Senseonics Holdings Inc. is one of the latest med-tech companies to release its quarterly numbers, revealing sales of $261,000, a decline of -94.3% year-over-year. That figure may have fallen below SVB Leerink Research’s estimate of $1.6 million and consensus at $1.4 million “given the company's well-telegraphed ongoing strategic review,” wrote Danielle Antalffy in a note. Still, Senseonics had some good news, which Antalffy heralded as “very positive.” That came in the form of a financial and strategic partnership with Ascensia Diabetes Care that revolves around a global commercialization and distribution agreement and a concurrent financing deal. Read More
Israeli startup Bluewind Medical Ltd. has begun enrolling patients at U.S. sites in a pivotal trial of its Renova Istim implantable tibial neuromodulation system for the treatment of overactive bladder. Read More
Cryoablation technology firm Icecure Medical Ltd. raised $6 million (₪20.7 million) in an oversubscribed equity offering. The Caesarea, Israel-based company (TASE:ICCM) plans to use the funds for continued expansion of operations in the U.S., Europe and Asia. Read More
The Medical Device Innovation Consortium (MDIC) has worked diligently to stand up the National Evaluation System for health Technologies (NEST) as a functioning program, and the first iteration, known of course as NEST 1.0, is now up and running. Read More
“There’s a difference in knowing something and realizing something. We’ve known for quite a while now that we’re too dependent on other countries for our medical supplies. But during this pandemic, I think we’ve realized it,” U.S. Rep. Buddy Carter (R-Ga.) said at a recent congressional hearing on the progress being made in developing COVID-19 vaccines. Read More
HONG KONG – Diagnostic kits are in the spotlight as Vietnam battles a resurgence of COVID-19 cases, after a wave of community infections started appearing in late July. A new outbreak has infected more than 220 people since July 25, most of whom came from the coastal city of Da Nang. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Babylon, Beyond Air, Exthera, Neurologica. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alume, Caligor, Blackrock Microsystems, Canon Medical Systems USA, Caris Life Sciences, Companion Medical, Curepsp, Dreamtech, Elevation Oncology, E7 Health, Epitomee Medical, Hemogenyx Pharmaceuticals, Hologic, Irras, Lianbio, Medcall, Medtronic, Mcfarlane Medical, Microgendx, Nestlé Health Science, Onlume, Painteq, Pccw Global, Perimeter Medical Imaging AI, Promega, Quidel, Sensifree, Sure Universal, Syapse, Titan Medical, Trendlines Group, Vonco Products, Wyss Center for Bio and Neuroengineering, Zebra Medical Vision. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Life Spine, Magventure, United Imaging. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Allergan, BTL Industries, Spartan Bioscience, Zimmer Medizinsysteme. Read More
Keeping you up to date on recent developments in oncology, including: Novel nanoparticle releases therapy via DNA sequence trigger; In AML, collapse prevents relapse; The next great nano-thing: nanopaper. Read More