Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ICU Medical.
India is taking steps to separate how it regulates medical devices and pharmaceuticals, as it works to reduce its dependency on imports of devices and turn itself into a global hub for med-tech innovation and manufacturing.
Babson Diagnostics Inc. has line of sight for the commercial launch of its Betterway blood testing ecosystem, which is a less invasive way of taking blood and requires only one-tenth of the sample volume of venipuncture without sacrificing quality or accuracy. The company said that once the collection device developed in partnership with Becton Dickinson & Co. (BD) is cleared by the U.S. FDA, Betterway will be launched in Texas, where it already has established partnerships with retailers and where its commercial lab is up and running. In addition, Babson has fully validated a broad set of miniaturized assays that are ready for commercial processing in its CLIA-certified, CAP accredited laboratory.
Theken Companies LLC reported the acquisition of Visionair Solutions Inc. from the Cleveland Clinic, a deal that adds pulmonary therapy to its broad portfolio with Visionair’s 3D platform for the creation of silicon stents for central airway obstructions (CAOs). Terms of the transaction, which has officially closed, were not disclosed.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: CLS, Day Zero, Empyrean, Focalyx, Haemonetics, Innovimed, Inspira, Magcorp, Mainstay Medical, Marrow Access Technologies, Metox, Spartan Medical.
New hires and promotions in the med-tech industry, including: Aspen Medical Products, Co-Diagnostics, Elligo Health Research, GT Medical Technologies, Invitae.
Two papers published in Nature on Aug. 23, 2023, describe brain computer interfaces (BCI) with unprecedented capabilities for decoding brain activity into sentences, translating at speeds around half that of normal speech, and with vocabularies exceeding 1,000 words.
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