Commercial Operations


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

Michigan Court Allows State Fraud Claim Against Medtronic to Continue

A Michigan district court judge ruled last week that product liability claims against an FDA-approved medical device manufacturer were preempted by federal law and dismissed them, but did allow part of the fraud claim against manufacturer Medtronic to proceed at the state level. Read More

AHCA Includes Permanent Medical Device Tax Repeal

The House approved a health care bill Thursday that includes a one-line provision to repeal the medical device excise tax as of Dec. 31, 2017. Read More

New Survey Bullish on U.S., EU Device Markets

Medical device manufacturers expect strong sales growth in the U.S. and Europe this year but they are less enthusiastic about China and other developing markets. Read More

Chaffetz Vows Subpoena if Mylan Foot-Dragging Continues

The House Oversight Committee threatened to subpoena Mylan for full documents related to price increases for its EpiPen. Read More

Grassley Presses CMS for Records, Answers on Mylan

Sen. Charles Grassley (R-Iowa) put pressure on the Centers for Medicare and Medicaid Service to release records on Mylan’s classification of the epinephrine auto-injector the EpiPen for Medicaid. Read More