Foundation Medicine Inc.'s pan-cancer detection test has received a nod from the FDA, making it one of the most comprehensive companion diagnostics to receive approval from the agency. Concurrent with FDA approval, the Centers for Medicare and Medicaid Services issued a preliminary National Coverage Determination (NCD) for the Foundationone Cdx.
Foundation Medicine Inc.'s pan-cancer detection test has received a nod from the FDA making it one of the most comprehensive companion diagnostics to receive approval from the agency. Concurrent with FDA approval, the Centers for Medicare & Medicaid Services issued a preliminary National Coverage Determination (NCD) for the Foundationone Cdx.
Boston Scientific Corp. is delaying its previously communicated timeline for the commercialization of its Lotus Edge aortic valve system. Initially, the company was going to file for a PMA for the device in January and relaunch the device in Europe by the end of 1Q18. This is the latest setback the Marlborough, Mass.-based company has faced with Lotus as it seeks to obtain a significant foothold in the transcatheter aortic valve replacement (TAVR) market, dominated by Edwards Lifesciences Corp. and Medtronic plc.
Biolinq Inc. has raised $10 million in a series A round to bring its pain-free blood glucose sensor to clinical trials. The financing was led by M Ventures, in collaboration with Hikma Ventures. Grey Sky Venture Partners, Three Leaf Ventures, Lifesci Venture Partners and a group of high-net-worth individuals specialized in the diabetes field also contributed to the round.
Medtronic plc had a lull in earnings for 2Q18 because of damage done to its facilities in Puerto Rico by Hurricane Maria. Massive wildfires in Northern California also contributed to the revenue decline.The Dublin-based company reported revenue of $7 billion, a decrease of 4 percent over 2Q17. However, the company brought in about $1.07 per share and was able to beat analysts' consensus of 99 cents per share.
Merit Medical Systems Inc. is set to acquire Becton, Dickinson and Co.'s (BD) soft tissue core needle biopsy offerings and C.R. Bard Inc.'s drainage products for $100 million in a deal set to close at the end of this year. The assets are being sold in conjunction with Franklin Lakes, N.J.-based BD proposed acquisition of Murray Hill, N.J.-based C.R. Bard for $24 billion. The merger was first reported in April.