Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bonesupport, Clear Guide Medical, Dexcom, Diapharma, Sekisui.
Researchers from the University of Edinburgh seek protection for an algorithm developed using artificial intelligence that could be used by doctors to diagnose heart attacks more quickly and effectively.
The World Trade Organization wrapped up its 13th ministerial conference and, as the saying goes, no news is good news. Life science trade associations in the U.S. lauded the end of the conference without an extension of intellectual property rights waivers for therapies and diagnostics for the COVID-19 pandemic, although this outcome was not entirely surprising.
Phagenesis Ltd. raised $42 million in a series D financing round for its neurostimulation therapy, Phagenyx, which treats swallowing dysfunction. The funds will primarily support commercialization of the device in the U.S. where there is a huge unmet clinical need in dysphagia treatment, Reinhard Krickl, CEO of Phagenesis, told BioWorld.
The U.S. FDA announced several new and updated recalls recently, including a new recall of incubators made by Wipro GE Health Pvt. Ltd., of Bangalore, India, which may be subject to an increased risk that the infant may fall out of the system.
Haemonetics Corp. appears ready to make a bit of a retro investment, as it entered into a definitive agreement to acquire Advanced Cooling Therapy Inc. (dba Attune Medical) for $160 million at closing plus undisclosed additional contingent payments. Attune manufactures the U.S. FDA-cleared Ensoetm device, which cools the esophagus during radiofrequency cardiac ablation procedures, a treatment for atrial fibrillation whose days appeared numbered.
In a move to build up its dominance in the radiopharma market, Telix Pharmaceuticals Ltd. said it plans to acquire radioisotope production technology firm Artms Inc. and its advanced cyclotron-based isotope production platform, manufacturing plant and stockpile of ultra-pure rare metals.
While members of the U.S. FDA’s Imaging Drugs Advisory Committee weren’t blown away March 5 by the trial performance of Lumicell Inc.’s Lumisight (pegulicianine) in helping breast cancer patients avoid second surgeries due to negative margins following a lumpectomy, they voted 16-2, with one abstention, that the benefits of the imaging drug outweigh its risks, even though those benefits are incremental.
Rhythm Diagnostic Systems SA received CE mark approval from EU authorities for Multisense, a wearable device that continuously monitors patients remotely. The company looks to market the device first in France and Germany.
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