Showing all posts written by Aaron Johnson

Aaron Johnson
Aaron Johnson
Aaron S. Johnson is an associate in the firm's Orange County office. His practice includes patent prosecution, IP litigation, and due diligence.

Aaron received his Bachelor of Science in Civil Engineering from the University of California, Irvine. Aaron later received his Master of Science degree in Civil Engineering from the University of California, Berkeley, specifically within the Structural Engineering, Mechanics, and Materials Department (SEMM). Aaron's master's thesis involved research and analysis of seismic base isolation systems. While at UC Berkeley, Aaron worked as a graduate student instructor for first-year students majoring in mechanical and civil engineering. After graduating, Aaron worked as a structural engineer and earned his professional engineer license.

Aaron earned his law degree from the University of California, Irvine, where he served as a teaching assistant for a first-year Lawyering Skills course and as a research Editor on the UC Irvine Law Review. Aaron also worked at the UCI Intellectual Property, Arts, and Technology Clinic.

Mr. Johnson worked as a summer associate in 2016 before joining the firm as an associate in 2017.
Apple’s Latest Watch Receives FDA Approval For ECG Functionality

Apple’s Latest Watch Receives FDA Approval For ECG Functionality

Since its first release in 2015, the Apple Watch has continued to evolve and incorporate more health- and fitness-tracking capabilities. The latest version of Apple’s Watch—Series 4—features a larger display screen, thinner case, a new interface, and, according to Apple “revolutionary health capabilities.” These health capabilities include electrocardiogram (ECG) functionality, which has been granted approval by the U.S. Food and Drug Administration. Also incorporated into the latest version of the Watch, according to Apple, are a new accelerometer and gyroscope that allow for fall detection.

Jeff Williams, Apple’s chief operating officer, stated:

The completely redesigned Apple Watch Series 4 continues to be an indispensable communication and fitness companion, and now with the addition of groundbreaking features, like fall detection and the first-ever ECG app offered directly to consumers, it also becomes an intelligent guardian for your health.

Apple notes that its Series 4 Watch allows wearers to place their finger on a dial for 30 seconds and receive a heart rhythm classification, which can identify if the wearers’ heartbeat is following a normal or irregular pattern. Irregular heart beat patterns, often referred to as Atrial fibrillation, increase the risk of heart complications. Recordings of such heart rhythm information are stored in a Health app and can be shared with physicians via a PDF file.

Some commentators believe the fall detection capabilities of Apple’s Series 4 Watch may prove significantly valuable, especially for elderly wearers. The Series 4 Watch is said to incorporate a new accelerometer and gyroscope which measure up to 32 g-forces and utilizes “custom algorithms to identify when hard falls occur.” The Watch also analyzes trajectory of the wearer’s wrist and the impact of accelerations, and sends an alert to the wearer after a fall event. Such alert can be dismissed or used by the wearer to make an emergency call to a healthcare provider. According to Apple, if the Watch senses a lack of movement for one minute after the alert notification, an automatic emergency call is made and a message is sent to emergency contacts along with location data.

 

Senseonics Gets Green Light from FDA on Implantable Glucose Monitoring System

Senseonics recently received Premarket Approval from the Food and Drug Administration (FDA) for its Eversense® Continuous Glucose Monitoring (CGM) System. According to Senseonics, the Eversense® CGM System is the first and only implantable device to allow for continuous blood-glucose monitoring for as long as three months.

The Eversense ® CGM system includes an implantable glucose sensor, a wearable transmitter, and the Eversense Mobile App. Senseonics advertises the sensor as utilizing fluorescent, glucose indicating polymer technology to measure glucose in the interstitial fluid. According to Senseonics, measurements from the sensor are conveyed to the wearable transmitter, which wirelessly communicates with the Eversense Mobile App to display real-time glucose measurements, trends, and alerts. 

Commenting on the FDA approval, Senseonics President and CEO Tim Goodnow stated:

 “With the parallel trends of wearable personal devices and medical implantables for people to manage their health, this product exemplifies the natural evolution for diabetes devices, and Senseonics is excited to help lead the way.”

Xeris’ Pharmaceuticals Glucagon Progresses Towards FDA Approval

Xeris Pharmaceuticals, Inc. (“Xeris”) recently announced successful completion of both adult and pediatric clinical studies for its glucagon rescue pen. According to Xeris’ President and CEO Paul Edick:

Xeris is on-track to submit an NDA for our ready-to-use glucagon rescue pen for the treatment of severe hypoglycemia in late Q2 of this year.  We will use the data from the Phase 3b study to gain additional information regarding the entire treatment episode, including preparation and administration time of the current glucagon emergency kits versus our rescue pen auto-injector, for people with diabetes who may require glucagon in emergency situations.

Xeris also recently released results from a Human Factors usability and reliability study which, according to Xeris, demonstrated a 99% success rate for patients in administering full doses of glucagon with the rescue pen using a simple 2-step process.

Xeris notes that glucagon treatment is critical for persons susceptible to severe hypoglycemic events. Severe hypoglycemia, if untreated, can result in seizures, coma, brain damage, and if left unaddressed, even death. Along with insulin, glucagon helps maintain the glycemic control system which in turn keeps blood glucose at optimum levels within the body. The American Diabetes Association recommends glucagon be prescribed for persons facing increased risks of hypoglycemia. According to Xeris, due to limitations in current glucagon products and the difficulty involved in administration methods (especially in emergency situations), such treatments have been underutilized by persons at risk of suffering from severe hypoglycemic events.

According to Xeris, their rescue pen aims to provide ready-to-use, room-temperature stable, and injectable and infusible drug formulations. Xeris’ proprietary XeriSolTM and XeriJectTM formulations are currently being examined for administration in both subcutaneous and intramuscular delivery sites. Xeris states that unlike some injectable drug formulations provided as a powder that is later reconstituted with water at the time of administration, Xeris’ formulations are non-aqueous, ultra-concentrated and ultra-low volume, biocompatible solutions or pastes. Xeris also reports that their formulations are packaged in a ready-to-use compatible syringe, such as its rescue pen auto-injector, or other compatible devices, such as vials, pens, or pumps.