantly benefit from Impella-support Abiomed (Nasdaq: ABMD) announces a new program to address healthcare disparities in underserved communities, as new data provides an example...
Succeeds Derek Herrera after two-year term Patrice Sutherland, enterprise executive director at Integra Life Sciences, has been appointed Chairperson of the Board of Directors for MedTechVets, a nonprofit organization that helps military Veterans transition and gain employme...
The US FDA has accepted Abiomed's ( NASDAQ: ABMD ) post-approval study reports related to the pre-market approvals for its Impella heart pumps. The pumps are used for cardiogenic shock, high-risk percutaneous coronary intervention, post-cardiotomy cardiogenic shock, ca...
Abiomed (Nasdaq: ABMD) announces the U.S. Food and Drug Administration (FDA) has accepted and closed the post-approval study reports related to the pre-market approvals (PMA) for Impella heart pumps . The FDA’s action is another affirmation that Impella heart pumps are sa...
Summary Insulet Corporation has an interesting business model and management continues to grow the company's top line nicely. However, profits and cash flows have been showing signs of weakness and the stock looks very pricey at this time. Investors should be careful about thi...
The U.S. Food and Drug Administration (FDA) granted 510(k) clearance to Abiomed's ( NASDAQ: ABMD ) Impella Low Profile Sheath. Compared to the existing 14 French (Fr) sheath used for placement Impella CP, the new sheath maintains the same inner diameter, but reduc...
Smaller Sheath Simplifies Access and Improves Ease-of-Use The United States Food and Drug Administration (FDA) has granted 510(k) clearance to Abiomed (Nasdaq: ABMD) for its Impella Low Profile Sheath. Compared to the existing 14 French (Fr) sheath used for placement of ...
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Abiomed (Nasdaq: ABMD) announces the United States Food and Drug Administration (FDA) has approved the version of Impella ECP that will be used in the Impella ECP Pivotal Trial, and the first two patients have been enrolled in the trial. Amir Kaki, MD, director of mechanical circulatory support...
Steel Dynamics Set to Join S&P 500; Super Micro Computer to Join S&P MidCap 400 Steel Dynamics Set to Join S&P 500; Super Micro Computer to Join S&P MidCap 400 PR Newswire NEW YORK , Dec. 19, 2022 /PRNewswire/ -- S&P MidCap 400 constituent...
Abiomed (Nasdaq: ABMD) announces the first three patients in the world have been treated with Impella RP Flex with SmartAssist, Abiomed’s newest heart pump for patients experiencing right heart failure. All three patients have now been successfully weaned off Impella support and two have...