Medical Devices Today

FDA May Impose More "522" Studies As Post-Approval Enforcement Tool

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...

Device Firms Want Their Own Guidelines On Risk Information In Ads

Full article reprinted from "The Gray Sheet" - August 31, 2009

FDA's draft guidance on presentation of risk information in advertisements fails to adequately distinguish between devices and drugs, according to device trade group AdvaMed.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...

The Longest Journey: An Interview with Hira Thapliyal

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...

Single-Incision Laparoscopy: Boon or Bust?

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...

Medtronic, Boston Scientific, Others Spend $8 Million Lobbying

• 3M Unveils Electronic Stethoscope That Relays Sounds To Software
• Medtronic, Boston Scientific, Others Spend $8 Million Lobbying
• Boston Scientific Stents Fare Well In Pair of Studies
• Angiotech Launches Artery-Filtering Device To Prevent Lung Blockage
• Covidien To Get Medical Imaging Isotopes With Dutch Resumption
• Boston Sci Loses Appeal For St. Jude Damages For Foreign Sales
• GE Announces MRI Machine To Accommodate Claustrophobics, Obese
• Zimmer, DePuy, Biomet, Cook Weather Economic Storm In Indiana
• Medtronic Consultant Resigns As Head Of Orthopedic Group
• Abbott Sued By Inventor Who Won Stent Suit Over Boston Scientific
• Medtronic Earnings Hit Hard By Settlement Of Abbott Stent Dispute

Medicare Gainsharing Demos Still Have A Pulse, CMS Release Confirms

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...

Feds Seeking A Few Good Tests, And Masks, For Flu Season

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...

Electronic Adverse Event Reporting Would Be Mandatory Under FDA Proposal

Article perview reprinted from "The Gray Sheet" - August 24, 2009

Device manufacturers would have to submit adverse event reports to FDA electronically under a draft rule issued Aug. 20. Read more...

Why Medical Device Manufacturers’ Employee Training Programs Are Under FDA Scrutiny

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 brings in $18.5mm via Series F

Deal summary reprinted from Strategic Transactions - 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...