Technology & Devices

US health regulators cleared use of a first-of-its-kind device to treat dialysis-related amyloidosis (DRA). The US Food and Drug Administration (FDA) authorized use of Lixelle Beta 2-microglobulin Apheresis Column under its pathway for medical devices that treat rare conditions. The device is used to treat DRA, a chronic, progressive condition …

Mayo Clinic and Gentag, Inc. have teamed up to develop next-generation, wearable biosensors designed to fight diabetes and obesity. The companies have reached a joint intellectual property (IP) agreement to develop the first-of-its-kind, wearable patch sensors, which are wireless and the size of a small bandage. The sensors are designed …

Medical device maker Boston Scientific Corp is buying Endo International’s men’s health and prostate businesses for up to $1.65 billion. The companies have entered into a definitive agreement, under which Boston Scientific will acquire the American Medical Systems urology profile, which includes the Men’s Health and Prostate Health businesses, for …

DNAnexus Inc., a pioneer in cloud-based genome informatics and data management, recently announced that Intermountain Cancer Genomics is now utilizing its technology platform for the center’s personalized treatment options for cancer patients. The DNAnexus platform allows Intermountain Cancer Genomics to run its bioinformatics pipeline in the cloud, providing unmatched computational …

Genmab A/S and BioNovion struck a deal to evaluate several DuoBody product candidates targeting immune checkpoints. The companies announced that they have entered into a co-development and commercialization agreement to evaluate the product candidates. Genmab and BioNovion will contribute panels of antibodies for the creation of bispecific antibody products using …

The US Food and Drug Administration (FDA) has issued final guidance documents regarding the agency’s approach on the regulation of medical device data systems (MDDS) and mobile applications. MDDS is described as hardware or software that transfers, stores, converts formats, and displays medical device data from a variety of other …

The US Food and Drug Administration (FDA) has approved the first electronic nebulizer to deliver cystic fibrosis patients their therapy. The agency approved PARI’s eRapid nebulizer system to deliver Genentech’s Pulmozyme (dornase alfa [recombinant human DNase] for treatment of cystic fibrosis (CF). According to PARI, eRapid cuts the average treatment …

New mobile health (mHealth) tools have demonstrated effectiveness in aiding HIV patients better manage their disease through improved medication adherence. After analyzing data regarding the effectiveness in mobile pharmacy apps in helping HIV patients, mscripts and Avella Specialty Pharmacy found that HIV patients using a mobile app which provides refill …

Health care giant Johnson & Johnson (J&J) is the first device-maker to agree to broadly share clinical trial data for its medical devices and diagnostics with a medical school. J&J struck a deal with the Yale University Open Data Access (YODA) Project to make results from its clinical trials of …