Alivecor Inc. has elevated its patent dispute with Apple Inc. to the U.S. International Trade Commission (ITC) in a move that could damage the latter’s foray into digital health. Alivecor is alleging that Apple, of Cupertino, Calif., has infringed on Alivecor patents for electrocardiogram monitoring technology, a development that may foreshadow a continuing legal struggle between the two companies for a large and rapidly growing market.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS plans retrospective regulatory review.
Baxter International Inc. has scored a win from the U.S. FDA, which has granted the de novo application for Theranova, the company’s novel dialysis membrane. For his part, Cowen’s Josh Jennings noted that de novo designations are rare in the dialysis space, echoing a company statement. “We think the de novo classification strengthens any argument for the uniqueness of the technology, which should help its commercial experience,” he added. “BAX had expected an FDA clearance in [second half of] '20, so this action falls on the early end of that range.”
The U.S. FDA has granted emergency use authorizations (EUAs) to Baxter International Inc. for its HF20 Set and ST Set used in continuous renal replacement therapy (CRRT) during the COVID-19 pandemic. The two sets are intended for use with the company’s Prismaflex or Prismax CRRT monitors.
While the U.S. and other countries are looking to step up their own domestic drug and device manufacturing, a bigger takeaway from the COVID-19 pandemic is the need for resilient supply chains that can withstand a global scramble for products suddenly more in demand than the supply can support.
While the U.S. and other countries are looking to step up their own domestic drug and device manufacturing, a bigger takeaway from the COVID-19 pandemic is the need for resilient supply chains that can withstand a global scramble for products suddenly more in demand than the supply can support.
TORONTO – The Toraymyxin (PMX) hemoperfusion cartridge developed by Toronto’s Spectral Medical Inc. and used successfully to treat patients during the avian and swine flu pandemics is being eyed to help COVID-19 patients in Canada. Specifically, an emergency interim order from Health Canada expands its use to include treatment of COVID-19 patients with high levels of endotoxin in their blood and in acute respiratory failure.
Baxter International Inc., of Deerfield, Ill., has entered an agreement to acquire Seprafilm adhesion barrier and related assets from Paris-based Sanofi SA.
Baxter International Inc., of Deerfield, Ill., has entered an agreement to acquire Seprafilm adhesion barrier and related assets from Paris-based Sanofi SA. The expected price at closing is $350 million, with the transaction anticipated to wrap up in the first quarter of 2020.
Baxter International Inc. has struck a definitive agreement to acquire Cheetah Medical Inc., a provider of noninvasive hemodynamic monitoring technologies. The Deerfield, Ill.-based company agreed to pay $190 million up front in cash, with the potential for an additional $40 million based on clinical and commercial milestones.
