Arterys announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Arterys Software. This clearance allows the Arterys product to be used in clinical settings for the quantification of cardiac flow, which includes 4D flow and 2D Phase Contrast workflows, and cardiac function measurements. The product seamlessly integrates into clinical practice to provide comprehensive, simple and quick Cardiac MR imaging. Previously, the Arterys Software received FDA clearance for its 4D Flow visualization feature.
Episurf Medical announced the public release of the Episealer surgical training simulation on the Touch Surgery app. The procedural simulation is now available to Touch Surgery’s audience of over 1.3 million users globally, which is a perfect match to the Episealer platform, a proprietary patient-specific approach to addressing knee lesions and previously untreatable joint pain problems.
Dexcom Inc. is recalling the Continuous Glucose Monitoring Systems because the audible alarm may not activate in the receiver piece when low or high glucose levels (hypoglycemia or hyperglycemia) are detected.
Relying on this product for notification of low or high blood sugar could result in serious adverse consequences, including death as the auditory alarm may not sound and users might not be notified of low or high blood sugar.
Dexcom, Inc. issued a press release on 11 April, 2016 to supplement its previous customer notification and remind its patients to periodically test the audible alarms and alerts on certain receivers manufactured by Dexcom to make sure that the audible alarms and alerts are functioning properly. The notification constituted a voluntary recall and applied to those Dexcom G4 Platinum Receivers, Dexcom G4 Platinum Pediatric Receivers, Dexcom G4 Platinum Professional Receivers, Dexcom G4 Platinum with Share Receivers, Dexcom G4 Platinum with Share Pediatric Receivers and the Dexcom G5 Mobile Receivers that are experiencing problems with audible alarms and alerts. There is no reason for patients to return receivers to Dexcom that are functioning properly.
Dexcom issued the customer notification on February 23, 2016 via its website and certified mail to patients. The notification alerted customers of a potential issue affecting the audible alarms and alerts associated with the speaker component of certain receivers. Dexcom notified customers about this potential issue after receiving customer complaints about the receivers’ speaker component. Specifically, the speaker failed to properly provide audible alerts and alarms in some or all instances.
Customers who rely on audible alerts and alarms may not be notified of severe hypoglycemia or hyperglycemia if the speaker in their receiver does not function properly. The immediate health consequences of severe hypoglycemia include loss of consciousness, seizure, and in rare instances death.
The FDA has identified this as a Class I recall, the most serious type of recall. Relying on this device may cause serious injuries or death.
Name of device: Dexcom G4 PLATINUM Receiver, Dexcom G4 PLATINUM (Pediatric) Receive, Dexcom G4 PLATINUM (Professional) Receiver, Dexcom G4 PLATINUM Receiver with Share, Dexcom G4 PLATINUM (Pediatric) Receiver with Share, Dexcom G5 Mobile Receiver
Model numbers: all models
Lot numbers: all lots
Manufacturing dates: July 29, 2011 to March 10, 2016
Distribution dates: October 22, 2012 to March 10, 2016
Devices recalled in the U.S.: 263,520 units nationwide
More information can be found from FDA website by clicking below links:
Hunan Province, China, will build its first ‘could hospital’ in Changsha City, capital city of Hunan Province.
The new hospital will integrate services for chronical diseases patients including gene test, blood pressure real time online monitoring, tele-medicine. The target of this new ‘cloud hospital’ is to serve around 3 million patients with chronical diseases yearly.
The so called ‘Cloud Hospital’consists of Zhongshan Hospital Affiliated to Fudan University, Central Hospital of Xuhui District and 13 society clinics. Patients with chronical diseases can download an APP, through which patient file can be synchronized between society clinics and Zhongshan Hospital, or patients can consult doctors online by video chat, make appointments with doctors, and society clinics can also transfer patients to hospitals by using the same APP.
This ‘Cloud Hospital’had treated 160.000 patient/time since its kick off in August 2016.
In the first 3 quarters of 2015, the Chinese m-Health cluster secured ca. $1.1 billion investment, though almost no new products or services were launched other than peripheral products like smart phone APPs, online patient-doctor appointment system, online consulting platform. Wearable device was one of the most discussed topics in 2015.