Mauna Kea wins expanded CE Mark for Cellvizio
Mauna Kea Technologies
The law of unintended consequences: Transparency rules may harm sickest patients | MassDevice.com On Call
MASSDEVICE ON CALL — A new study out of Brigham & Women’s Hospital in Boston suggests that transparency rules might have negative consequences for very sick heart patients.
The study evaluated the frequency of coronary stent implantation in 116,227 Bay State patients, finding that "outlier" hospitals – pegged for having higher-than-average death rates – were less likely to accept the sickest patients.
FDA gives Mauna Kea the green light for its optical biopsy miniprobe
Mauna Kea Technologies (ENT:MKEA) landed FDA clearance for its AQ-Flex 19 mini-probe, which is already on the market in Europe. The device is designed to biopsy pancreatic cysts during endoscopic needle aspiration procedures in the digestive tract.
China approves Mauna Kea’s CellVizio cancer imaging system
The China State Food & Drug Administration approved Mauna Kea Technologies’ Cellvizio confocal endomicroscopy system, a device design to see cancer faster.
Report: Baxter’s in the hunt for $4B Gambro buyout | Wall Street Beat
The IRS gears up to tackle Obamacare | MassDevice.com On Call
MASSDEVICE ON CALL — The U.S. Internal Revenue Service should have its hands full in dealing with implementation of the new taxes and rules contained in the Affordable Care Act.
The federal agency must handle more than 40 changes to the tax code as well as make sure appropriate recipients get new tax credits and individuals and businesses pay penalties for any non-compliance.
Former Medtronic exec named head of new EU device & Dx alliance | Personnel Moves
Nexstim wins FDA OK for pre-neurosurgery speech mapping | Regulatory Roundup
Medgenics wins FDA OK for Epodure trial | Regulatory Roundup
J&J veteran Donald Casey takes helm of medical segment at Cardinal Health | Personnel Moves
Cardinal Health appointed Donald Casey Jr. to lead its $9 billion medical products and services division, effective next week.
