The day before 60 Minutes aired Dick Cheney’s segment with Dr. Sanjay Gupta with a clip showing his Homeland-like concern over assassination by wireless medical device, Medtronic (MDT) released a statement reiterating its dedication to maintaining the security of its devices. The timing of such a statement–right after a promotion of a former vice president […]
St. Jude Medical (STJ) received an FDA safety alert for its Amplatzer ASO, a minimally-invasive implantable cardiac device used to treat atrial septal defect. The problem? In one to three of every 1,000 patients, ” tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery.” More on the […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
St. Jude Medical (STJ) announced it has acquired Nanostim, Inc., a California-based early-stage medical device company focused on leadless pacemaker technology, for $123.5 million. The startup could stand to gain up to an additional $65 million if it meets certain milestones. This deal culminates a partnership that began on May 3, 2011, when STJ decided […]
Neuros Medical, a Cleveland-based medical device company, received an FDA investigational device exemption approval to begin a clinical study on its technology for intractable limb pain management for amputees. According to the company website, the Altius System High Frequency Nerve Block technology “consists of an electrode (also known as a lead) placed around a peripheral […]
In a tight vote Tuesday, a U.S. Food and Drug Administration Circulatory Systems Device Advisory Panel recommended Medtronic‘s (MDT) CRT devices are beneficial for biventricular pacing when treating patients with atrioventricular block and left ventricular systolic dysfunction. The vote that the overall benefits outweigh potential risks–four recommend, three no and one abstain–was based on clinical […]
Biotronik, an Oregon-based cardiovascular medical device company, announced it received final FDA device approval for its Ilesto DX, an implantable cardiac defibrillator. Earlier this year, it received FDA device approval for family of implantable cardioverter-defibrillator and cardiac resynchronization therapy defibrillators. This week’s approval is an “upgraded” device. This “smaller, thinner” new generation platform allows for a […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
We can now grow complex human brain tissue in a test tube. Scientists in Vienna, Austria, used a method that allows pluripotent stem cells to develop into mini-brains (i.e., cerebral organoids) that even have several distinct brain regions, according to an article in this issue of Nature. While this year has seen 3-D printed miniature […]
Medtronic makes history in neurostimulation devices today, receiving FDA-approval for the first implantable spinal cord stimulation systems for use in the treatment of back pain for conditionally safe full-body MRI under specific conditions. Its RestoreSensor® SureScan® MRI neurostimulation systems will allow patients with the implant to undergo an MRI, previously impossible due to the magnetic fields […]
CVRx, a Minneapolis-based firm that has developed proprietary implantable technology for the treatment of high blood pressure and heart failure, has raised $29.6 million for advancing clinical trials of its Barostim Neo, as well as expanding commercial activities abroad. Johnson & Johnson Development Corp. and New Enterprise Associates, Inc. were the co-lead investors. According to […]