Minimally disruptive spinal implant specialist NuVasive is slated to build-out a new medical device manufacturing facility. The company expects to select a site by the end this year, with the expectation that the new facility will be up and running by the end of 2016.
Insightra Medical has raised $5 million to back its Freedom Octomesh Ventral Hernia System that was cleared by the FDA in May. The Octomesh implant has 8 integrated, radiating arms that are tunneled through the abdominal muscles. This is thought to more effectively hold the implant in place without the need for sutures or hernia tackers, which are suspected culprits in causing post-operative pain.
As companies such as Boston Scientific, Johnson & Johnson and C.R. Bard continue to face claims over allegedly defective vaginal mesh devices, new evidence is mounting against an industry that profits off women undergoing surgeries to remove the implants.
Investors already have priced in some high expectations into pain neurostimulator player Nevro. Just a few months into the launch of its first product, Senza, which is seen as a best-in-class product that will dominate the roughly $1.2 billion annual U.S. pain spinal cord stimulation market, Nevro is already worth a whopping $1.4 billion.
C.R. Bard has settled 3,000 cases by women injured from its vaginal mesh for more than $200 million. This is the latest in a parade of large settlements in recent months over the implants, which are said to cause pain and internal damage, from the likes of Endo International, Medtronic, Boston Scientific and Johnson & Johnson.
Hospital operator OhioHealth is going to bar contracts with physician-owned distributorships by the fall.
Abbott will buy two mitral valve replacement startups, moving it even further into med tech after a series of high-profile deals last year. It obviously sees the sector as a way for it to plan for long-term growth--since its innovative biopharma candidates went with AbbVie when the companies split in early 2013.
Edwards Lifesciences bumped up its transcatheter heart valve sales estimate for 2015 due to what it anticipates will be a strong U.S. launch for its third-generation TAVR device, Sapien 3. It was approved in June within a day of an FDA approval for a similar device from Medtronic, so the next quarter's earnings will start to tell the tale on how that U.S. next-gen TAVR competition will play out.
A titanium rod implanted inside a bone can improve limb-lengthening procedures that are used to prevent the need for limb amputation, a study in the journal Clinical Orthopaedics and Related Research co-published by Loyola University orthopedic surgeon Dr. Mitchell Bernstein found.
The U.S. Food and Drug Administration has approved an option for patients who have trouble with the standard socket leg prosthetics that are typically used for those with above-the-knee amputation. The implantable prosthetic requires two surgeries, but it's intended to encourage prosthetic usage and to improve patient outcomes.