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The warning letter claims Outset Medical made assertions outside of the current indications for its Tablo dialysis system and needs clearance for a device accessory.

Kerecis’ fish skin biologic, which aids tissue regeneration, helped drive the company’s sales to $74.5 million last year.

Noticias de la actualidad científica y tecnológica del 19 de junio de 2023.     …

Medtronic has begun processing orders and will start shipping devices over the next few weeks.

The health system said data like name and contact details, though not clinical information, was stolen from an external storage location and posted online.

A New York judge ruled that Teladoc had detailed risks of its $18 billion Livongo acquisition and that, while the company may have been optimistic regarding its operations, it did not falsify facts or statements.

Hospital groups said the proposed rule is an important step toward restitution for years of 340B underpayments, but they criticized regulators for proposed rate decreases and a lack of additional interest payments.

Infinity Pharmaceuticals Provides Additional Information on MARIO-8 Study Evaluating Eganelisib in Combination with the PD-1 Targeted Checkpoint Inhibitor Pembrolizumab (KEYTRUDA ® ) in Patients with Squamous Cell Cancer of the Head and Neck (SCCHN).

Melinta Therapeutics, LLC announced today a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to advance two antibiotics currently FDA-approved for adults, BAXDELA® (delafloxacin) and VABOMERE® (meropenem and vaborbactam), for use in pediatrics.

Race executes worldwide license agreement with City of Hope, one of the largest cancer research and treatment organisations in the United States.