The America Invents Act of 2011 was designed to provide a durable overhaul of the U.S. patent system, but the inter partes review (IPR) process has drawn fire from inventors as a patent-killing machine. The Senate is considering a new bill to address some of these concerns, but witnesses at a hearing this week were anything but united in their assessment of the status quo, making it difficult to forecast the fate of this latest effort at patent reform. Read More
The U.S. FDA granted Roche Holding AG breakthrough device designation for its Elecsys Neurofilament Light Chain test for multiple sclerosis. The Elecsys NfL test can aid in the detection of disease activity in adults, 18-55 years old, with relapsing-remitting multiple sclerosis or secondary progressive multiple sclerosis. It also provides critical information for managing the disease. Read More
Glucometrics Co. Ltd. is rolling out its self-developed application programming interface (API) for diabetes care in steps, and the latest partnership with G2E Co. Ltd. is underway to develop a smart insulin pen loaded with the interface. Read More
While med-tech deals were well below average the past two months, cumulative values are up 47.67% over the same period last year. Through October, the total worth of med-tech deals reached $9.97 billion, rising from $6.75 billion in the corresponding period in 2022. Read More
Emboline Inc. is seeking patent protection for methods and apparatus for embolic protection during cardiac procedures being performed on atrial outlet valves, namely, the mitral and tricuspid valves.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Illumisonics, Medtronic, Iglucose, Spinex. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Exagen, Kdx, Labforce, MCT Lifesciences, Olympus, Seisa, Tekniplex. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acon, Arup, 2curex. Read More
