Masimo (Irvine, CA) received FDA clearance for Centroid, a wearable, wireless patient orientation, activity, and respiration rate sensor. According to the company, Centroid helps clinicians monitor patient position to avoid preventable pressure ulcers, and can alert clinicians to sudden movements such as fall-like events. The device also detects chest movements to continuously … [Read more...]
XPOVIO (selinexor), FDA approved for treatment of relapsed or refractory diffuse large B-cell Lymphoma (DLBCL), available at Biologics by McKesson
Biologics by McKesson, an independent specialty pharmacy specializing in oncology, rare diseases and other complex therapeutic areas, was selected by Karyopharm Therapeutics, Inc. as a specialty pharmacy provider for XPOVIO (selinexor) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (RR DLBCL), not otherwise specified, including … [Read more...]
Best-selling physician scale from Health o meter Professional Scales now available in an Origin USA version
The market's #1 physician scale is now available in a TAA compliant (Origin USA) version. The 501KL series of scales provides the physician or clinician with a safe and flexible option to weigh their patients with confidence. The 501KL has all the same features as the 500KL and more and has a USA origin. The new 501KL is available for purchase exclusively through Health o … [Read more...]
FDA approves Medtronic’s Percept PC Neurostimulator with BrainSense Technology
Medtronic plc (Dublin, Ireland) announced it received FDA approval for the Percept PC Deep Brain Stimulation (DBS) system. BrainSense technology makes Percept the first and only DBS neurostimulation system with the ability to chronically capture and record brain signals while delivering therapy to patients with neurologic disorders associated with Parkinson’s disease, essential … [Read more...]
Cook Medical to distribute Advance Serenity Hydrophilic PTA Balloon Catheter in U.S.
Cook Medical (Bloomington, IN) announced that the Advance Serenity Hydrophilic PTA Balloon Catheter, manufactured by Surmodics, is now available to physicians in the United States. Advance Serenity is a hydrophilic-coated angioplasty balloon catheter designed to meet the technical needs of clinicians for treatment of patients who suffer from peripheral artery disease (PAD) … [Read more...]
Medtronic’s ABRE study meets primary safety, effectiveness endpoints
Medtronic plc (Dublin, Ireland) announced results from the ABRE clinical study assessing the safety and effectiveness of the investigational Abre venous self-expanding stent system in subjects with iliofemoral venous outflow obstruction. Medtronic said that the study met the primary safety and effectiveness endpoints. The ABRE Study is a prospective, interventional, … [Read more...]
Hillrom launches new connected remote vital signs monitoring Extended Care Solution
Hillrom (Chicago, IL) launched the Hillrom Extended Care Solution, a new, connected remote vital signs monitoring device that “allows clinicians to shift care closer to home.” Hillrom's Extended Care Solution combines an the recently launched Welch Allyn Spot Vital Signs 4400 device –– an all-in-one vital signs solution –– with a patient app and clinician review portal to … [Read more...]
Sysmex launches Flow Cytometer XF-1600 in North America
Sysmex Corporation (Kobe, Japan) announced the launch of its XF-1600 flow cytometer for laboratories in the North America market in June 2020. Capable of performing analyses on numerous applications, the XF-1600 comes with “flexibility with which to respond to diverse researcher needs,” the company said. Together with Sysmex’s the PS-10 sample preparation system launched in … [Read more...]
Abbott’s FreeStyle Libre 2 ICGM cleared in U.S. for adults, children with diabetes
Abbott (Abbott Park, IL) announced that the U.S. Food and Drug Administration (FDA) cleared its next-generation FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system for adults and children ages 4 and older with diabetes. According to the company, this is the only iCGM system with optional real-time alarms that measures glucose levels every minute, … [Read more...]
Sekisui Diagnostics announces FDA clearance, CLIA Waiver of OSOM Ultra Plus Flu A&B Test
Sekisui Diagnostics announced it received FDA clearance and CLIA Waiver of the OSOM Ultra Plus Flu A&B Test intended for the qualitative detection of influenza type A and type B nucleoprotein antigens directly from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. According tot he company, the test utilizes … [Read more...]