The FDA said it cleared the first fully disposable duodenoscope, made by Boston Scientific. The EXALT Model D Single-Use Duodenoscope is designed for use in endoscopic retrograde cholangiopancreatography procedures. It is the first single-use duodenoscope on the market and was granted Breakthrough Device Designation. “The availability of a fully disposable duodenoscope represents another major step […]
Siemens Healthineers lands FDA clearance for two CT systems
Siemens Healthineers this week said it won FDA clearance for its Somatom go.Sim and Somtom go.Open Pro computed tomography systems. The CT systems are designed for radiation therapy planning and are members of the company’s Somatom go. platform of devices. Get the full story on our sister site, Medical Design & Outsourcing.
In2Bones launches AlloAid BioNail
In2Bones this week launched its AlloAid BioNail sterile allograft implant. The implant is designed to give rigid, stable fixation during hand and foot reconstruction. AlloAid BioNail is made from strong cortical allografts to provide osteoconductive properties for bone remodeling and healing. It features a tapered point and multiple, contoured wedge facets to ease insertion, anchor […]
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, […]
Haemonetics opens new Boston headquarters
Haemonetics (NYSE:HAE) said this week it opened its new global headquarters in Boston. The new location will help the company bring together its corporate and commercial teams with its research and development organization. “Relocating our headquarters to Boston is an important step in Haemonetics’ transformation,” president and CEO Chris Simon said. “Our new downtown location in […]
Employees say Intuitive Surgical, J&J, Stryker best places to work in 2020
Intuitive Surgical (NSDQ:ISRG), Johnson & Johnson (NYSE:JNJ) and Stryker (NYSE:SYK) were recently named as Glassdoor’s employees’s choice of Best Places to Work in 2020. Each year, Glassdoor uses feedback that employees have shared on the website over the past year to compile a list of the best places to work in 2020. Employee reviews provide Glassdoor with insights […]
Eitan Group signs service agreement with Integrated Medical Systems
The Eitan Group this week said it signed a service partnership with integrated Medical Systems. Through the agreement, Integrated medical Systems will be the service provider for the Eitan Group’s Sapphire infusion pumps that are used in hospital-based and alternate site infusion. Get the full story on our sister site, Drug Delivery Business.
Biolase lands 510(k) for dental hygiene laser
Biolase (NSDQ:BIOL) this week announced it has received FDA 510(k) clearance for its Epic Hygiene dental laser. The laser system allows dental hygienists to manage non-surgical periodontitis and increase clinical production. It offers a step-by-step clinical protocol with pocket therapy and perio debridement for easy implementation. “We were thrilled to announce the launch of the Epic […]
ViewRay issues urgent field safety notice for MRIdian System Treatment Planning and Delivery System
ViewRay (NSDQ:VRAY) has issued a field safety notice for its MRIdian System Treatment Planning and Delivery System software. The urgent device correction stems from some cases where a dose that was previously administered to a patient may not be accurately registered with the daily scan. There have been no reports of patients affected by the issue. […]
McKesson names new chief information and technology officer
McKesson this week announced it appointed Nancy Flores as executive VP, chief information officer and chief technology officer, effective Jan. 13, 2020. Flores will be responsible for the enterprise business technology strategy, technology governance across the corporation, IT security and risk management, infrastructure operations and service delivery. She will replace Kathy McElligott who announced she […]