Biotronik wins FDA nod for Acticor, Rivacor high-voltage tachycardia devices
Biotronik said yesterday it won FDA approval for its Acticor and Rivacor high-voltage cardiac rhythm management devices intended for treating patients with cardiac arrhythmias.
The clearance covers the Berlin, Germany based company’s Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX devices.
“When determining the best treatment plan for each patient, we assess individual needs and select a device system that provides optimal therapy programming with critical diagnostic features. We are often forced to choose between important features, which could compromise opti...
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Featured Food & Drug Administration (FDA) Regulatory/Compliance Biotronik Source Type: news
Oberd launches AI-assisted tech for gathering outcome data
Patient-reported outcomes vendor Oberd said it has launched software designed to reduce a patient’s time in completing outcomes surveys for orthopedic procedures.
Patient-reported outcomes can help quantify the value of a healthcare provider’s services. Columbia, Mo.-based Oberd’s computer-adaptive test (CAT) software has been developed and validated for all of the outcomes surveys approved by the American Academy of Orthopaedic Surgeons (AAOS). The technology, which uses artificial intelligence (AI), has been used in both test and live settings by the Geisinger Health System and will be featured in an article in t...
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News News Well Orthopedics Software / IT American Academy of Orthopaedic Surgeons (AAOS) oberd Source Type: news
Fresenius wins FDA breakthrough device nod for fluid management software
Fresenius (NYSE:FMS) said yesterday that it won FDA breakthrough device designation for its computer-assisted ultrafiltration control software intended to improve fluid management during hemodialysis.
The Waltham, Mass.-based company said that the software is designed to work with its newer hemodialysis machines using its CLiC device.
Fresenius said that with the software, it hopes to create a dialysis machine with embedded intelligent diagnostics to provide computer-assisted recommendations for achieving target levels of relative blood volume.
“This new software represents our commitment to driving innovation and a...
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Dialysis Featured Food & Drug Administration (FDA) Software / IT Fresenius Source Type: news
Xeris launches Ph2 trial of ready-to-use liquid glucagon
Xeris Pharmaceuticals (NSDQ:XERS) said today that it dosed the first patients in a Phase II trial of its ready-to-use liquid glucagon in people with Type 1 diabetes.
The Chicago-based company expects to report top-line data from the study in the second half of 2019.
Get the full story at our sister site, Drug Delivery Business News.
The post Xeris launches Ph2 trial of ready-to-use liquid glucagon appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Diabetes Drug-Device Combinations Featured Pharmaceuticals Wall Street Beat xerispharmaceuticals Source Type: news
10 orthopedic products from AAOS 2019 you need to know
Attendees line up to register for the American Academy of Orthopaedic Surgeons annual meeting in Las Vegas this week. More than 30,000 people were expected. (Image from AAOS)
The American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Las Vegas is abuzz about robotics, according to industry analysts from SVB Leerink.
While the SVB Leerink analysts termed Stryker’s (NYSE:SYK) Mako platform “best-in-class,” it’s an expanding category. Other major orthopedics companies are using this week’s AAOS meeting to introduce new offerings or tout updates to existing ones.
Johnson & Johnson (NYSE:JNJ), for ...
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Featured Implants News Well Orthopedics Surgical American Academy of Orthopedic Surgeons (AAOS) conformis DJO Global Kyocera Orthosensor Inc. Smith & Nephew Stryker Zimmer Biomet Source Type: news
