A number of digital health devices have recieved FDA 510(k) clearance in the last month, including a number of apps and devices in the cardiac health space. Some clearances are updates to companies that have one or more existing clearances, while some are newly cleared devices. Read on for a roundup of connected ECG sensors, medical device companion apps, and wearable patches.
1. St. Jude Medical...
The remote patient monitoring market saw a big jump in the last year, with 7.1 million patients in 2016 enrolled in some form of digital health program featuring connected medical devices as a core part of their care plan, according to new data.
Swedish market research firm Berg Insight, which specializes in IoT verticals, tracked a 44 percent jump in remotely monitored patients last year. While...
Pasadena, California-based Geneva Health Solutions, which makes a remote monitoring platform for cardiology practitioners, has raised $1.9 million in Series A funding in a round led by Nebraska Medicine, an early adopter of the cloud-based platform that aggregates data from a patient’s implanted cardiac device to their provider.
The funding will be used to carry the company through the next year...
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...
The U.S. market for "advanced" wireless patient monitoring systems more than doubled in a four-year period, from $3.9 billion in 2007 to $8.9 billion in 2011 – at an annual rate of nearly 23 percent – according to a new report from Kalorama Information, and the growth should continue at nearly the same pace. The New York-based research firm forecasts that total to expand by 18 percent annually,...
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....
St. Jude Medical announced new features for its Merlin.net remote patient monitoring offering, Patient Care Network (PCN), including mobile alerts for physicians and improved data export to EHRs.
Mobile DirectAlerts, a notification system for iOS, Android, and BlackBerry devices, enables physicians to receive messages whenever a patient triggers the device's alert system.
In addition, an Auto...
The USC Center for Body Computing (CBC), an initiative to study and create the future of wireless medicine, recently announced its 17 founding members. The members will support wireless health research and innovation, and help develop product prototypes.
The founding members of the CBC include Agamatrix, AirStrip Technologies, Apollo Health Resources, Avery Dennison Medical Solutions, Ayogo Games...
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...
St. Jude Medical and iRhythm Technologies have inked a deal to co-market iRhythm's Zio Patch, an wearable, single-use continuous ambulatory cardiac rhythm monitor. The Zio patch recently received 510(k) clearance from the FDA and is prepping for a commercial launch in the US, which is where the company's new cash infusion comes in:
iRhythm also announced a $10 million round of financing that was...
