Scalpel Weekly News

Week of: July 02, 2018

IN THE NEWS


First Continuous Glucose Monitor with Implantable Glucose Sensor

On June 21, 2018, the FDA granted Senseonics, Inc., approval to market the Eversense Continuous Glucose Monitoring (CGM) system for use in diabetics 18 years of age and older. This is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days. Click title to continue reading...


 
MEDICAL ALERTS


First Catheter-Based Systems for Vascular Access; Hemodialysis

On June 22, 2018, the FDA granted approval for the marketing of two catheter-based devices designed to create an arteriovenous (AV) fistula for patients who need hemodialysis access. Approval was granted to Avenu Medical to market the Ellipsys Vascular Access System and TVA Medical, Inc. to market the everlinQ endoAVF System. According to the National Institutes of Health, more than 661,000 Americans have kidney failure, of which approximately two-thirds are on hemodialysis. Hemodialysis utilizes a dialyzer, or artificial kidney, to filter a patient’s blood outside of the patient’s body. Click title to continue reading...



Automated Insulin Delivery System Approved for Pediatric Use

On June 21, 2018, the FDA granted Medtronic expanded approval to market the MiniMed 670G hybrid closed looped system, a diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the user, to individuals aged seven to 13 with type 1 diabetes. The FDA originally approved this device in September 2017 for use in patients 14 years of age and older with type 1 diabetes. Click title to continue reading...



2.5 Million High School Students Sustained Concussions in 2017

On June 22, 2018, the CDC published a report that found that, in 2017, an estimated 2.5 million high school students reported having at least one concussion related to sports or physical activity during the preceding year. An estimated one million students reported having two or more concussions during the same time frame. Playing on more than one sports team was found to further increase the risk for concussion. Click title to continue reading...


  CASE ALERTS


$13M Verdict: Transvaginal Mesh Design Defect, Failure to Warn

A woman suffered from pelvic organ prolapse (POP), which occurs when pelvic floor muscles become weak or dysfunctional and cease supporting the organs in the pelvic area, causing connective tissue attachments to stretch or break, allowing the bladder, uterus, vagina, small bowel, and/or rectum to drop into the vaginal canal. Click title to continue reading...



No Ex Parte Contact with Plaintiff’s Physicians Without Agreement or Court Order

A woman suffered a fractured clavicle. An orthopedic surgeon performed corrective surgery. The woman experienced continued pain and discomfort following the surgical procedure. A different orthopedic surgeon in the same practice group evaluated the woman. The woman ended treatment at the practice group and sought care elsewhere. Click title to continue reading...



Clinic’s Contract Claims Proceed Against Medical Billing Provider

A company provided billing services to healthcare providers through proprietary billing and medical records management software. The company’s billing software functioned as a platform for healthcare providers to submit claims to the company for transmission to insurers. The company’s medical records management software worked in conjunction with its billing software. Click title to continue reading...


FEATURE


Checklist: Initial Client Interview-Recovery Room Injury

As a special feature for our Premium subscribers we have included this feature containing a checklist of basic information counsel should gather in order to consider the likely success of a negligence action regarding a patient’s injury resulting from the patient’s post-surgical recovery room care. The checklist can be used as a guide for counsel for the initial client interview. Counsel may obtain the documents noted at the interview through discovery document requests of the defendants: the surgeon, nurse, and outpatient health facility. Click title to continue reading...