Commercial Operations


IV Bag Shortage Continues After Hurricane Maria Damage

The FDA continues to grapple with shortages of saline intravenous injection bags that were worsened when Hurricane Maria devastated Puerto Rico, and the agency is temporarily allowing the importation of bags to boost the supply, Commissioner Scott Gottlieb said. Read More

Gottlieb: Puerto Rico Device Firms Still Operating Below Capacity

Helping to restore medical manufacturing in Puerto Rico has been the “highest priority” at the FDA since hurricanes Maria and Irma struck, Commissioner Scott Gottlieb told a congressional committee on Oct. 24. Read More

Medical Device Firms in Puerto Rico Still in Recovery Mode

Devicemakers in Puerto Rico continue to grapple with the widespread destruction left by Hurricane Maria. Read More

AAMI Offers Devicemakers a Tool for Managing Service-Level Agreements

The Association for the Advancement of Medical Instrumentation released a service-level agreement template to help original equipment manufacturers and healthcare providers improve their working relationships. Read More

FDA Goal to Bring Puerto Rican Device Manufacturing Back Online

Following the destruction by Hurricane Maria in Puerto Rico, FDA Commissioner Scott Gottlieb said one of the agency’s main goals in the recovery effort is to bring the island’s medical product manufacturing plants back into operation. Read More

Abbott Halts Sales of Bioresorbable Vascular Stent

Abbott pulled its absorbable vascular scaffold Absorb from the market on Sep. 14, saying the product cost more to make than it earned. Read More

China Looks West for Boost to Medical Device Industry

Grace Fu Palma, founder and CEO of Boston-based China Med Device, LLC, a firm specializing in commercialization and funding for medtech companies entering China, considers CFDA’s proposal for exempting certain IVD reagents from clinical trials. Read More

Conservative Groups Ask Congress to Block Return of Medical Device Tax

Congress should permanently wipe out the suspended Affordable Care Act tax on medical devices scheduled to resume Jan. 1, a coalition… Read More

Senate’s ‘Skinny’ ACA Repeal Fails

The Republican effort to repeal the Affordable Care Act came to a halt in the Senate early Friday morning — with nays from Sens. Lisa Murkowski (R-Alaska), Susan Collins (R-Maine) and John McCain (R-Ariz.) — taking with it an extended moratorium on the device excise tax. Read More

South Africa’s Universal Health Coverage Will Benefit Devicemakers

South Africa’s Department of Health released its plan for a national universal healthcare system that will affect how medical devices are reimbursed. Devicemakers also are expected to benefit from the scheme as new regional clinics are built and medical equipment is purchased. Read More