Inspectors identify violations at the Becton Dickinson site in New Jersey but allow tubes at the center of the investigation to stay on the market.
The failure to stop the tax means manufacturers must report sales to the IRS and pay 2.3% on revenues generated by products covered by the levy.
In looking ahead, we have picked two of the ways companies are working to change healthcare and the cybercrime fly in the ointment for analysis.
In 2017, abstract fears about the security of healthcare technologies solidified into a concrete threat.
Biom’Up said the FDA signed off on marketing its Hemoblast Bellows hemostatic product designed to control bleeding during surgery.
The AHA is critical of how medical device manufacturers managed the WannaCry threat and wants the FDA to step in.
StoneChecker, a U.K.-based medical software developer, said it has received a CE Mark for its software that analyzes kidney stones.
The FDA is set to exempt some software from oversight as it reconsiders regulation of products on the fringes of the medical device sector.
The 510(k) clearance sets Merck up to make the device available to IVF clinics in the first half of next year.
In a much-anticipated action, the FDA released its first-ever technical guidance for manufacturers using 3D-printed technology for medical products that…