The FDA has undertaken several new actions in connection with breast implants, including a new restriction on distribution to implant centers that review a pre-implant checklist with patients receiving implants. However, the agency has also mandated that manufacturers add a black-box warning of potential adverse events, such as the risk of developing anaplastic large cell lymphoma (ALCL).
PARIS – Mauna Kea Technologies SA reported the commercial launch of a new generation of its in vivo cellular imaging for diagnostics in gastroenterology. At the same time, the company is deploying its new needle-based and miniprobe-based multidisciplinary confocal laser endomicroscopy platform in the U.S., as well as in France, Germany and Italy.
Zap Surgical Systems Inc. is debuting its noninvasive brain tumor treatment to the European market through an agreement with Centre de Cancérologie de la Porte de Saint-Cloud (CCPSC). The Boulogne-based center, which is part of the American Hospital of Paris, said it expects patients to access the treatment by Fall 2022.
DUBLIN – Novadip SA raised €19 million (US$22.1 million) in a first close of a series B round to progress its autologous bone regeneration therapy, NVD-003, on either side of the Atlantic. The company is also working on an allogeneic regenerative approach, which is still preclinical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3D Systems, 3H Medi Solution, Aktana, BD, Bioventus, Castle Biosciences, Densitas, Foundation Medicine, Fujirebio Europe, H.U. Group Holdings, Hearing Assist II, Ion Beam Applications, Innerscope Hearing Technologies, Intersect ENT, Medical Guardian, Medscope America, Misonix, Ople, Physiq, Science 37, Trad Tests & Radiations, Volumetric, X-Chem.
In an effort to advance a fiscal 2022 spending package through a divided Congress, U.S. President Joe Biden released the framework for his Build Back Better agenda Oct. 28 – minus provisions that would allow Medicare to directly negotiate at least some prescription drug prices.
The U.S. Department of Health and Human Services is proposing to withdraw or repeal a Trump-era rule imposing expiration dates on most of the rules implemented by the department and its agencies, including the FDA.
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