Medical Product Outsourcing

FDA Approves Continuation of Senseonics Study on Glucose Monitoring System

Thirty-five participants will now be monitored for a total of 365 days.

Business Wire 04.29.20

AptarGroup Seeking Emergency Authorization for Easy Mask Disinfection Process

Process takes three hours and can be performed on-site at hospitals.

AptarGroup Inc. 04.17.20

Dexcom and DreMed Diabetes Forge Data Partnership Agreement

Collaboration enables Dexcom CGM users in the U.S. to seamlessly use DreaMed’s Advisor Pro platform for optimal patient insulin therapy management.

Business Wire 04.16.20

Chronic Disease | Patient Monitoring

FDA OKs Abbott's FreeStyle Libre CGM Use in Hospitals

Remotely monitors patients with diabetes to minimize exposure to COVID-19.

PR Newswire 04.08.20

Digital Health

Digital Defenders: COVID-19 Creates a Spotlight on Digital Health Tools

Digital health tools like telemedicine, AI algorithms, and connectivity are playing an increasingly important role in helping prevent and manage disease.

Michael Barbella, Managing Editor 04.01.20

Senseonics Partners With Companion Medical on Diabetes Management

Eversense long-term CGM and InPen System to integrate sensor glucose and insulin data.

Business Wire 04.01.20

Moody's: Medical Device Earnings Forecast Decreased Based on Lower Sales

Companies will increase investment in research and development in order to maintain or enhance revenue growth.

Moody's Investors Service 03.18.20

Chronic Disease

Dexcom's G6 CGM System Gains CE Mark for Use by Pregnant Women

Poorly controlled glucose levels in pregnant women with Type 1, Type 2 or gestational diabetes can lead to serious problems for the mother and child.

Business Wire 02.24.20

Chronic Disease

Abbott, Insulet Partner on Automated Insulin Delivery System

Combining Abbott's glucose sensing technology with Insulet's next-generation tubeless system.

Abbott Laboratories 02.19.20

FDA Clears t:slim X2 Insulin Pump With Advanced Hybrid Closed-Loop Technology

Automated insulin dosing software is the first to receive new classification by the agency.

Business Wire 02.03.20

Chronic Disease | Patient Monitoring

Noninvasive Spectroscopy Could Monitor Blood Glucose

MIT study hopes to make needle pricks for diabetics a thing of the past.

Anne Trafton, MIT News Office 01.27.20

Chronic Disease | Patient Monitoring

Mobile App Allows Diabetics to Avoid Blood Fingerstick Testing

Patients can now make treatment decisions without having to test their blood glucose levels.

Business Wire 01.24.20

Patient Monitoring

Tandem Diabetes Launches New Version of Insulin Pump in U.S.

It is the first and only system cleared to deliver automatic correction boluses in addition to adjusting insulin.

Business Wire 01.16.20

Integrity Applications Co-Founder Takes on New Role

The man who helped establish the company is now its president.

Globe Newswire 01.13.20

Patient Monitoring

FDA OKs UVA-Developed 'Artificial Pancreas'

Device automatically regulates blood glucose for type 1 diabetes patients.

University of Virginia Health System 01.02.20

Patient Monitoring | Software & IT

Roche's Blood Glucose Reading Smartphone App Gains CE Mark

The app determines blood glucose ranges by taking photos with the smartphone camera without the need for a blood glucose meter.

GlobeNewswire 12.10.19

Patient Monitoring | Software & IT

Meal-Detection Tech Brings 'Artificial Pancreas' One Step Closer to Reality

Meal-detection technology allows insulin to be administered automatically with unprecedented speed and accuracy.

Stevens Institute of Technology 11.12.19

Senseonics Completes U.S. Patient Enrollment in PROMISE 180-Day Sensor Clinical Study

Trial is intended to evaluate the safety and efficacy of the Eversense CGM System in people with diabetes over a 180-day period.

Business Wire 11.11.19

Dexcom CFO Promoted to Chief Operating Officer

New COO had been chief financial officer since 2017.

Business Wire 10.29.19

Fortune 100 Executive Joins DexCom's Board

New member worked for Merck and J&J, among other large firms.

Business Wire 10.28.19

Patient Monitoring

Pacifier Biosensor Could Help Monitor Newborn Health

It could ultimately help diagnose and treat diabetes in the smallest of patients.

American Chemical Society 10.25.19

Artificial Pancreas System Outperforms Current Technology in New Study

Research shows the safety, efficacy and benefits of new system.

National Institutes of Health 10.17.19

Patient Monitoring

Abbott & Tandem Diabetes Care to Integrate Products

Companies aim to integrate Abbott's FreeStyle Libre glucose sensing with Tandem's insulin delivery products to expand choices for people with diabetes.

Abbott Laboratories 10.15.19

Digital Health | Patient Monitoring | Software & IT

Abbott and Omada to Develop Type 2 Diabetes Digital Coaching Platform

The solution will combine Abbott's FreeStyle Libre CGM with Omada's digital care program.

Abbott Laboratories 10.14.19

Patient Monitoring

FDA OKs Dexcom G6 Pro CGM

It is the first and only single-use, professional CGM system with blinded or unblinded mode.

Business Wire 10.08.19

Patient Monitoring

Medtronic Introduces Envision Pro CGM System in Europe

Combines valuable data with optimal user experience.

Medtronic 09.17.19

Diagnostics | Patient Monitoring

Medtronic and Novo Nordisk Enter Agreement

Will provide integrated digital solutions for people with diabetes.

Medtronic 09.16.19

Medtronic Approved to Start Trial of Extended Wear Infusion Set

Addresses patient burden with convenient features for insulin pump therapy.

Medtronic plc. 08.19.19

Digital Health

Insulet Corporation Launches Apps

Mobile apps now available for iOS devices.

Business Wire 08.14.19

2. Johnson & Johnson

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07.30.19

20. Terumo

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07.30.19

Cardiovascular

Itamar Medical and BioTel Heart Expand Collaboration

Collaboration designed to integrate sleep apnea management into cardiology care pathways.

Globe Newswire 07.19.19

Diagnostics | Patient Monitoring

Taiwan Aims to Boost Sales in U.S. Market with New Cost-Saving Medical Devices

Medical inventions promote smart technology and minimally invasive surgery.

Taiwan Excellence 07.11.19

Glytec Awarded Patent Allowance for Virtual Insulin Titration in Concert With CGM and Smart Pens

Company's digital platform offers primary care providers the means to use CGM data to formulate timely and discrete dosing recommendations.

Business Wire 07.05.19

Patient Monitoring

FDA Warning: Potential Cybersecurity Concerns with Certain Medtronic Insulin Pumps

The recalled pumps are Medtronic’s MiniMed 508 insulin pump and MiniMed Paradigm series insulin pumps.

FDA 06.28.19

New Non-Invasive Glucose Monitor Set to Disrupt Wearable Health Tech Space

The world’s first non-invasive continuous glucose monitor, SugarBEAT, is set to disrupt wearable health tech space, says GlobalData.

GlobalData 06.13.19

Electronics | Patient Monitoring

Medtronic Begins Pivotal Trial for Next-Gen Guardian CGM Sensor

The next-gen sensor aims to improve accuracy and overall system performance, reduce calibrations, and enhance overall user experience.

GlobeNewswire 06.10.19

Patient Monitoring

Medtronic & Tidepool Partner on Interoperable Automated Insulin Pump

The goal is a Bluetooth-enabled MiniMed pump compatible with Tidepool's automated insulin delivery app.

GlobeNewswire 06.10.19

Patient Monitoring

FDA OKs Non-Adjunctive Indication (Dosing Claim) for Senseonics' Eversense 90-Day CGM System

With a non-adjunctive claim, Eversense users will soon be able to manage their diabetes dosing decisions without confirming with fingersticks.

Business Wire 06.07.19

Patient Monitoring

FDA Warns Against Use of Unauthorized Diabetes Management Devices

FDA is aware patients may choose to create these systems or purchase unauthorized or unapproved components or systems because of personal preference or cost.

U.S. Food and Drug Administration 05.20.19