The Medical Device Authority of Malaysia reported on Aug. 22 the piloting of a bilateral medical device approval program with Singapore to streamline the review and launch of medical devices in both countries.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alveo, Core Sound Imaging, Corewell Health, Imfusion, Pavmed, Quest, Siemens Healthineers, Tenovi, Ultralinq, Varian, Versonics, Vivo Care.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott Laboratories, Brightonix Imaging.
After making a significant strategic investment in Oxganox Ltd. earlier this year, Terumo Corp. quickly returned to buy the organ preservation company. On Aug. 25, the companies announced that Terumo would acquire Organox for $1.5 billion, marking Terumo’s entry into the organ transplant sector. The transaction is one of the largest exits ever for the U.K. med-tech sector.
The U.S. and the EU have signed off on a trade deal, which makes some important provisions for generic pharmaceuticals. However, Medtech Europe said in an Aug. 21 statement that it is concerned about the exclusion of medical technology, given the potential for negative effects on patient care.
The U.S. FDA has announced a class I recall for the Wallstent Monorail system by Boston Scientific Corp. of Marlborough, Mass, a device for treatment of carotid artery stenosis. The company advised customers in early July to return any unused inventory because the inner diameter of the stent is narrower than intended, which may lead to difficulties in extracting the delivery device after placement of the stent.
Lee Dae-hong founded Aivis Inc. in January 2021 as an AI-powered pathology software company, having led the development of the world’s first commercial under-display fingerprint recognition algorithm that was later incorporated into the Galaxy S10 and Galaxy A series of smartphones of Samsung Electronics Co. Ltd.
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