The FDA is alerting the public that rare cases of underactive thyroid were reported in babies who were given iodine-containing contrast agents for X-rays and other medical imaging procedures.
FDA is calling for more oversight of lab-developed tests (LDTs) in the wake of a congressional hearing about the agency’s ability to regulate the products, pointing to a new internal report that says certain LDTs “may have caused or have caused” harm to patients by producing incorrect results.
Companies are developing innovative devices for medical marijuana, rolling out everything from palm-sized inhalers to metered products that deliver drugs through the inner cheek. Massachusetts startup CannaKorp is taking a different approach, creating a Keurig-like medical marijuana vaporizer device to compete for its share in a growing market.
As researchers explore innovative tools for diabetes monitoring, scientists in Mexico are developing a smartphone-based device that can measure glucose in the blood by analyzing urine in the toilet.
At least in the device world, the potential for a malicious, targeted, even fatal cyberattack against a patient’s infusion pump or other device is well known, thanks to the efforts of “white hat” hackers like Billy Rios. Less talked about are ongoing nefarious cyberattacks against devices intended to steal private medical information.
The FDA is pushing device manufacturers to go beyond meeting baseline regulatory guidelines through its Case for Quality initiative, the head of the FDA’s device arm (CDRH), Dr. Jeffrey Shuren, wrote in a post on the agency’s blog.
Apple has dealt with setbacks for its Apple Watch since rolling out the product earlier in 2015, shelving certain health features prior to launch and facing complaints over the accuracy of the device’s heart rate monitor. With its med tech aspirations for the watch on the back burner, some analysts think the company could turn to corporate markets to boost sales for the product.
In a sure sign of recovery from a famous setback dealt by the FDA, Anne Wojcicki promised she will not sell her once again trendy diagnostics company 23andMe.
As scientists search for lighter, low-cost alternatives to traditional imaging tools such as MRI or CT scans, engineers at Stanford University are developing a device that uses microwaves and ultrasound to pinpoint targets without touch, potentially improving tumor detection.
The FDA is cracking down on direct-to-consumer testing companies including DNA4Life and Interleukin Genetics for selling their tests without proper approval, a few weeks after the Agency cleared the way for 23andMe to proceed with its DTC genetic reporting service.