Diagnostics & Healthcare News

It’s an unprecedented time for innovation and regulation in medical devices. The Food and Drug Administration announced that 2018 was their most successful year in approving medical devices. 106 devices received the FDA’s marketing green light, breaking the record of 99 in 2017. These devices included automated insulin dosing systems for children as young as 7, the world’s…

Scrolling through the GoFundMe website reveals seemingly an endless number of people who need help or community support. A common theme: the cost of health care. It didn’t start out this way. Back in 2010, when the crowdfunding website began, it suggested fundraisers for “ideas and dreams,” “wedding donations and honeymoon registry” or “special occasions.”…

Jerusalem-based Teva Pharmaceuticals’ sensor-packed, app-connected digital inhaler has recently received marketing approval from the US FDA, according to a release from the company. The device will first become available next year through a “small number” of healthcare system pilot partnerships, with a full national launch currently planned for 2020. Teva’s ProAir Digihaler is indicated for…

Nearly a year after bagging the option to acquire Millipede, Boston Scientific has pulled the trigger. When the pair inked the agreement in January, Boston Scientific handed over $90 million for a portion of the mitral regurgitation startup’s shares. Now, the devicemaker is paying $325 million to pick up the rest of Millipede’s shares. The deal was…

Acorda Therapeutics said this week that the FDA approved its Inbrija device for the intermittent treatment of  “off” episodes in people with Parkinson’s disease. The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes are caused by low levels of dopamine between doses of the standard oral Parkinson’s therapy,…

Women who experience false-positive mammograms are at an increased risk of breast cancer for more than a decade, according to new research published in the British Journal of Cancer. The authors collected data from more than 1.1 million women from three population-based screening programs—one from Denmark, one from Norway and one from Spain—for the study. Patients were between…

GE Healthcare reportedly filed confidentially for an initial public offering as it readies a spinout of its GE Healthcare business. The Boston-based industrial giant tapped Goldman Sachs, Bank of America, Citigroup, JPMorgan Chase and Morgan Stanley for help with the flotation, according to Bloomberg, which cited sources “who asked not to be identified as the details…

Itamar Medical, a company that develops, manufactures, and markets non-invasive diagnostic medical devices for sleep apnea with a focus on the cardiology market, today reported financial results for the third quarter of 2018. “We are pleased with the solid increase in third-quarter revenues, which reflects the growing recognition among U.S. cardiologists of the benefits that…

The FDA today released plans for updating its 510(k) clearance pathway, including a push to move away from using predicate devices over 10 years old and the creation of a new alternative 510(k) pathway that will allow approval based on objective safety and performance criteria. In an official posting, FDA head Dr. Scott Gottliebb and…

Boston Scientific today announced it has reached an agreement on the terms of a recommended offer to acquire BTG plc., a company headquartered in the United Kingdom, which develops and commercializes products used in minimally-invasive procedures targeting cancer and vascular diseases, as well as acute care pharmaceuticals. The transaction has been unanimously approved by the boards…