Medtronic plc reported promising results from a feasibility study of its In.Pact 0.014 drug-coated balloon (DCB) in critical limb ischemia (ICL) patients with chronic total occlusion (CTO) in the infrapopliteal arteries. Read More
The news that the U.S. FDA has opened a new digital health office carries some significant expectations for stakeholders, expectations that may take time to meet. More than one participant in the Oct. 19 FDA listening session for the Digital Health Center of Excellence (DHCoE) called on the FDA to ensure that this new center provides more regulatory clarity regarding a number of products, a task that may be some time in coming, given the need to harmonize with other national and international regulatory entities. Read More
Inari Medical Inc.'s Flowtriever device appears to offer a safer and more effective option for pulmonary embolisms than current treatment with thrombolytics or open embolectomy, according to prospective study presented at the TCT Connect 2020 conference. Read More
Royal Philips NV is launching its Quickclear mechanical thrombectomy system in the U.S. four months after obtaining FDA clearance. “Quickclear's intuitive design simplifies the entire thrombectomy procedure work flow. Our new medical device can help bring cost-effective solutions in both the hospital and outpatient care settings,” Chris Landon, senior vice president & business leader, image guided therapy devices at Philips, told BioWorld. Read More
TORONTO – What’s the difference between an organ transplant container tucked under a paramedic’s arm and an ordinary beer cooler packed with ice? Surprisingly, not much, according to researchers at London, Ontario’s Western University. They’ve come up with a portable, temperature-controlled container that prevents spoilage of donor organs during transport to the operating room – and of potential vaccines. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA’s cybersecurity discussion paper emerges; CMS eyes MAC default for Allomap coverage; CMS floats draft coverage for CRC screening test. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M, Abbott, Apollo Medco, Beahm Designs, BD, Beroni Group, Caredx, Eko, Genscript Biotech, Labcorp, Machine Solutions, Medovate, Plexision, Quidel, Vygon. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biosensors International, Centogene, DNA Genotek, Dxterity, Everlywell, Fresenius Medical Care, Ossio, Thermo Fisher Scientific. Read More
Keeping you up to date on recent developments in cardiology, including: Biobeat's wearable monitoring device shows promise in swine model; Neutrophils are literal obstacle to stroke recovery; Neovessel formation eyed in treating cardiovascular diseases. Read More
