The FDA is moving at two speeds in the medical device approval process. On the one hand, the agency is taking a critical look at the 510(k), expedited approval process, which has come under fire for being too lenient. The process will certainly see some change, given the pressure ensuing from high profile device failures [...]
FDA Approves For Permanent Treatment Of Advanced Heart Failure Assist Device Pioneered By Texas Heart Institute At St. Luke’s Episcopal Hospital. See Link
Although designed as a bridge-to-transplant device, the HeartMate II has proven itself sufficiently in trials to warrant its approval as a permanent device. Designed by the Texas Heart Institute, the continuous flow left ventricular [...]
The number of companies with approved products and measurable revenues in the field of cell therapy and tissue engineering has exceeded the expectation of many (though not all) in the industry.
Markets such as cell/tissue are often characterized by overestimated evaluations of commercial potential and underestimated consideration of the actual challenges. Indeed many technology challenges remain [...]
With the FDA's approval of Medtronic's Melody Transcatheter Pulmonary Valve and Ensemble Delivery System (see link), another step has been made toward eliminating traditional surgery — at least that's the idea. The ability to implant a valve via a percutaneous procedure advances the art of less invasive intervention in ways akin to laparoscopic surgery, albeit at [...]
As an exercise, I found it worthwhile to map out the various options available or under development for the treatment of coronary artery disease.
We assess the emphasis of current, near-term and future possible options for treatment in the color-coded scheme:
Bold, black: Current, dominant treatment options
Green: Near term options with potential to gain significant caseload
Red: Long-term [...]
The areas of greatest opportunity in medtech are those which have already demonstrated they have plenty of upside, even if a robust number of competitors have already begun targeting them.
Areas of the strongest market growth in medical technologies that we are seeing have emerged out of the major segments we have tracked in recent analyses. [...]
The development of less invasive surgical procedures continues to move toward procedures that may be "incisionless" or only require small perforations to accommodate surgical tools. Principal among approaches that are under evaluation are NOTES procedures — Natural Orifice Transluminal Endoscopic Surgery — in which access is provided endoscopically via the mouth or vagina.
NOTES has recently [...]
Medical technology startup companies that we identified during the month of October 2009 are developing the following specific technologies:
Diagnostic imaging in urology and oncology.
Endoscopic tissue management technology.
Esophageal monitoring device to replace peripheral artery catheter.
Products for treatment of fecal incontinence and GERD.
Surgical instrumentation to reduce trauma of surgery.
Suction device for use in sleep breathing disorders.
Fully absorbable [...]
This is a "work in progress", partial list of medical technology incubators, defined as such by themselves or by the nature of their more active involvement (beyond funding) in the nuturing and development of "portfolio" companies — providing space, management and other support. Also, note that these are entities whose focus is primarily or exclusively [...]
CryoLife's BioFoam, a protein hydrogel, received FDA approval today to begin an IDE for sealing of liver parenchymal tissue when conventional methods (e.g., ligature) prove ineffective.
The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent. The feasibility investigation will be conducted [...]
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