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 […]
Patient Monitoring
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 […]
ArcherDX wins breakthrough nod for personalized cancer monitoring tech
ArcherDX announced that it has won breakthrough device designation from the FDA for its personalized cancer monitoring (PCM) technology. Boulder, Colo.-based ArcherDX’s PCM platform is designed for minimally invasive monitoring and recurrence surveillance for early-stage cancer treatment. It is meant to offer healthcare providers access to genomic information in their laboratory. ArcherDX also recently won […]
Masimo to acquire NantHealth’s connected care business
Masimo (NSDQ:MASI) will pay $47.25 million upfront to acquire the connected care business of Culver City, Calif.–based NantHealth (NSDQ: NH), the company said today. NantHealth’s connected care business provides medical device interoperability to hospitals and health systems, with products including DCX device connectivity (formerly known as DeviceConX), VCX patient vitals software (formerly known as VitalsConX), the […]
Masimo claims Apple infringed 10 of its health-monitoring patents
Patient-monitoring company Masimo (NSDQ:MASI) and spinoff company Cercacor filed suit yesterday accusing Apple (NSDQ:AAPL) of poaching its employees and infringing 10 of its patents to improve the health monitoring functions of the Apple Watch. The lawsuit, filed in federal court in California, claims that in 2013, Apple contacted Masimo and asked to meet regarding a […]
CES 2020: Medical technologies you need to know
The mobile health devices and wearables trend is seemingly accelerating this year, with 546 digital health and 635 wearable devices being touted at the annual CES show in Las Vegas. Digital health devices and wearables on display are up from the 505 and 620 devices, respectively, presented at CES 2019. Health and medical devices being […]
Senior-monitoring company Somatix raises $4.5m
Somatix (New York) — a four-year-old company with a monitoring system that spots problems in seniors via their gestures — has raised $4.5 million. The SEC Form D, files yesterday, listed nine investors in the offering. The company’s SafeBeing remote monitoring system passively tracks walking, sleeping, drinking, medication intake and more. The monitoring enables the […]
Doctor sues Apple over AF detector
A New York cardiologist claims Apple (NSDQ:AAPL) is infringing his patent for a device to detect atrial fibrillation. Dr. Joseph Wiesel, a clinical assistant professor of cardiology at New York University School of Medicine, was granted the 7,020,514 patent in 2006 for a “method and apparatus to determine possible atrial fibrillation.” The apparatus comprises a […]