Article perview reprinted from"The Gray Sheet" - August 31, 2009
FDA says it will more frequently use its authority to mandate so-called Section 522 post-market studies when companies fail to meet their original post-approval study requirements - and this time, the idea might actually stick. Read more...
FDA's draft guidance on presentation of risk information in advertisements fails to adequately distinguish between devices and drugs, according to device trade group AdvaMed. Read more...
Article perview reprinted from IN VIVO - July/August 2009
Born in a remote village in India, Hira Thapliyal played a critical role in the creation of many early technologies used in interventional cardiology, including DVI's atherectomy device and CVIS' intravascular ultrasound. However, he's perhaps best known as one of the founders of ArthroCare. In this interview adapted from the Stanford BioDesign Program's Innovators Workbench series, Thapliyal looks back on his early career. Read more...
Article preview reprinted from Medtech Insight - July/August 2009
Medtech Insight -- One of the most recent trends in laparoscopic surgery is to access the peritoneal cavity via the umbilicus using a single skin incision. Single-incision laparoscopy introduces additional constraints to the conventional laparoscopic environment and requires surgeons to use new flexible and articulating instruments and novel access platforms. Over the past two years, medical device companies have been racing to develop enabling technologies for single-incision laparoscopy, but the approach is controversial and its future appears uncertain as surgeons debate the cost/benefits of the single-incision laparoscopic approach. Read more...
Article perview reprinted from"The Gray Sheet" - August 24, 2009
Two Medicare demonstration projects targeting the practice of hospital-physician gainsharing resurfaced in a CMS press release last week after a period of obscurity. Read more...
Article perview reprinted from"The Gray Sheet" - August 24, 2009
With an especially challenging flu season expected this year, government officials are scrambling to evaluate the tools they have available to monitor, diagnose and limit spread of the virus. Read more...
Elsevier Business Intelligence announces the publication of a new Special Report: Why Medical Device Manufacturers’ Employee Training Programs Are Under FDA Scrutiny. Originally published in "The Silver Sheet," Vol. 13, No. 8, August 2009
NiTi Surgical Solutions (developing surgical devices for colorectal, gastric, and upper gastrointestinal diseases) closed on its $18.5mm Series F financing led by first-time backer Forbion Capital Partners, which adds a board member. Returning shareholders Evergreen Venture Partners, Israel Healthcare Ventures, MBVC and Alice Lab (funds of Alice Ventures), and SCP Vitalife also participated. Read more...
