Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insulet, Huizhou Jinghao, Ludica Medical, Medtronic, Vuno.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Pleural Dynamics.
Wandercraft SAS has begun commercial operations of its exoskeleton, Atalante X, in the U.S., offering another solution to the millions of people living with mobility impairments. The company also formed a partnership with the Kessler Foundation whose research team will investigate the possible benefits of the Atalante X for neurologically impaired patients, including those recovering from stroke, spinal cord injuries and motor neuron disease.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cardioflow, Edwards Lifesciences, Spectral AI.
A week before the U.S. Senate Health, Education, Labor and Pensions Committee is scheduled to vote on the confirmation of Monica Bertagnolli as the next NIH director, she faced a grilling by the committee fueled by drug pricing agendas and deals the Biden administration made with certain lawmakers to advance her nomination.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Praxis Medical, Seastar Medical, Telesair, Vyspine.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Flobio, GE Healthcare, Werfen.
The recent greenlight from European regulators to Tasso Inc. to market its Tasso+ device in the EU brings another solution to the market for blood collection Tasso has developed the Tasso+, a single-use blood lancing device that collects a microliter capillary blood from the upper arm. Tasso claims that it is the first device of its kind to get both CE mark and U.S. FDA approval.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bonesupport, Burning Rock Biotech, Establishment Labs.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Endonovo Therapeutics, Foundation Medicine, Infobionic, Medtronic.
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