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.
As med tech companies explore innovative patient-monitoring technologies to meet growing demand, Swiss researchers are developing a miniaturized microfluidic device that would allow healthcare workers to monitor critical blood levels in real time in intensive care units.
Google is good at getting what it wants, as evidenced by its recent deals with device and biotech companies through its fast-growing Life Science group. And the tech titan’s allure has also attracted some of the industry’s top scientists, who left their positions in the research and academic fields to further Google’s med tech ambitions.
As researchers zero in on low-cost diagnostics for developing countries, a team of scientists at Rice University nabbed funding from the Bill & Melinda Gates Foundation to develop a miniature plastic microscope for rural communities with a lack of healthcare infrastructure.
The fate of drug/device combination product makers often hinges on a key FDA decision: A review of the product through the rigorous drug pathway rather than the device pathway can scupper a company’s plans.