Lori A Carr

If you are still using FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date.

The Framingham Heart Study has revolutionized cardiology over the decades, leading to insights like the dangers of smoking in the 1960s, elevated blood pressure in the 1970s and more recently, genomic risk factors.  Another Massachusetts study is underway, with the intention of becoming the equivalent study in the orthopedics arena, according to Dr. David Ayers, chair of the orthopedics department at the University of Massachusetts Medical School in Worcester.

Google is divvying up its composite parts, becoming, depending on whom you ask, the new Berkshire Hathaway, the next General Electric or something heretofore never seen.  However, the move could have mixed implications for Google’s nascent but growing life sciences empire — including the high-profile, secretive biotech Calico–as shuffling things around could expose such moonshot projects to the pitchforks of profit-hungry investors.

Google has been scouting out promising med tech projects since launching its life sciences division a couple of years ago, inking deals to expand its reach in patient monitoring and wearable health.  In its latest foray the company will work with Dexcom to develop cheaper, miniaturized glucose monitors, combining its electronics platform with Dexcom’s sensor technology to improve care for patients.

Pennsylvania drugmaker Zynerba Pharmaceuticals is making its way to Wall Street with some cannabis-derived treatments for central nervous system disorders, raising $42 million in an IPO.

Brain-controlled prostheses are picking up steam within the industry, and a team of scientists from Stanford University is harnessing the technology to create a system that could help paralyzed patients carry out more precise movements.

As researchers target innovative technology geared toward military use, U.S. army scientists are developing a device that could monitor how long an individual is able to compensate for blood loss.

FDAs Center for Devices and Radiological Health (CDRH) issued a revised version of the guidance document “Refuse to Accept Policy for 510(k)s”

Spinal cord stimulation is the med tech trend du jour, and researchers are harnessing the technology to create a noninvasive method that helps restore movement in paralyzed individuals.

On a Monday in July 2015, the US Food and Drug Administration (FDA) released a draft guidance detailing how it plans to use quality metrics to improve its ability to conduct risk-based inspections and predict or mitigate potential drug shortages.