Medical Devices Today

Device Investing in Tough Times: The Venture View

Article perview reprinted from IN VIVO - July/August 2009

Device deals--albeit fewer--are still getting done in the current environment, and many investors remain bullish on devices. A panel of venture investors--both VC and corporate--who are still active dealmakers, discuss what they want to see today in start-up companies, and whether the device investment model has changed both for now and the future. Read more...

Becton Dickinson, J&J Catch Eye Of Closely Watched U.S. Investor

• Angiotech Wins Brazil Approval For Quill Suture Products
• CooperVision To Cut 570 U.S. Jobs, Spread Lens Production Abroad
• Edwards Lifesciences Looks To Utah For Expansion Sites
• Abbott To Expand Huge Angioplasty Study With Competitor Help
• Siemens, GE, Royal Philips Seen Taking Brunt Of Health-Reform Cuts
• Smith & Nephew Knee-Repair Plugs Obviate Transplant Procedure
• Abbott, Roche Diabetes Test Strips Draw New FDA Warning
• Masimo Lowers Expectations As Hospitals Cut Device-Buying Costs
• Wright Medical Launches New Device For Non-Invasive Foot Surgery
• Becton Dickinson, J&J Catch Eye Of Closely Watched U.S. Investor
• Medtronic Spends $1 Million Lobbying Congress In Three-Month Period
• Respironics, Royal Philips Sleep Devices Seen Having Greater Importance
• J&J Gets Unanimous Backing Of FDA Panel For Hip Replacement Device
• St. Jude To Cut 200 U.S. Jobs To Reduce Growing Expenses

invendo medical GMBH

Article preview reprinted from Start-Up - July 2009

invendo medical has crystallized its mission around solving not just the single issue of sedationless colonoscopy, which is regarded by some as the solution to getting more patients into the endoscopy suite for colorectal cancer screening, but all three of what the company characterizes as the major drawbacks of colonoscopy: 1) patient discomfort (triggering the costs and complications of sedation); 2) the ease-of-use issue, or rather, the challenging learning curve of conventional endoscopes; and 3) the reusability that leads to cumbersome cleaning routines and residual infection risk. Invendo has developed a non-push scope that drives itself under the operator's control. Read more...

Supreme Court Case Could Narrow Patent Eligibility For Diagnostics

Article perview reprinted from "The Gray Sheet" - August 17, 2009

The medical device industry is asking the Supreme Court to overturn a Federal Circuit court decision that could exclude some diagnostics from patent eligibility.

FDA Begins Review Of Pre-amendments Device Data Submissions

Article perview reprinted from "The Gray Sheet" - August 17, 2009

A friendly reminder to pre-amendments device makers: failing to submit the safety and effectiveness information FDA ordered on 25 device types this April could result in seizure, injunction or even criminal prosecution. Read More...

FDA Will Move Faster To Ban Bad Actors From Clinical Trials

Article perview reprinted from "The Gray Sheet" - August 17, 2009

Recent changes will speed FDA's process for barring non-compliant clinical trial investigators from future product research, agency staffers say.

Medical Device User Fees And Guidance - FY 2010

Full device user fee chart and guidance reprinted from "The Gray Sheet" - August 10, 2009

Medical Device User Fees and Guidance - FY 2010 - DOWNLOAD THE FREE 40-PAGE PDF

FDA published its fiscal year 2010 fees for pre-market submissions and other regulatory filings Aug. 3, plus guidance for small businesses in the U.S. and abroad with updated certification instructions. The new fees reflect an across-the-board 8.5% increase over fiscal 2009, in accordance with the FDA Amendments Act of 2007. The rates apply from Oct. 1, 2009, through Sept. 30, 2010.

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BeneChill raises $13.5mm through Series C round

Deal summary reprinted from Strategic Transactions - July 2009

BeneChill (therapeutic hypothermia-inducing device) has raised $13.5mm through its Series C venture round. New backer HealthCap led the financing and contributes a board member. Returning shareholders MedVenture Associates, NGN Capital, and the Solon Foundation also participated. Read more...

Hear China & India Case Studies From Industry Leaders

Early-Bird Discount For PharmAsia Summit Expires Aug. 31

As pharma looks to broaden its capabilities beyond its four walls and spread the risk and rewards of drug development, companies are looking east to the multi-billion dollar Asian market, especially emerging markets like China and India. Read more...

Scoping out Gastroenterology Start-Ups

Article preview reprinted from Start-Up - July 2009

The field of gastroenterology is tantalizing for device manufacturers because it offers one of the rare screening paradigms in medicine, and therefore, enormous markets. In the US, it's recommended that everyone over the age of 50 be screened for colorectal cancer by a colonoscopy procedure. However, compliance with colorectal screening recommendations is low, less than 50% for colonoscopy, the gold standard for detecting precancerous polyps. GI endoscopy is unusual among screening paradigms in its degree of invasiveness and cost, and that limits access to screening. Medtech start-ups hope to improve upon this state of affairs by offering new technologies to improve the ease, decrease the discomfort, and increase the efficiency of endoscopic procedures. Read more...