CloudCath announced today that it completed a $12 million Series A financing round for its at-home dialysis monitoring treatment platform. San Francisco–based CloudCath’s system, which is its first product, is designed to enable remote, real-time monitoring for people undergoing at-home peritoneal dialysis to allow for earlier complication intervention. Proceeds from the funding round are also […]
Patient Monitoring
Baxter, Cosmed win FDA clearance for portable metabolism monitor
Baxter (NYSE:BAX) announced that it won FDA 510(k) clearance for the Q-NRG+ metabolic monitoring device developed by its partner Cosmed for helping with nutrition therapy. Q-NRG+ uses indirect calorimetry (IC) technology to measure a patient’s calorie needs or resting energy expenditure (REE). Together, those readings can be used to inform prescription and administration of nutrition therapy, […]
BioIntelliSense wins FDA nod for BioSticker continuous vital sign monitor
BioIntelliSense announced that it won FDA 510(k) clearance for its BioSticker on-body sensor for scalable remote care and initiated the U.S. commercial launch of the product last week. The BioSticker is designed to allow for continuous monitoring of vital signs and actionable insights to provide opportunities for early detection of potentially avoidable complications from a […]
GE Healthcare recalls nearly 3,600 anesthesia systems
GE Healthcare (NYSE:GE) is recalling certain Carestation anesthesia systems in the U.S. due to a problem that could halt patient ventilation, according to the FDA. FDA labeled the recall as Class I, the most serious type of medical device recall. The Carestation 620/650/650c A1 models may have a loose interior cable connection that could cause […]
GE Healthcare respiratory analyzer recall is Class I
The FDA has designated a recall of certain GE Healthcare (NYSE:GE) respiratory analyzers used in patient monitoring as Class I, the most serious type of recall. GE Healthcare began the recall of Carescape respiratory modules and Airway Gas Option NCAiO units in September 2019 because faulty oxygen sensors may cause them to display incorrect patient oxygen […]
Homeland Security updates cybersecurity warnings involving some Medtronic products
The U.S. Department of Homeland Security (DHS) has updated cybersecurity warnings on multiple Medtronic (NYSE:MDT) programmer products due to a variety of errors occurring with the devices. The devices that DHS warned about include the Medtronic 2090 CareLink programmer, 29901 Encore programmer, MyCareLink monitor and the CareLink monitor. All warnings are updates on previous advisories from […]
Medtronic gains CE Mark for next-gen ICDs
Medtronic (NYSE:MDT) announced today that it has received the CE Mark for its Cobalt and Crome portfolio of implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy-defibrillators (CRT-D). ICDs monitor heart rhythms and deliver therapy to correct heart rates that are too fast and can lead to sudden cardiac arrest. CRT-Ds, a treatment option for some individuals […]
Dräger Medical cited in FDA warning letter
This article has been updated with comments from Dräger Medical. The FDA has issued a warning letter to Dräger Medical following an inspection of its Andover, Mass., facility in August and September 2019. The agency faulted the patient-monitoring company for failing to file for 510(k) clearance of its Infinity acute care system (IACS) M540 although it made […]
Certain GE Healthcare patient-monitoring devices vulnerable to cyberattack
The federal government and GE Healthcare (NYSE:GE) announced today that the certain of the company’s patient monitoring devices are vulnerable to cyberattack. If attacked, some versions of the Carescape and ApexPro telemetry servers, the Carescape Central Station version 1 and Central Information Center systems could stop monitoring patients, silence alarms or produce unnecessary alarms during […]
Mindray issues urgent field safety notice for Genius 2 tympanic thermometers
Mindray Medical issued an urgent field safety notice in Europe to warn of a calibration-related accuracy issue with Cardinal Health’s (NYSE:CAH) Genius 2 tympanic thermometers that are integrated into four versions of the Mindray VS-900 patient monitors. The affected Genius 2 thermometers were manufactured after Oct. 1, 2016, and may have been distributed with the Mindray […]
FDA clears Verily Study Watch for additional capabilities
Verily, Google’s life science’s sister company under Alphabet (NSDQ:GOOGL), has received an FDA 510(k) clearance to include an irregular pulse monitor in its Study Watch wearable. The FDA announcement, last updated Jan. 20, did not include additional information. The agency cleared ECG capabilities on the Study Watch in January 2019. Launched in April 2017, the Study […]