Medical Devices Today

Alzheimers Dx: An Essential Piece of the Puzzle

Article preview from Medtech Insight - February 1, 2011

Finding growth opportunities in an era of constrained spending and health care reform is not an easy task, but an increasing number of companies operating in the diagnostics space are taking aim at one underserved area they believe will be a big winner in the years ahead: Alzheimer's disease. This is a field still in its infancy and the risk of failure remains high. But as research progresses, it's becoming clear that advances in AD diagnostics could play a major role in reducing that risk.

Diagnostics For All Set To Take The Field For Clinical Trials

Article preview from Start-Up - February 2011

Not-for-profit start-up Diagnostics for All is set to begin a field trial in Kenya in March to evaluate a postage stamp-sized disposable diagnostic device to assess liver function in AIDS and TB patients. But the company eschews the notion that it's a charitable endeavor. Rather, it has crafted a licensing deal and business model that anticipates leveraging its not-for-profit work into a sustainable commercial First World business.

Parallel FDA/CMS Review Is Poised for Prime Time - But Is Anybody Biting?

Article preview from IN VIVO - February 1, 2011

The device industry has long complained about the lengthy, separate review times required to achieve FDA and CMS clearance. Finally, the two agencies are working together on a pilot program to make this process faster and more efficient. Industry's response: not so fast. Despite the apparent advantages parallel review can offer to product companies, industry has been cautious and slow to respond out of concern for protecting proprietary data and the possible need for more complex clinical studies.

When To Tell Investors Of Adverse Events? It Depends, Says Supreme Court

Article preview from "The Gray Sheet"- March 28, 2011

A March 22 Supreme Court ruling puts more onus on device makers to establish a defensible policy for determining which adverse events investors need to know about.

Radiosurgery Branches Out

Article preview from Medtech Insight - February 1, 2011

The convergence of advancing technology and the push for more effective, noninvasive cancer treatments is helping to build the perfect storm of innovation for the field of stereotactic radiosurgery. SRS allows high doses of precisely focused ablative energy to be delivered to targeted tissues with a minimum of damage to surrounding areas. It has been used for years to treat tumors in the head and neck, where patient movement can be effectively restrained with frames to protect healthy tissue.

NinePoint Medical Inc.

Article preview from Start-Up - February 2011

Over the past 20 years, the diagnosis of esophageal adenocarcinoma - the most common form of esophageal cancer - has doubled in the US and now stands at roughly 16,500 new cases each year. This dramatic increase is believed to be related to an increased incidence of gastroesophageal reflux disease (GERD) and obesity.

Alphatec: Betting On the Aging Spine

Article preview from IN VIVO - February 1, 2011

Once a small manufacturer of custom products, Alphatec was acquired by HealthpointCapital in 2005 with the goal of turning the company into a major player in spine. Alphatec's strategy has been to target important new technology areas, such as minimally invasive surgery and biologics, with a special focus on elderly patients and the specific problems they face.

Innovation Efforts Offer A Way To Change FDA's Views On Risk, Industry Says

Article preview from "The Gray Sheet"-  March 21, 2011

FDA should put more emphasis on product benefits and patients' willingness to take on risk in pre-market reviews of particularly innovative devices, industry participants argued during an agency workshop last week.

 

Sepsis: A Market in Need

Article preview from Medtech Insight - February 1, 2011

In this era of health care reform, critical care medicine remains a strong market for innovative technologies that can improve patient outcomes, shorten ICU stays, and ultimately reduce the overall cost of care. Within this space, one segment that is ripe for innovation is the market for severe sepsis products.Although the last 20 years have seen advances in treatment and a marked increase in the understanding of sepsis and septic shock, severe sepsis remains one of the most significant challenges in critical care today.

Pulmonary Device Companies Take It To The Streets - In Europe

Article preview from Start-Up - February 2011

For the past decade, venture capitalists have invested in companies that are developing new technologies to treat late-stage chronic obstructive pulmonary disorders.Despite hundreds of millions in venture capital dollars, the companies have made little progress in bringing these products to market in the US. But this band of start-ups is taking the fight to the streets - of Europe.