AID

Sequel’s twiist™ Automated Insulin Delivery System Receives FDA 510(k) Clearance

Retrieved on: 
Monday, March 18, 2024
CGM, Organization, Cell, DEKA, Entrepreneurship, AID, Insulin, Diabetes, Patient, Life, Pancreas, FDA, Medical laboratory scientist, Food, Pharmaceutical industry

MANCHESTER, N.H., March 18, 2024 (GLOBE NEWSWIRE) -- Sequel Med Tech, LLC, a company developing state-of-the-art insulin delivery technologies, today announced its partner, DEKA Research & Development Corp., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the innovative twiist™ Automated Insulin Delivery (AID) system powered by Tidepool.

Key Points: 
  • MANCHESTER, N.H., March 18, 2024 (GLOBE NEWSWIRE) -- Sequel Med Tech, LLC, a company developing state-of-the-art insulin delivery technologies, today announced its partner, DEKA Research & Development Corp., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the innovative twiist™ Automated Insulin Delivery (AID) system powered by Tidepool.
  • The twiist AID system, which will be commercialized by Sequel Med Tech, LLC, is the first drug delivery system that directly measures the volume and flow of insulin delivered with every micro-dose.
  • “The clearance of the twiist AID system is a pivotal first step in Sequel’s quest to make day-to-day life easier for people with type 1 diabetes.
  • The twiist system was designed from the start to integrate with the latest available innovation, and it represents the next generation of insulin delivery,” said Kamen.

Allogene Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Update

Retrieved on: 
Thursday, March 14, 2024
Research, Kite Pharma, PIN, CLL, Disease, AID, Patient, EFS, Observation, Pivotal, Cancer, Renal cell carcinoma, Bank statement, News, RCC, Therapy, CRISPR, Projection, MRD, GAAP, Autoimmune disease, Cyclophosphamide, CD19, Pharmaceutical industry

These restated financial statements have no impact on the Company’s cash, cash equivalents and marketable investments, cash runway or business operations.

Key Points: 
  • These restated financial statements have no impact on the Company’s cash, cash equivalents and marketable investments, cash runway or business operations.
  • Research and development expenses were $54.7 million for the fourth quarter of 2023, which includes $7.0 million of non-cash stock-based compensation expense.
  • General and administrative expenses were $17.2 million for the fourth quarter of 2023, which includes $8.2 million of non-cash stock-based compensation expense.
  • Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update.

Allogene Therapeutics and Arbor Biotechnologies Announce Global Gene Editing Licensing Agreement to Support Advancement of Next-Generation Allogeneic CAR T Platform in Autoimmune Disease

Retrieved on: 
Tuesday, March 12, 2024
Development, Gene editing, AID, Patient, SAN, Research, Cancer, Research and development, Imagination, Therapy, CRISPR, Kite Pharma, Autoimmunity, Autoimmune disease, Pharmaceutical industry

“The potential for CAR T as a therapeutic option for autoimmune disease has captured the collective imagination of the scientific community,” said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene.

Key Points: 
  • “The potential for CAR T as a therapeutic option for autoimmune disease has captured the collective imagination of the scientific community,” said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene.
  • “Accordingly, this excitement created a new field for CAR T that has become quickly crowded, making differentiation key for future success.
  • Allogene’s first AID AlloCAR T investigational product is expected to enter Phase 1 clinical trials in early 2025.
  • “We look forward to our collaboration with Allogene as they leverage our extensive gene-editing technologies to develop novel, differentiated allogeneic CAR T therapeutics for autoimmune diseases.”

First Book and Ashoka Announce 15 Youth Challenge Winners in Time for Change Nationwide Initiative

Retrieved on: 
Thursday, March 28, 2024
Marvel, Friends, Face, Learning, AID, Social media, History, Child, Ubuntu, Audemars Piguet, First Book, Partnership, Education, Attention, Monster Beverage, Animal, Teaching, Organization, Library, Coffee, Knowledge, Kylie, Volunteering, Student, Survivor, STEM, Time for Change, Problem solving, Parent, Bee, E-commerce, Health, Freedom, Culture, Growth, Environment, Network, Empathy, DonorsChoose, School, Faculty, Life, Biodiversity, STEAM, Youth, Heart, Refugee

WASHINGTON, March 28, 2024 /PRNewswire/ --Today, First Book and Ashoka, leading organizations in educational equity and social entrepreneurship, have announced the 15 grand prize winners of the Time for Change Youth Challenge. Young changemakers from across the country will receive $1,000 grants for student-led solutions to improve their classrooms, schools, and communities. The Time for Change Youth Challenge is designed to spark transformative changemaking journeys in young people, with submissions ranging from kindergarten to 12th grade students looking to bring their innovative solution to life or expand an existing student-led initiative.

Key Points: 
  • WASHINGTON, March 28, 2024 /PRNewswire/ --Today, First Book and Ashoka, leading organizations in educational equity and social entrepreneurship, have announced the 15 grand prize winners of the Time for Change Youth Challenge .
  • The Youth Challenge builds on the success of the Time for Change: Dream, Act, Change Our World campaign, first launched by First Book and Ashoka in 2022 .
  • The initiative has since expanded internationally to inspire young people to become changemakers for their schools and communities.
  • The Youth Challenge demonstrates the eagerness of young people to make lasting change in their schools and classrooms.

United Brotherhood of Carpenters receives $4.8M from the Government of Canada to provide Apprentices with financial supports and wrap-around services, eliminating certain barriers and obstacles to their progress in training and completion of their certifi

Retrieved on: 
Tuesday, March 19, 2024
United Brotherhood, Government, Mentorship, AID, Partnership, Carpentry, Employment, Languages of Ethiopia, UBCJA, Tradesman, Regional Council, Indigenous peoples, Disability, Workforce development, Programmer, Person, Nursing

Developed and led by the United Brotherhood of Carpenters and Joiners of America (UBC) Canadian District, the program is focused on increasing the UBC's apprenticeship completion and retention rates.

Key Points: 
  • Developed and led by the United Brotherhood of Carpenters and Joiners of America (UBC) Canadian District, the program is focused on increasing the UBC's apprenticeship completion and retention rates.
  • The project is funded in part by the Government of Canada's Canadian Apprenticeship Strategy.
  • First-year apprentices, particularly those from equity deserving groups, may also be eligible for financial assistance from the program.
  • Working collaboratively, the advisory groups will provide expertise and guidance to regional mentorship coordinators as they implement the UBC's National Mentorship Program for apprentices.

Insulet’s Randomized Controlled Trial (OP5-003) Demonstrates Omnipod® 5 Automated Insulin Delivery System is Superior to Pump Therapy

Retrieved on: 
Friday, March 8, 2024
Research, General Health, Technology, Medical Devices, Other Manufacturing, Health Technology, Clinical Trials, Science, Biotechnology, Wearables, Mobile Technology, Health, Diabetes, Manufacturing, TIR, Dexcom, CGM, Doctor of Philosophy, Randomized controlled trial, MD, Treatment, Medical director, G6, AID, Intervention, Conference, ATTD, Safety, Hypoglycemia, Control, RCT, T1D, Corporation, DKA, Body mass index, Treatment and control groups, Pharmaceutical industry

The OP5-003 Trial results were presented at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Florence, Italy.

Key Points: 
  • The OP5-003 Trial results were presented at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Florence, Italy.
  • "Omnipod 5 continues to demonstrate impressive clinical outcomes for people with type 1 diabetes,” said Professor Renard.
  • The control group (n=62) continued to use their usual insulin pump with a Dexcom G6 CGM, while the intervention group (n=132) used Omnipod 5 with Dexcom G6.
  • In conclusion, this multi-national, RCT data demonstrates the superiority of the Omnipod 5 AID System compared to standard pump therapy with CGM and indicates that it should be offered as a first-line therapy for adults with type 1 diabetes.

Dexcom Showcases Leadership in AID and Power of Dexcom CGM in Type 2 Diabetes With New Data at ATTD

Retrieved on: 
Tuesday, March 5, 2024
Software, Health, Diabetes, Medical Devices, Health Technology, Wearables, Mobile Technology, Technology, Clinical Trials, Tandem, HCP, CGM, Apple Watch, G6, Diabetic ketoacidosis, AID, DXCM, G7, Hypoglycemia, GLP1, Conference, Type 2 diabetes, ATTD, Type 2, Patient, Insulin, Apple, Mortality, Pharmaceutical industry

Dexcom also announced data showcasing the significant benefits of CGM use for individuals managing Type 2 diabetes, along with groundbreaking evidence demonstrating a direct association between CGM use and reduced mortality in people with Type 1 and Type 2 diabetes.

Key Points: 
  • Dexcom also announced data showcasing the significant benefits of CGM use for individuals managing Type 2 diabetes, along with groundbreaking evidence demonstrating a direct association between CGM use and reduced mortality in people with Type 1 and Type 2 diabetes.
  • Globally, we’ve expanded access to Dexcom products by over 5 million people,” said Kevin Sayer, President, CEO, and Chairman of the Board at Dexcom.
  • Dexcom has continued to drive access to its pioneering real-time CGM technology, launching its best-in-class G7 sensor in 16 new markets since ATTD 2023.
  • Further demonstrating the value of AID systems powered by Dexcom CGM, Dexcom will showcase recently published evidence at ATTD 2024.

Insulet to Present Results from First Omnipod® 5 Randomized Controlled Trial (OP5-003) at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD)

Retrieved on: 
Tuesday, March 5, 2024
Health Technology, Diabetes, Manufacturing, Technology, Pharmaceutical, Other Consumer, General Health, Medical Devices, Clinical Trials, Wearables, Mobile Technology, Other Manufacturing, Science, Consumer, Health, Research, Real-World Evidence, Cloud, OBE, Adolescence, Doctor of Philosophy, Treatment, Medical director, Database, University, Hypoglycemia, Associate, AID, University of Liverpool, Standard of care, Data, Therapy, Insulin, Convention, Randomized controlled trial, CGM, Pathway, Use, Conference, MDI, Automation, Endocrinology, MD, DASH, ATTD, Medicare, University of Edinburgh, Edge Hill University, Corporation, Chairperson, Medical device

“We are thrilled to unveil the results of our inaugural randomized controlled trial with groundbreaking insights from international Omnipod 5 users,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director.

Key Points: 
  • “We are thrilled to unveil the results of our inaugural randomized controlled trial with groundbreaking insights from international Omnipod 5 users,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director.
  • It is the first Omnipod 5 randomized controlled trial to date, and the first time the system has been evaluated in participants living outside of the United States.
  • This presentation will take place on Thursday, March 7 at 12:00 p.m. CET and Friday, March 8 at 10:30 a.m. CET.
  • Insulet representatives will be available to provide Omnipod product demonstrations to conference attendees, offering healthcare professionals the chance to experience Omnipod DASH and Omnipod 5 first-hand.

New real-world data shows MiniMed™ 780G system sustains strong global performance, exceeding international targets for diabetes management

Retrieved on: 
Saturday, March 9, 2024
TIR, TITR, CGM, MD, Medtronic, AID, Cohort (statistics), Conference, ATTD, Health, Endocrinology, Therapy, DCCT

DUBLIN and FLORENCE, Italy, March 9, 2024 /PRNewswire/ -- Medtronic plc. (NYSE: MDT), a global leader in healthcare technology, today shared a robust set of new clinical and real-world evidence on the MiniMed™ 780G system from around the world including the largest set of data from early users in the United States. The data was presented at the 17th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Florence, Italy. These results build on the 3-year data published in Diabetes Technology & Therapeutics showing over 100,000 real-world users achieving a Time in Range (TIR) of 78% with the use of recommended optimal settings, outperforming international targets of 70% TIR.

Key Points: 
  • The data was presented at the 17th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Florence, Italy.
  • These results build on the 3-year data published in Diabetes Technology & Therapeutics showing over 100,000 real-world users achieving a Time in Range (TIR) of 78% with the use of recommended optimal settings, outperforming international targets of 70% TIR.
  • In an oral presentation, Dr. James Thrasher, MD, Founder, Arkansas Diabetes and Endocrinology Center, shared data on early real-world users with type 1 diabetes of the MiniMed™ 780G system in the U.S. (n=7,499).
  • This data reinforces that the determinant of choice for AID systems should be first and foremost the power of the algorithm."

Edgepark adding first-of-its kind, fully automated insulin delivery system to diabetes portfolio

Retrieved on: 
Tuesday, February 13, 2024
Diabetes, Dexcom, Urology, CGM, Stoma, RDN, LD, Physician, Sleep apnea, G6, AID, G7, Carb, Documentation, Health, Automation, Insulin, Patient, Disease, Type, Meal, Insurance, Pharmaceutical industry

TWINSBURG, Ohio, Feb. 13, 2024 /PRNewswire/ -- Edgepark announced today it is offering the newly launched Beta Bionics iLet Bionic Pancreas fully automated insulin delivery (AID) system as part of its comprehensive diabetes management solution portfolio. The iLet is the first and only system that does not require carbohydrate counting* and fully automates 100 percent of insulin doses. Designed for anyone six years of age and older living with Type 1 diabetes, it eliminates the traditional manual work previously involved with using an insulin pump.

Key Points: 
  • TWINSBURG, Ohio, Feb. 13, 2024 /PRNewswire/ -- Edgepark announced today it is offering the newly launched Beta Bionics iLet Bionic Pancreas fully automated insulin delivery (AID) system as part of its comprehensive diabetes management solution portfolio.
  • The iLet is the first and only system that does not require carbohydrate counting* and fully automates 100 percent of insulin doses.
  • "Edgepark is thrilled to offer the iLet as a first-of-its-kind device that uses automation to make diabetes simpler to navigate."
  • As with any insulin delivery system, users must also be able to load the insulin pump with insulin, insert an infusion set and troubleshoot when challenges occur.