Verisante, Astoria join forces for upper GI cancer detection
Verisante Technology
Canada’s Verisante raises $1.1M for cancer detection
Holaira raises $10M for lung device | Wall Street Beat
Medical device company Holaira said it drummed up $10 million, changed its name and moved its headquarters.
Formerly known as Innovative Pulmonary Solutions, Holaira said it plans to use the Series C round to develop its minimally invasive devices to treat obstructive lung disease. All of Holaira’s existing backers participated, namely Advanced Technology Ventures, Morgenthaler Ventures, Split Rock Partners, and Versant Ventures.
Boston Scientific’s CEO defends the troubled Guidant buyout | Wall Street Beat
Boston Scientific’s (NYSE:BSX) interim CEO Hank Kucheman still believes in the company’s ill-fated acquisition of Guidant Corp., a deal worth $26 billion that was followed by recalls, lawsuits and criminal charges.
Becton Dickinson lands clearance for 10-minute flu test | Regulatory Roundup
Becton Dickinson & Co. (NYSE:BDX) won FDA 510(k) clearance for its BD Veritor 10-minute diagnostic test for influenza A and B last month, amid rumors that the Franklin Lakes, N.J.-based company is ripe for buyout.
Veritor is the first rapid flu test with a digital readout, while older tests are slower, less accurate and more difficult to interpret, according to BD.
FDA approves Berlin Heart pediatric heart pump | Regulatory Roundup
Berlin Heart’s Excor pediatric VAD
The FDA granted a humanitarian device exemption to Berlin Heart’s Excor pediatric ventricular assist device, after a unanimous recommendation from the federal watchdog agency’s Circulatory System Devices Advisory Panel.
The pediatric VAD is a mechanical cardiac assist device for critically ill pediatric patients suffering from severe heart failure. The system supports patients from newborns to teenagers, helping to keep them alive while they’re awaiting heart transplantation.
GE Healthcare begins PMA process for 3D breast scanner | Regulatory Roundup
GE Healthcare (NYSE:GE) filed the first module of its pre-market approval application for the breast tomosynthesis option of its Senographe Essential system.
The health care giant said the first submission included a device description and non-clinical information, including "phantom testing," and detector performance evaluation. The system is intended as an add-on option for the Senographe Essential to produce 3D images for screening and diagnosis of breast cancer.
