Casi todos los estadounidenses con marcapasos -y personas en todo el mundo- caminan portando partes fabricadas en Tijuana, México, en donde se ha creado una industria que podría estar en riesgo si la administración Trump cambia el juego del comercio global.
The medical supply industry makes a particularly revelatory case study of the difficulties of untangling global trade.
A new study, though small, finds extensive damage to commonly used medical scopes that could trap dangerous bacteria. That raises concerns about the potential for more outbreaks.
The FDA and other agencies are loosening restrictions on hearing aid sales and opening the door to less expensive, over-the-counter products.
Lawyers who deposed top company officials in a civil case say they declined to answer questions about their failure to warn American hospitals of infection risks. Industry giant Olympus also is the subject of a criminal probe.
Small manufacturers are betting that disposable medical scopes will slash the risk of infection during procedures. Some doctors are skeptical of the cheaper models.
The federal agency took 14 months to warn the public about the potential for infections. Officials say they acted as fast as they could.
Why an obscure revenue raiser for the Affordable Care Act has found its way into a number of congressional campaign ads.
The agency found several prominent facilities had not followed rules on reporting incidents in which patients were harmed.
The FDA confirms it is looking into more than one problem with the compressor, which is used to power patients’ artificial hearts.
High-intensity focused ultrasound, often not covered by insurance, leads to discussions about which patients benefit in the real world.
The drug’s manufacturer says it has an expiration date of 12 to 18 months but that includes distribution time, so many customers find they have to buy a new device at least once a year.
A closer look shows that industry lobbying was just one factor in EpiPen’s sales explosion.
In a small study, Minnesota researchers found that the infant drops used to increase visibility during procedures may create a “perfect habitat” for bacteria and make scopes harder to clean.
Two Los Angeles area patients alleged a prominent UCLA spine surgeon harmed them by using Medtronic devices in experimental ways without their consent and failing to disclose his financial ties to the company. Both UCLA and Medtronic deny wrongdoing.
U.S. Rep. Ted Lieu (D-Calif.) renews his call for tightened laws that would force manufacturers to notify the Food and Drug Administration when they issue safety warnings in other countries related to the design and cleaning of their devices.
Newly released court documents show that after Tokyo-based Olympus Corp. alerted customers in Europe in 2013, it told its U.S. operation not to warn U.S. doctors and hospitals. Since then, at least 35 patients have died after being sickened in outbreaks.
After a wave of sometimes-deadly superbug infections, the agency last year ordered a recall of Custom Ultrasonics machines used to disinfect medical scopes. Now, with little explanation, it is backing off.
House panel concludes inquiry on superbug outbreaks; one member prepares legislation “to make sure these situations don’t happen again.”
The device manufacturer had a close relationship with Ronald Reagan UCLA Medical Center in Los Angeles — until its scopes were linked to infections and the company raised the price for new ones by 28 percent.