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The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software is...
This digest covers key virtual and digital health regulatory and public policy developments during September 2023 from the United States, United Kingdom, and European Union.
The warning letter is the latest indication of the fresh scrutiny the FDA is paying to software tools and decision aids.
Johnson & Johnson (NYSE: JNJ), the world’s largest, most diversified healthcare products company, and Abiomed (NASDAQ: ABMD), a world leader in breakthrough heart, lung and kidney support technologies, today announced that they have entered into a definitive agreement under which Johnson & Johnson will acquire ...
Abiomed (NASDAQ:ABMD – Get Rating) and TELA Bio (NASDAQ:TELA – Get Rating) are both medical companies, but which is the superior business? We will compare the two companies based on the strength of their risk, institutional ownership, earnings, profitability, dividends, valuation and analyst recommendations. Risk & Volatility Abiomed has a beta of 1.34, suggesting that […]