The agency's list focuses on coronavirus diagnostics impacted by S-gene dropout, an occurrence that is most commonly associated with Thermo Fisher Scientific's TaqPath test kits.
The American Clinical Laboratory Association wants lawmakers to push off 2022 cuts for nearly 600 lab tests. A stopgap bill late last week did not include a reprieve, but Cowen analysts are optimistic a legislative fix will be found.
The agency granted regulatory privileges to therapies for lung cancer and bone metastases from RefleXion Medical and Zetagen Therapeutics, respectively.
The insulin pump maker expects to triple its installed units over the next five years behind new product launches and capturing market share as use among Type 1 and Type 2 patients is projected to take off.
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