Medical Devices Today

FDA To Survey Clinicians About Adding “Highlights” Section To Device Labeling

Article preview from "The Gray Sheet"-  July 30, 2012

FDA wants to know what information physicians, nurses and technicians would like to see in a shortened "quick guide" version of labeling as part of an effort that could result in more standardized device labeling.

Sonitus Continues Climb Toward Reimbursement With Series D

Article preview from Start-Up - June, 2012

Early last year, Sonitus Medical obtained 510(k) notification for its non-surgical hearing assistance device to be used in patients with single-sided deafness. The culmination of five years of work, the FDA clearance positioned Sonitus to compete in, and company officials hope ultimately to expand, the $100 million market for devices for conductive hearing loss. But to do that effectively, the company still needs to convince Centers for Medicaid and Medicare Services and private payors.

Hernia Repair: No Simple Solution

Article preview from Medtech Insight - July, 2012

Hernia repair is a staple of the general surgeon’s practice, with more than two million procedures performed annually worldwide. However, the procedure has proven problematic due to the mesh products used to repair the hernia defect and their potential to cause complications over time. At the Fifth International Hernia Congress, held recently in New York City, physicians debated the pros and cons of the many hernia repair mesh products that are now available.

The Renal Denervation Buzz: Separating Fact From Myth; Covidien Buys Maya Medical

Article preview from IN VIVO - June, 2012

Renal denervation was clearly the belle of this year’s EuroPCR, with more than a dozen sessions on the topic. In addition, just preceding the meeting, Covidien announced its acquisition of RDN start-up Maya Medical.

Pressure Mounts On FDA After Public Release Of Surveillance Documents

Article preview from "The Gray Sheet"-  July 23, 2012

Multiple investigations and lawsuits have opened in response to the matter, with more potentially to come. Some worry the intensifying issue has serious implications for the quality of the device center’s output.

START-UP’s 2012 Medical Device Census

Article preview from Start-Up - June, 2012

Our data-driven review of the portfolios of more than two dozen leading medical device VCs show that the median life span of venture-backed companies hovers at seven years. Younger medtech companies are getting by – and getting farther in the regulatory process – with less capital, reflecting the current state of an industry that sees a whole lot of belt tightening in its future.

Device Connectivity Is Key To Health Care IT Revolution

Article preview from Medtech Insight - July, 2012

The ability to create and maintain a data stream of information that flows from medical devices into electronic health records (EHRs) is starting to become an important priority for some of the nation’s hospitals. The development is a natural outgrowth of the movement toward having a viable EHR for every patient, as well as the understanding that quality of care can be enhanced if those EHRs are fed the type of data that comes from devices such as ventilators, infusion pumps, anesthesia machines, and products that measure patient vital signs. That need is creating a new, niche market for companies that offer connectivity solutions, and at some point, these changes are predicted to alter the way hospitals choose which medical devices to purchase.

Device/Diagnostics Quarterly Deal Statistics, Q1 2012

Article preview from IN VIVO - June, 2012

Medical device companies raised $1.1 billion, a 40% increase over Q4 2011’s $800 million. Two billion-dollar deals in the resuscitation market boosted device acquisition activity to $4.2 billion. Twenty diagnostics financings brought in a collective $302 million, soaring above the previous quarter’s $269 million. There were seven diagnostics M&A deals completed, totaling $589 million – down yet again.

Radiation Oncologists Question Double-Digit Cuts To Medicare Physician Payments

Article preview from "The Gray Sheet"-  July 16, 2012

In its draft 2013 physician fee schedule issued July 6, CMS proposes an overall 14% decrease in reimbursement rates for radiation oncology therapy services based on new assumptions for intensity modulated radiation therapy and stereotactic body radiation therapy procedure times.

Where Device VCs Have Gone Before

Article preview from Start-Up - June, 2012

A deep dive of the portfolios of nearly three dozen device VCs shows that they’ve invested in certain therapeutic categories in the past including ophthalmic, cardiovascular, metabolic disease and spine. Like digging through soil to determine the climate conditions of eons past, the totals tell more about where the VC industry has been rather than where it’s going. But the past is sometimes of good indicator of what’s to come in both life and venture capital.