Medical Devices Today

RESPECT And PC Trial Results In, But Still No Real ‘Closure’ On PFO

Article preview from "The Gray Sheet" - October 29, 2012

There was some expectation leading up to TCT that the two trials could provide a definitive ruling on whether the PFO closure procedure had a future or not. But actual outcomes sparked a range of interpretations.

In Europe, Contrarian VC Wellington Partners Favors Medical Devices

Article preview from Start-Up - October, 2012

In September, Wellington Partners announced that it closed on €70 million ($91 million) in new venture capital, the first commitment for a fund devoted to life science investing. The target size of Wellington Partners IV Life Science Fund is €120 million, a significant increase over its previous fund devoted to the life sciences, which raised €78 million. Five years ago, this event wouldn’t even have been news, but in a world where venture capital funds are generally contracting, and specifically with regard to life sciences, Wellington offers medical device start-ups a bright spot of hope.

Huge Markets For Devices Emerging In Brazil, Latin America

Article preview from IN VIVO - October, 2012 

Nearly stalled Western economies have driven corporations of all stripes to ponder the market potential promised by the so-called BRIC countries (Brazil, Russia, India and China). The medical device industry is no exception. The BRIC nations present a challenging but lucrative opportunity for companies willing to deviate from traditional markets to access economies with GDPs that place them in the top 15 economies in the world. Of the BRIC nations, China has become the number one destination for health care technology companies in the minds of CEOs of commercial-stage medical device companies. But executives staring only on China might be missing another compelling opportunity that literally rests under their noses: Latin America.

 

Femtosecond Lasers: Expanding The Premium Cataract Surgery Market

Article preview from Medtech Insight - September, 2012

When femtosecond lasers for cataract surgery hit the market in early 2011, it was apparent that that they would bring unprecedented precision to the procedure. The key questions surrounding this emerging field quickly shifted to commercial viability: how would US cataract surgeons and facilities be able to pay for this expensive new technology in a procedure that is reimbursed almost entirely by Medicare, and therefore subject to strict billing limitations? A survey of early laser adopters in the US, detailed below, suggests that surgeons are successfully navigating these regulatory hurdles and incorporating the new lasers into their practices.

Device Companies Follow New Map To Atrial Fibrillation

Article preview from Start-Up - October, 2012

Three years ago, the FDA approved Johnson & Johnson’s ThermoCool, the first in a series of ablation catheters specifically designed to halt atrial fibrillation. Despite these advances, the long-term success rates of catheter ablation procedures remain low, opening the door for start-ups to devise new approaches.

Medtech Investing In Europe: Nowhere To Go But Up

Article preview from IN VIVO - October, 2012 

Even as the rest of the global economy seems somewhat on a path to recovery, medtech-focused VCs, in the US at least, are experiencing a time of significant uncertainty and attrition: fewer dollars available for new investments, a trend away from early-stage deals, and fewer and smaller venture firms overseeing smaller new funds. For European medtech investors, there has been little of the gloom and uncertainty that the US venture capital community has experienced over the past several years, if only because there was no pre-bust bubble from which to fall.

Molecular Diagnostics Ushers In New Era Of Prenatal Testing

Article preview from Medtech Insight - September, 2012

The recent launch of several noninvasive gene-based tests for Down syndrome and other fetal chromosomal abnormalities is poised to upend current prenatal screening practices and potentially usher in a new, multibillion-dollar market opportunity in the process. These new tests employ next-generation gene sequencing, along with advanced, risk-based computer algorithms, to detect and characterize fetal genetic abnormalities using the DNA present in a maternal blood sample. And because they are actually able to “interrogate” the DNA, they represent a huge technological advance over the current standard-of-care for prenatal screening.

CDRH Entrepreneurs Take Two: Streamlining Data Collection And The Path To Reimbursement

Article preview from "The Gray Sheet" - October 22, 2012

FDA’s device center launched the second round of its entrepreneurs-in-residence program, bringing in outside experts to the center to focus on streamlining data collection and the approval-to-reimbursement pathway.

Aspire Bariatrics Inc.

Article preview from Start-Up - September, 2012

An ideal minimally invasive bariatric technology should be safe, easily implantable, suitable as a permanent therapy, and allow patients to eat a normal diet. Aspire Bariatrics Inc. thinks its solution fits the bill. With the AspireAssist Aspiration Therapy System, patients have control over their weight loss as they are able, about 20 minutes after a meal, to drain a portion of their stomach contents through an endoscopically implanted tube, thus reducing the number of calories absorbed by the body.

 

Femtosecond Lasers: Expanding The Premium Cataract Surgery Market

Article preview from Medtech Insight - September, 2012

When femtosecond lasers for cataract surgery hit the market in early 2011, it was apparent that that they would bring unprecedented precision to the procedure. The key questions surrounding this emerging field quickly shifted to commercial viability: how would US cataract surgeons and facilities be able to pay for this expensive new technology in a procedure that is reimbursed almost entirely by Medicare, and therefore subject to strict billing limitations? A survey of early laser adopters in the US, detailed below, suggests that surgeons are successfully navigating these regulatory hurdles and incorporating the new lasers into their practices.