CerviLenz (Chagrin Falls, Ohio), a woman's health device company in the Cleveland area, has recently bumped its Series A round of investment up to $8.35 million, thanks to a recent tranche of funding from existing investors.

The FDA's long-awaited approval for the transfemoral delivery of Edwards Lifesciences' (Irvine, California) Sapien transcatheter aortic heart valve is a fitting example of the old adage "good things come to those who wait." This represents the first artificial heart valve that can replace an aortic heart valve damaged by senile aortic valve stenosis without open-heart surgery, FDA noted.

Cyberonics (Houston) said the FDA has approved a significant expansion of options for MRI use by patients who have the company's VNS Therapy System, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression.

Resistant hypertension has plagued cardiologists and their patients who suffer from high blood pressure that does not respond to drugs or lifestyle changes for years. But hope is on the horizon. Two major medical device companies reported efforts last month to develop renal denervation devices for resistant hypertension and now Rox Medical (San Clemente, California) has reported the first clinical use of a small metallic stent-like implant aimed at the problem.

Five years ago this month my byline began appearing on the pages of Medical Device Daily. When I first joined the MDD staff in October 2006 I knew very little about this industry. It was like moving to a new country where the language, culture, and rules were completely foreign to me. I was concerned, at first, that my lack of a medical or scientific background would hinder my ability to cover the space adequately. But I learned quickly and before I knew it I was well-versed on the differences between a drug-eluting stent and its bare-metal cousin, the pathway...

Medtronic (Minneapolis) reported the start of SYMPLICITY HTN-3, the U.S. trial of its Symplicity renal denervation system for treatment-resistant hypertension. The first patient in this landmark study was enrolled at the Prairie Heart Institute at St. John's Hospital (Springfield, Illinois).