The FDA grants de novo clearance to HeartFlow's novel system for non-invasive measurement of fractional flow reserve, which CEO Dr. John Stevens calls "the gold standard" for diagnosing and treating coronary disease.
Europe's top court today opened the door to stem cell patents in the European Union, ruling that an organism incapable of developing into a human is not an embryo and may be patented.
(Reuters) — Europe's top court today opened the door to certain stem cell patents in the European Union by ruling that an organism incapable of developing into a human being is not a human embryo and may be patented.
Here's a look at some of the top Wall Street stories for medical device companies this week: Year in review: 2014 was the year of the medtech IPO; Symmetry Medical closes surgical spinout, OEM sale; Inogen affirms 2014 outlook, predicts 2015 growth of up to 25%
The FDA warns consumers about the health risks of so-called "keepsake" fetal ultrasound imaging and over-the-counter fetal heartbeat monitors.
The FDA wants to dissuade expecting parents from using unregulated fetal ultrasound devices to create "keepsake" images or monitor their babies' heartbeats at home, warning that the devices pose serious risks in untrained hands.
Vector is Children's Hospital Boston's blog about research and innovation in pediatric and adult medicine. We report and comment on medical innovations and advances – from bench to bedside – touching on scientific, business and policy issues. Our ranks include science writers, physicians, lab researchers, market analysts and others inside and outside the hospital.
Researchers discovered many small nuances in pluripotency states of stem cells by subjecting the cells to various perturbations and then analyzing each individual cell to observe all the different reactions to developmental cues within a stem cell colony. (Credit: Wyss Institute at Harvard University)
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.