Orthofix Medical Inc. and Seaspine Holdings Corp. signed a definitive agreement to combine in an all-stock merger of (near) equals. Following the close, Orthofix shareholders will own approximately 56.5% of the company and Seaspine shareholders will own approximately 43.5%. The new company’s name will be announced prior to the transaction’s anticipated first quarter of 2023 closing. Read More
Heartbeam Inc. has been awarded a patent for what it called “the first and only” 3D-vector, 12-lead ECG platform for heart attack detection, this in conjunction with a credit card-sized device inside a consumer’s wallet for personal monitoring. The company said it can record and remotely transmit a set of cardiac signals to a physician for review so that patients at high risk of cardiac arrest are not left alone deciding if an ER visit is warranted. Read More
The draft rule for the Medicare physician fee schedule (MPFS) for calendar year 2022 included a revised definition of the term “physician-owned distributorship,” or PODs, but the associated data collection requirements do not go into effect until January 2023. However, Amanda Johnston, managing attorney at Gardner Law of Stillwater, Minn., said recently that there is the possibility that this new definition could become a subject for enforcement action under the Anti-Kickback Statute (AKS), thus elevating the legal risks for device manufacturers who have not updated their compliance practices. Read More
Rsip Vision Ltd. has debuted a new tool for making 3D reconstructions of the ureter. The vendor-neutral tool, which uses artificial intelligence (AI) and deep-learning algorithms to make 3D reconstructions, is available to third-party medical device companies using three-arm imaging and viewer solutions. Read More
The U.S. FDA’s agreement with industry for the fifth device user fee agreement (MDUFA V) included a pilot for the total product life cycle advisory program, or TAP, which is designed to ensure that potential device problems are addressed before production of the finished device design. However, the agency acknowledged that the TAP program will require significant numbers of new hires, which promises to be a significant hurdle given that the agency struggled to meet its hiring goals under the previous device user fee agreement. Read More
At the third time of asking, Scpharmaceuticals Inc. has seen its subcutaneous loop diuretic, Furoscix (furosemide), approved by the U.S. FDA for patients with worsening heart failure, although the news was greeted initially by a shock slump in the firm’s share price. Read More
Upheaval at the Biotechnology Innovation Organization (BIO) has resulted in a sudden leadership change. Rachel King, a longtime member of the organization’s leadership and co-founder and former CEO of Glycomimetics Inc., will serve as interim president and CEO. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Accuray, Castle Biosciences, Pixium Vision. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptive Biotechnologies, Beckman Coulter, Bone Therapeutics, Compass, Epic, Fitbit, Fujirebio, Icad, Kiyatec, Neuropace, Nico, Pretaa, Sebia, Self-screen, Solis, Stocastic, Zeus Scientific. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biolab Sciences, Carl Zeiss Meditec, CTL Amedica, Icecure Medical. Read More
