July 16, 2015
St. Jude Medical has announced that it received FDA 510(k) clearance for the St. Jude Medical Invisible Trial System, which is a mobile-enabled discreet spinal cord stimulation (SCS) trial system.
Patients who need spinal cord stimulation therapy, which helps them manage chronic pain, can have small device implanted in their body. The implant connects to thin wires, called leads, which deliver...
May 29, 2014
Atlanta, Georgia-based health device maker CardioMEMS received FDA clearance for its CardioMEMS HF System, which monitors pulmonary artery pressure, but for patients who have experienced New York Heart Association (NYHA) Class III heart failure and have been hospitalized for heart failure in the previous year.
After the small sensor is implanted into the pulmonary artery, which is a blood vessel...
July 2, 2012
The fact that more than 30 percent of American households no longer have landlines might have some unintended consequences in healthcare.
As the Wall Street Journal reports, implanted defibrillators may be wireless devices, but the in-home base stations the heart monitors transmit data to still need landlines to relay information to the device makers. The manufacturers, notably Medtronic and St....
December 13, 2011
CardioMEMS ran into a regulatory roadblock last week, when an FDA advisory panel recommended that the agency not approve the company's Champion HF Monitoring System. The device is said to be the first permanently implantable, wireless device for remote monitoring of patients with heart failure.
Though the FDA's Circulatory Systems Devices Panel voted 9-1 that the implantable monitor was safe, the...
September 8, 2010
Will heart failure sensor startup CardioMEMS be wireless health's first big acquisition target? Medical device maker St. Jude Medical just announced a $60 million equity investment in CardioMEMS, which includes the exclusive option to acquire the startup for $375 million after certain milestones are met. The current investment also grants St. Jude a 19 percent stake in CardioMEMS.
Cash flush with...
August 4, 2010
During a panel session I moderated last week, Parks Associates Director of Mobile & Health Research Harry Wang shared a number of metrics and industry trends with attendees at the second annual World Congress Mobile Health Summit in Boston, Massachusetts.
Wang began by breaking down the wireless health industry into three specific categories based on the type of wireless technology used: Body...
June 2, 2010
CardioMEMS, the company developing a wireless implantable sensor for heart failure patients, has recently announced the results of its nearly three year-long CHAMPION trial. One of the topline results from the trial: The number of hospitalizations for heart failure patients reduced by 38 percent over the the full duration of the study.
CHAMPION stands for: CardioMEMS Heart Sensor Allows...
May 10, 2010
CardioMEMS, which develops wireless, implantable medical sensors, announced a new $37.9 million round of venture capital investment. That brings the company's total raised capital amount to about $145 million. Previous investors include Arcapita Ventures, Boston Millennia Partners, Medtronic, Easton Capital Partners, Foundation Medical Partners, Arboretum Ventures, Deerfield Capital Management,...
December 29, 2009
According to MobiHealthNews' year-end report, there were 15 venture capital investments announced during 2009 and 11 of them were for wireless remote patient monitoring start-ups. The remainder included a start-up working on a converged platform for physicians-patient communications, a smartphone app developer focused on fitness games, a call-in physician consultation service, and a tablet-based...
September 4, 2009
According to a report by MedMarket Diligence, investments and other financings into the medical technology market have topped $400 million during both July and August. September is expected to bring another month with more than $400 million in investments.
Wireless sensing and communications developer CardioMEMS was one medtech company that scooped up funding last month: the company announced a $...