The U.S. Food and Drug Administration has issued a safety communication regarding a wide array of intravascular implanted devices and delivery tools that have coatings designed to reduce friction and improve maneuverability.
Johnson & Johnson's Biosense Webster added to its antistroke offerings with the acquisition of Salt Lake City's Coherex Medical, maker of the CE-marked Coherex WaveCrest Left Atrial Appendage Occlusion System, for an undisclosed sum.
Reimbursement for sacroiliac joint fusion as a treatment for some kinds of lower back pain is becoming more common after it gained a reimbursement code at the start of this year, despite the procedure remaining somewhat controversial.
A few weeks ago, minimally invasive surgical startup SI-Bone announced that it had nabbed an expanded indication for its iFuse Implant System from the FDA. Now, the company has gained a $39.2 million credit facility from Oxford Finance and Silicon Valley Bank for $39.2 million to help market iFuse.
Medtronic has launched the first app-based remote monitoring for implantable pacemakers. Remote monitoring of pacemakers has been the standard of care, but this next-gen version goes beyond a dedicated device to do so.
Johnson's & Johnson's DePuy is launching a comprehensive program to optimize outpatient joint replacement at U.S. ambulatory surgical centers and outpatient hospitals that includes physician training, an educational video for patients to facilitate postoperative recovery and software for outcomes data collection, all in an effort to increase patient satisfaction by getting them home faster.
A surgically implanted artificial kidney under development at the University of California, San Francisco, has been accepted into the FDA's Expedited Access Pathway for "breakthrough" technologies that debuted just 6 months ago.
Minneapolis-based Cardionomic spun out of the Cleveland Clinic and into NEA's Denali II incubator. Now, it's graduated to a $20 million round backed by those two, as well as strategic investor Greatbatch--which is in the process of spinning out its own neurostimulation business.
Reseachers at Carnegie Mellon have hacked a sub-$3K consumer 3-D printer to create biological-material models of embryonic hearts, arteries, bones and even human brain tissue. The hope is that this work could lead to tissue creation that is adequate to repair soft tissue in the human body. The work is being done using open-source software, enabling other researchers to more easily replicate it.
Stryker detailed its robotic surgery plans during its Q3 earnings calls as it prepares for the commencement of total knee replacements on the Mako robot. The launch of the new Mako application will commence later this year, ramping up slowly and reaching full speed toward the end of 2016.