In the latest salvo of the ongoing battle between Apple Inc. and Masimo Corp. over the use of a blood oxygen technology, a U.S. federal appeals court paused an International Trade Commission (ITC) ban on Apple’s watches. Apple reported on Dec. 19 that it would pull the Apple Watch Ultra 2 and Apple Watch Series 9 from its website on Dec. 21 and from its retail locations after Dec. 24, in response to an exclusion order issued by the ITC in October. Read More
Two big pharma firms placed high offers on Dec. 26 to acquire companies focused on radiopharmaceuticals and cell therapies in what Evercore ISI analysts are calling a “good sign for the end of the year.” Read More
As calendar year 2023 limps to the finish line, a number of important regulatory developments emerged and then submerged, but one development that is also a non-development took center stage in the world of med tech. The U.S. FDA has proposed a regulation for lab-developed tests (LDTs), an issue that has been simmering for the better part of a decade thanks in no small part to Congress’ failure to pass legislation that would eliminate the FDA’s controversial approach to rulemaking.
Asia continues its push to be the global leader with precision health and artificial intelligence/machine learning (AI/ML) models for diagnosing disease. Most health care systems in Asia’s major markets include universal health care coverage and are leaning toward electronic health records, paving the way for seamless use of data. At the same time, AI/ML is making its way across the entire health care spectrum, including applications to diagnose breast cancer, kidney disease, cognitive decline, depression and even retinal imaging to detect cardiac disease. Read More
The U.S. Federal Trade Commission (FTC) and the Department of Justice (DOJ) have issued the final version of their updated merger guidelines for corporations, concluding a process that took a scant six months to complete following the issuance of the draft. Read More
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Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bluejay Diagnostics, Co-Diagnostics, Endologix, Inspira, Medsan, Olink, Retinalgenix, Somalogic, Standard Biotools, Thermo Fisher. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Coherus, Cvrx, Sofwave Medical. Read More
