Dexcom Inc. received U.S. FDA clearance for its Smart Basal CGM-integrated basal insulin dosing optimizer. Designed for adults with type 2 diabetes using glargine U-100 long-acting insulin therapy, Smart Basal uses data from Dexcom’s G7 15 Day sensor with doses logged by the user to personalize recommendations and adjust long-acting insulin doses, with direction from the patient’s health care provider. Read More
The recent strategic partnership Siemens Healthineers AG recently entered into with Boston Scientific Corp. to develop and commercialize an Acunav 4D intracardiac echocardiography catheter could drive “significant growth” for the company, Jochen Schmitz, CFO, at Siemens, told delegates at the Jefferies Global Healthcare Conference, in London. Read More
The European Commission posted a series of proposed legislative updates, including the AI Act, which might not come into force for the med tech industry until August 2028 under the terms of this proposal. Read More
U.S. and European organ-on-a-chip specialty biotechnology companies are driving development of organ-on-a-chip technologies, fueled by the U.S. FDA’s decision to phase out animal testing for investigational new drugs. Read More
Med-tech M&A activity cooled in October, with the total disclosed deal value reaching $1.68 billion, a step down from September’s $4.84 billion and well below several stronger months earlier in the year. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Archéon Médical, Deephealth, Exact Imaging, Intravent, Nexalin, Quanterix. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dexcom, Rapidai, Vesalio. Read More