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.
Industry and the FDA are striving toward faster approval times counterbalanced by increased postmarket monitoring as they aim to optimize med tech regulation.
Using stem cells to treat traumatic brain injury is thought to be promising, but delivering those cells via an injection into the central nervous system is fraught with risk including intracranial hemorrhage and the simple failure of the cells to reach the correct area of the brain.
Researchers have developed an epidermal electronic device that can monitor skin health and blood flow that is easier and less expensive to use than other noninvasive sensors relying on optical or ultrasound technology.
Under a blockbuster legal settlement, more than 450 hospitals in 43 states have agreed to pay the Department of Justice more than $250 million for installing implantable defibrillators within 40 days of a heart attack or 90 days of bypass surgery or angioplasty–a violation of Medicare reimbursement protocol.