Some pumps used in end-stage heart failure caused a buildup of biological material that blocks blood flow from the device to the heart’s aorta. The FDA’s recall affects nearly 14,000 devices.
Category: fda
Ten Doctors on FDA Panel Reviewing Abbott Heart Device Had Financial Ties With Company
Most of the doctors the FDA tapped to advise it on an Abbott medical device had financial ties to the company. The FDA didn’t disclose the payments.
A New $16,000 Postpartum Depression Drug Is Here. How Will Insurers Handle It?
A pill form of an effective drug for postpartum depression hit the market in December, but most insurers do not yet have a policy on when or whether they will pay for it. The hurdles to obtain its predecessor medication have advocates worried.
Toxic Gas That Sterilizes Medical Devices Prompts Safety Rule Update
The Environmental Protection Agency is tightening regulation of ethylene oxide, a carcinogenic gas used to sterilize medical devices. The agency is trying to balance the interests of the health care industry supply chain with those of communities where the gas creates airborne health risks.
‘Behind the Times’: Washington Tries to Catch Up With AI’s Use in Health Care
Lawmakers and regulators are trying to understand how AI is changing health care and how it should be regulated. The industry fears overreach.
FDA’s Plan to Ban Hair Relaxer Chemical Called Too Little, Too Late
The FDA’s recent notice that it would move to ban formaldehyde in hair-straightening products comes more than a decade after researchers raised alarms about health risks. Scientists say a ban would still leave many dangerous chemicals in hair straighteners.
Ketamine Therapy for Mental Health a ‘Wild West’ for Doctors and Patients
Ketamine, approved by the FDA as an anesthetic in 1970, is emerging as a major alternative mental health treatment, and there are now more than 500 ketamine clinics around the country. But with little regulation and widely varying treatment protocols, it’s a medical “wild West.”
Patients With Narcolepsy Face a Dual Nightmare of Medication Shortages and Stigma
It’s been more than a year since the FDA declared a national shortage of Adderall, and it’s affecting more than just patients with ADHD. Those with narcolepsy, a much rarer condition, are often treated with the same medication. Without it, they’re often unable to drive or function as usual.
‘AGGA’ Inventor Testifies His Dental Device Was Not Meant for TMJ or Sleep Apnea
The FDA and Department of Justice are investigating the Anterior Growth Guidance Appliance, or “AGGA.” TMJ and sleep apnea patients have filed lawsuits alleging the device harmed them. Its inventor now says the AGGA was never meant for these ailments.
‘AGGA’ Inventor Testifies His Dental Device Was Not Meant for TMJ or Sleep Apnea
The FDA and Department of Justice are investigating the Anterior Growth Guidance Appliance, or “AGGA.” TMJ and sleep apnea patients have filed lawsuits alleging the device harmed them. Its inventor now says the AGGA was never meant for these ailments.
