Houston-based startup Braincheck Inc. scooped up $8 million in series A funding in a round led by S3 Ventures and Tensility Venture Partners, along with True Wealth Ventures and Nueterra Capital. Braincheck launched its digital cognitive assessment tool in 2015 and a cognitive care planning solution in 2018, and now the company is looking to broaden its footprint with physician practices, hospitals and health systems. Proceeds from the financing will help to build the company's sales and marketing and clinical development teams in Houston, as well as production development staff in Austin. Read More
As the U.K. pursues its divorce from the EU, smaller U.S. drug and device companies could be caught disproportionately in the collateral damage. Many of them already struggle with the cost of duplicative regulatory requirements involved in marketing their products in the EU, but those costs could increase under Brexit, according to a report released last week by the U.S. International Trade Commission on trade-related barriers impacting U.S. small- and medium-sized enterprises (SMEs) that export to the U.K. Read More
Despite a substantial build-up of expectations, the U.S. federal government has excluded device makers from a proposal to provide safe harbors under the anti-kickback statutes for value-based arrangements between providers and medical device makers. The news comes as a blow to device makers, who have argued for some time that value-based arrangements between industry and hospitals could save the taxpayer millions each year in Medicare spending, but the draft rule made note of concern that such arrangements might reduce competition among device makers. Read More
CEO Mark McKenna told BioWorld MedTech that San Diego-based Prometheus Biosciences Inc. has "cracked the code" in inflammatory bowel disease (IBD) – progress underscored by the firm's deal with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, which brings an undisclosed up-front payment and as much as $420 million more if development, regulatory and commercial milestones are reached in three programs. Read More
LONDON – There is no evidence for increased mortality in patients receiving paclitaxel-eluting stents and drug-coated balloons (DCBs) to treat peripheral arterial disease, according to the largest real-world safety analysis to date. The findings may come as a relief to many, particularly after a meta-analysis published in December 2018 led to safety warnings and restrictions on the use of coated and drug-eluting devices. Read More
