CGM

Stelo by Dexcom First Glucose Biosensor to be Cleared by FDA as Over-the-Counter

Retrieved on: 
Tuesday, March 5, 2024
Software, Health, FDA, Diabetes, Medical Devices, Health Technology, Wearables, Mobile Technology, Technology, CGM, Continuity, Multimedia, MD, DXCM, A1C, Type 2 diabetes, Stelo, Type 2, Smartphone, Insulin, Glucose, Insurance, Dietary supplement

DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time continuous glucose monitoring for people with diabetes, announced today that the FDA has cleared Stelo by Dexcom – the first glucose biosensor that doesn’t require a prescription.

Key Points: 
  • DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time continuous glucose monitoring for people with diabetes, announced today that the FDA has cleared Stelo by Dexcom – the first glucose biosensor that doesn’t require a prescription.
  • There are approximately 25 million people in the U.S. living with Type 2 diabetes who do not use insulin and who can benefit from continuous glucose monitoring (CGM) technology.
  • Today, Dexcom G7 is available for them with a prescription.
  • To learn more about Stelo and do a benefits check to see if you’re eligible to get started now with Dexcom G7, visit https://www.dexcom.com/en-us/stelo .

Senseonics Holdings, Inc. Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, February 29, 2024
Diabetes, Health, Medical Devices, Total, Research, CGM, Doctor of Philosophy, Investment, Telephone, Marketing, FDA, Growth, PHC, Conference, Medicare, Patient, Data analysis, Acceleration, Clinical trial, Eastern Time Zone, UnitedHealth Group, Pharmaceutical industry

U.S. revenue was $6.1 million in the fourth quarter of 2023 compared to $3.6 million in the prior year period, and revenue outside the U.S. was $1.9 million in the fourth quarter of 2023 compared to $2.0 million in the prior year period.

Key Points: 
  • U.S. revenue was $6.1 million in the fourth quarter of 2023 compared to $3.6 million in the prior year period, and revenue outside the U.S. was $1.9 million in the fourth quarter of 2023 compared to $2.0 million in the prior year period.
  • Fourth quarter 2023 gross profit of $1.1 million increased from $0.6 million for the fourth quarter of 2022.
  • Fourth quarter 2023 sales and marketing and general and administrative expenses decreased by $0.5 million year-over-year, to $7.3 million.
  • Fourth quarter 2023 research and development expenses decreased by $0.9 million year-over-year, to $10.7 million.

Know Labs Announces the KnowU™, its Wearable Non-Invasive Continuous Glucose Monitor

Retrieved on: 
Tuesday, February 27, 2024
Consumer Electronics, Technology, Diabetes, Health, General Health, Wearables, Mobile Technology, Health Technology, Medical Devices, Research, Science, Hardware, Algorithm, Know Labs, CGM, Multimedia, FDA, Quality of life, Dielectric spectroscopy, Data collection, Prevalence, IP, Glucose, RF, Wrist, Forearm, Medical device

Know Labs , Inc. (NYSE American: KNW), an emerging developer of non-invasive medical diagnostic technology, today announced the KnowU™, its wearable non-invasive continuous glucose monitor (CGM).

Key Points: 
  • Know Labs , Inc. (NYSE American: KNW), an emerging developer of non-invasive medical diagnostic technology, today announced the KnowU™, its wearable non-invasive continuous glucose monitor (CGM).
  • The KnowU brings Know Labs closer to delivering the world’s first non-invasive blood glucose monitor to the global marketplace.
  • It records voltage values detected at each frequency to quantify, with trade-secret machine learning algorithms, real-time continuous blood glucose levels.
  • During 2024, Know Labs will deploy the KnowU in large-scale, external clinical trials while making refinements to the device and its algorithms.

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."

Real-World Data Show Abbott's FreeStyle Libre® Systems and GLP-1 Medicines Work Better Together for People with Type 2 Diabetes

Retrieved on: 
Wednesday, March 6, 2024
CGM, Blood, Glucose meter, Treatment, Weight loss, Glycated hemoglobin, Food, Conference, Behavior, Type 2 diabetes, ATTD, Type 2, Smartphone, Patient, Insulin, Heart, Continuous glucose monitor, Appetite, Pharmaceutical industry

These findings were presented at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) held in Florence, Italy, on March 6, 2024.

Key Points: 
  • These findings were presented at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) held in Florence, Italy, on March 6, 2024.
  • GLP-1 medicines – also known as glucagon-like peptide-1 receptor agonist (GLP-1 RA) - are increasingly being prescribed for people with Type 2 diabetes as they provide glycemic benefit and support weight loss.
  • "While treating my patients, I've observed that when we've added a CGM, like the FreeStyle Libre technology, to their GLP-1 therapy, we see even better glycemic control.
  • To maximize the benefits of GLP-1 medicines, it's worth considering the combination of a CGM to support people who live with Type 2 diabetes."

FDA Clears First Over-the-Counter Continuous Glucose Monitor

Retrieved on: 
Tuesday, March 5, 2024
Human services, Diabetes, Dexcom, CGM, Cosmetics, Multimedia, Diet, Dietary supplement, Marketing, FDA, OTC, CDRH, Food, Pain, Exercise, Vaccine, Animal, Health, Infection, Safety, Heated tobacco product, Public, Patient, Insulin, Device, Health equity, Trial of the century, Irritation

SILVER SPRING, Md., March 5, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM).

Key Points: 
  • SILVER SPRING, Md., March 5, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM).
  • "CGMs can be a powerful tool to help monitor blood glucose.
  • The device presents blood glucose measurements and trends every 15 minutes in the accompanying app.
  • Data from a clinical study provided to the FDA showed that the device performed similarly to other iCGMs.

Clear Guide Medical Receives FDA Clearance for CLEAR GUIDE SCENERGY™ Device for Transperineal Interventions

Retrieved on: 
Tuesday, March 5, 2024
ClinicalTrials.gov, Needle, FDA, Biopsy, Prostate, Patient, Sepsis, Diagnosis, CGM, Mayo Clinic, Clinical professor, CLEAR, Risk, Medical imaging

CLEAR GUIDE SCENERGY is a state-of-the-art system that delivers remarkable accuracy to enhance image-guided diagnostic and interventional procedures.

Key Points: 
  • CLEAR GUIDE SCENERGY is a state-of-the-art system that delivers remarkable accuracy to enhance image-guided diagnostic and interventional procedures.
  • While we always believed it would have a profound impact on cancer screenings, the clinical results for transperineal interventions have been truly remarkable," says Clear Guide Medical CMO Dr. Nick Karahalios.
  • "This latest FDA clearance exemplifies our commitment to advancing medical technologies for the benefit of patients and healthcare professionals," says Clear Guide Medical COO Patrick Duke.
  • For transperineal biopsy procedures, the CLEAR GUIDE SCENERGY-TP allows clinicians to guide biopsy needles through the perineal skin into the prostate, minimizing the risk of contamination associated with transrectal biopsies.

SIBIONICS Announced to Exhibit at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD)

Retrieved on: 
Monday, February 19, 2024
CE, Hospital, Com, Glucose meter, CGM, International Fair, MDR, Treatment, Booth, GS1, Conference, Emerging technologies, ATTD, GS, Prediabetes, Certification, GS2, Q&A, DSM-IV codes

LOS ANGELES, Feb. 19, 2024 /PRNewswire/ -- SIBIONICS, the world's third-largest Continuous Glucose Monitoring (CGM) System brand, announced the company will be exhibiting at the International Fair of New Technologies in Diabetes at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Florence, Italy on 6-9 March 2024. The company will showcase its latest CGM solutions for diabetes management at Booth No.15 at the conference. According to SIBIONICS, it has collaborated with over 1,800 hospitals on integrating their CGM for inpatient treatment, benefiting over 850,000 individuals worldwide in managing diabetes. SIBIONICS is constructing an automated production line with an annual capacity of 18 million CGM sets, expected to be completed within 2024.

Key Points: 
  • LOS ANGELES, Feb. 19, 2024 /PRNewswire/ -- SIBIONICS, the world's third-largest Continuous Glucose Monitoring (CGM) System brand, announced the company will be exhibiting at the International Fair of New Technologies in Diabetes at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Florence, Italy on 6-9 March 2024.
  • The company will showcase its latest CGM solutions for diabetes management at Booth No.15 at the conference.
  • According to SIBIONICS, it has collaborated with over 1,800 hospitals on integrating their CGM for inpatient treatment, benefiting over 850,000 individuals worldwide in managing diabetes.
  • SIBIONICS is constructing an automated production line with an annual capacity of 18 million CGM sets, expected to be completed within 2024.

SIBIONICS Announced to Exhibit at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD)

Retrieved on: 
Monday, February 19, 2024
CE, Hospital, Com, Glucose meter, CGM, Multimedia, International Fair, MDR, Treatment, Booth, GS1, Conference, Emerging technologies, ATTD, GS, Prediabetes, Certification, GS2, Q&A, DSM-IV codes

LOS ANGELES, Feb. 18, 2024 /PRNewswire/ -- SIBIONICS, the world's third-largest Continuous Glucose Monitoring (CGM) System brand, announced the company will be exhibiting at the International Fair of New Technologies in Diabetes at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Florence, Italy on 6-9 March 2024. The company will showcase its latest CGM solutions for diabetes management at Booth No.15 at the conference. According to SIBIONICS, it has collaborated with over 1,800 hospitals on integrating their CGM for inpatient treatment, benefiting over 850,000 individuals worldwide in managing diabetes. SIBIONICS is constructing an automated production line with an annual capacity of 18 million CGM sets, expected to be completed within 2024.

Key Points: 
  • LOS ANGELES, Feb. 18, 2024 /PRNewswire/ -- SIBIONICS, the world's third-largest Continuous Glucose Monitoring (CGM) System brand, announced the company will be exhibiting at the International Fair of New Technologies in Diabetes at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Florence, Italy on 6-9 March 2024.
  • The company will showcase its latest CGM solutions for diabetes management at Booth No.15 at the conference.
  • According to SIBIONICS, it has collaborated with over 1,800 hospitals on integrating their CGM for inpatient treatment, benefiting over 850,000 individuals worldwide in managing diabetes.
  • SIBIONICS is constructing an automated production line with an annual capacity of 18 million CGM sets, expected to be completed within 2024.

Senseonics Holdings, Inc. Schedules Fourth Quarter and Full Year 2023 Earnings Release and Conference Call for February 29, 2024 at 4:30 P.M. Eastern Time

Retrieved on: 
Thursday, February 15, 2024
Diabetes, Health Technology, Health, Medical Devices, Eastern Time Zone, International, Publication, CGM, Webcast

Management will hold a conference call to review the Company’s fourth quarter and full year 2023 performance starting at 4:30 p.m. (Eastern Time) on the same day.

Key Points: 
  • Management will hold a conference call to review the Company’s fourth quarter and full year 2023 performance starting at 4:30 p.m. (Eastern Time) on the same day.
  • The conference call will be concurrently webcast.
  • The link to the webcast will be available on Senseonics Holdings, Inc. website at www.senseonics.com by navigating to “Investor Relations,” and then “Events & Publications,” and will be archived there for future reference.
  • To listen to the conference call, please dial 1-888-317-6003 (US/Canada) or 1-412-317-6061 (International), passcode 3711982, approximately ten to five minutes prior to start time.