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Today's Issue of BioWorld MedTech

Friday, September 22, 2017

Today's Headlines

Abiomed wins PMA for right heart failure device

Abiomed Inc. has added to its heart support portfolio with a PMA approval for the Impella RP heart pump for temporary right ventricular support after left ventricular assist device (LVAD) implantation, heart attack, surgery or transplant. The device was previously granted the FDA's humanitarian device exemption.

Columbia researchers reveal novel technique to link 'dark genome' to genetic diseases

Elucidating the role of genetics in understanding disease is a driving force for the diagnostic and biopharmaceutical industries. But, until now, much of the human genome has remained largely a mystery. Scientists have long focused on the portion that codes for proteins – but that represents only 2 percent of the human genome. Researchers at Columbia University Medical Center have developed a new technique, known as Orion, which interrogates the noncoding 98 percent, the so-called 'dark genome.'

Apollo endosurgery clarifies FDA letter on intragastric balloon safety

Following an FDA letter issued Thursday Aug. 10 to health care providers about possible risks with liquid-filled intragastric balloons, Apollo Endosurgery Inc. held a call on Friday to address the letter. During the call, executives with Apollo, maker of the Orbera intragastric balloon system, discussed the FDA letter regarding unexpected deaths of five patients who had received the balloons, though their deaths were not determined to be the result of the devices, said the company.


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