TransMedics (NSDQ:TMDX) announced today that the doctors at two hospitals performed the first U.S. heart transplants using donor hearts that were resuscitated using the company’s organ care system (OCS). The transplants from donation after circulatory death (DCD) took place at Duke University Hospital in Durham, N.C. and Massachusetts General Hospital in Boston. In a DCD procedure, […]
FDA: Abiomed Impella RP survival rate steady when appropriate patients are implanted
The survival rate of right-heart failure patients treated with the Abiomed (NSDQ:ABMD) Impella RP heart pump remained about the same during the latest round of post-approval studies, according to the FDA. That latest rate of survival 30 days post-explant, post-discharge survival or switch to another therapy rate was 72.7%, or 16 out of 22 patients among […]
Ra Medical shares begin recovery following report of Q3 losses, material weakness
Ra Medical Systems (NYSE:RMED) reported third-quarter losses of $17.4 million last week amidst an internal investigation into failures surrounding its Dabra laser catheters and other shortcomings. That investigation, announced in August, recently revealed deficiencies in its internal controls that constitute a material weakness and could have resulted in material misstatements or omissions to its financial statements […]
Baxter spending $350m to acquire surgical adhesion barrier tech from Sanofi
Baxter (NYSE:BAX) said today that it will buy the Seprafilm adhesion barrier and related assets from Sanofi (NYSE:SNY) in what is expected to be a $350 million deal. The purchase is expected to close no later than the first quarter of 2020. A Bloomberg report in October hinted that a deal might be in the work. “While […]
Appeals court tosses former Abiomed Asia exec’s lawsuit
This article has been updated with a comment from Abiomed. A federal appeals court has dismissed the wrongful termination law suit of a former Asia VP for Abiomed (NSDQ:ABMD). The three-judge panel ruled on Nov. 27 that Keisuke Suzuki failed to prove that Abiomed owed him compensation in the form of company stock options for […]
Baxter gets filing deadline from stock exchange
The New York Stock Exchange notified Baxter (NYSE:BAX) on Friday that the company has until May 20, 2020 to file its third-quarter financial report and any subsequent delayed filings to regain compliance with exchange’s listing standards. The Deerfield, Ill.–based healthcare products company announced Nov. 15 that it was conducting an internal probe into its foreign […]
Axonics places $110 million public offering
Sacral neuromodulation device-maker Axonics Modulation Technologies (NSDQ:AXNX) has commenced a proposed public offering worth more than $100 million in shares of its common stock. The offering is placed at $110 million, with Irvine, Calif.-based Axonics expecting to offer $100 million in shares to go along with $10 million in shares offered by selling stockholders. Axonics plans […]
Carlisle completes Providien purchase
Carlisle Companies (NYSE:CSL) announced today that it has completed its acquisition of Providien for an undisclosed amount. San Diego-based Providien provides solutions for global medical technology OEMs, such as contract manufacturing, precision machining and metals, thermoforming and injection molding. The acquisition, which was initially announced last month, is part of Scottsdale, Ariz.-based Carlisle’s plan to […]
Stent makers point to quality-of-life findings by massive federal study
The giant federal study that found the use of stents in stable heart-disease patients is no better than drugs to treat clogged arteries reached another, less-hyped conclusion. Manufacturers of stents for percutaneous coronary intervention (PCI) note that the Ischemia study also concluded that patients who undergo a stenting procedure have a better quality of life. They suffer […]
Abiomed stock recovers some as company further questions critical Impella studies
Shares of heart pump company Abiomed (NSDQ:ABMD) recovered a bit today — a day after the company’s stock took a 20% dive after two critical studies came out of American Heart Association’s Scientific Sessions. The two separate studies — one led by researchers in St. Louis, the other out of San Francisco — suggested potentially serious complications […]
Getinge shares drop on news of more deaths, injuries linked to faulty IABPs
Shares of Getinge (STO:GETI-B) dropped 5% today on news that the FDA had received 60 more reports of adverse events — including two deaths and one serious injury — related to the company’s Maquet/Datascope intraortic balloon pumps (IABP). The FDA said the new reports have come in since it issued a letter in November 2018 […]
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