Nihon Kohden (TYO:6849) announced the U.S. launch of its Life Scope SVM-7200 series vital signs monitor for outpatient facilities and beds that aren’t continuously monitored. The Life Scope SVM-7200 is designed to provide customizable early warning scoring to help clinicians identify patients who are deteriorating or at risk of deterioration. It combines vital signs data with […]
Iradimed renews CE mark for MRI-safe patient monitor
Iradimed (NSDQ:IRMD) today said it completed the CE mark renewal process and resumed shipments of its patient vital signs monitoring systems. “We are very pleased with obtaining the CE mark renewal certificate for our patient monitors. With the renewed certificate, we are immediately resuming shipments to the impacted customers and thank them for their patience,” president […]
ImpediMed lands expanded 510(k) clearance for Sozo
ImpediMed this week said it received expanded FDA 510(k) clearance for its Sozo bioimpedance spectroscopy device. The expanded clearance allows the Carlsbad, Calif.-based company to market the Sozo device for assessing patients that are at risk of Protein Calorie Malnutrition (PCM) and for tracking clinically relevant body composition parameters in all patients. “Many chronic diseases, […]
Masimo touts study on remote monitoring for desaturation and bradypnea
Masimo (NSDQ:MASI) announced today that its study of the Masimo Patient SafetyNet and rainbow acoustic monitoring (RAM) with RRa revealed that use of monitoring systems might provide a safety net for postoperative patients. Irvine, Calif.-based Masimo’s Patient SafetyNet is a supplemental remote monitoring patient surveillance and clinician notification system designed to work with Masimo and third-party […]
GE Healthcare safety notice: Telemetry alarms may not sound
GE Healthcare (NYSE:GE) released an urgent field safety notice to warn of six potential safety issues with its ApexPro telemetry system under certain conditions. The ApexPro is supposed to provide vital patient information in healthcare settings. But when the ApexPro telemetry transmitter is out of wireless range, its battery has been depleted or a communication failure […]
FDA panel wants info on metal implant reactions
This article has been updated with a link to the FDA webcasts of the proceedings. An FDA panel will meet this week to discuss immunological responses to medical device implants made of metal, including artificial hips and the Essure permanent birth control device. The Immunology Devices Panel of the agency’s Center for Devices and Radiological […]
Philips launches next-gen vital signs monitor for early patient intervention
Royal Philips (NYSE:PHG) said today that it has initiated the U.S. launch of the EarlyVue VS30 monitor — meant to help clinicians catch problems with hospital patients early and prioritize treatments. The EarlyVue VS30 uses automated early warning scoring (EWS) to collect the vital signs and calculate the alerts to allow clinicians to identify subtle signs […]
Sleep Data, BetterNight raise $6m
Sleep Data said it raised $6 million to back the market expansion of its BetterNight virtual care platform. BetterNight, which launched in 2018, is designed to access care through telemedicine and remote patient monitoring to deliver lower cost of care and improved outcomes. San Diego-based BetterNight will put the funding toward market expansion of the […]
LifeScan inks deal to broker institutional sales for OneTouch Reveal Plus
LifeScan said yesterday that it entered into an agreement with Willis Towers Watson to expand the commercialization of its OneTouch Reveal Plus digital diabetes therapy system. The companies hope the collaboration will see LifeScan and Willis Towers Watson combine to support self-insured employers in helping their employees and dependents manage diabetes. The OneTouch Reveal Plus […]
Endotronix expands Series D to $70m
Endotronix said today that it added $35 million to the Series D round it first closed a year ago for the Cordella cardiovascular monitoring technology it’s developing. The Lisle, Ill.-based company initially closed the Series D at $45 million on Sept. 14, 2018, earmarking the proceeds for CE Mark approval in the European Union and […]
U.S. exempts more Chinese medtech products from tariffs
The U.S. has exempted another 18 medical devices or device components from the 25% tariffs imposed on Chinese goods by the Trump administration. The new list includes ultrasound, X-ray, MRI and infusion equipment. The Office of the U.S. Trade Representative (USTR) said the new exclusions are retroactive to August 23, 2018, when additional tariffs went […]
- 1
- 2
- 3
- …
- 56
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
YouTube