The U.S. FDA typically announces its inspections at facilities located outside the U.S. – a courtesy not extended to domestic manufacturing sites. This is about to change per an agency press release quoting commissioner Marty Makary as describing the disparate treatment as a double standard.
The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 said.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cytel, Dignitana, DNV, Icotec, Mediso, Nested Knowledge, Osteotec, Paxman, Superconducting Systems.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb.
Planting seed money and “wishing” is not enough to claim “irreparable harm” to secure a preliminary injunction or to establish the standing required to appeal a patent board decision, the U.S. Court of Appeals for the Federal Circuit ruled May 7 in two decisions involving Incyte Corp. and Sun Pharmaceutical Industries Ltd.
The promise of mesenchymal stem cells (MSCs) to heal heart disease could be around the corner thanks to a new delivery method tested by regenerative medicine company Cynata Therapeutics Ltd.
Despite the uncertain macro environment created by the threat of reciprocal tariffs on goods into the U.S., some investors are still upbeat about the med tech sector. Even with changes at the HHS and disruption to product approvals throughout the FDA, venture capital investors remain cautiously optimistic.
News of the sale of Masimo Corp.’s consumer audio unit may be music to the ears of investors, even at the steep discount from its original purchase price. Samsung Electronics Co. Ltd.’s Harman International Industries Inc. unit snapped up the Sound United business for about $350 million – roughly one-third of the $1.025 billion Masimo paid for the company in 2022.
The recent 510(k) clearance by the U.S. FDA for a core part of Precision Neuroscience Corp. brain-computer interface technology is certainly a boon for the company, and others developing the devices. For the millions of people suffering from health disorders, such as motor neuron disease, spinal cord injury or severe stroke, its sign that a solution which could transform their lives could be just a few years away.
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