Diabetic Care

News We’re Watching: FDA Recalls Communication Pilot; Cardinal Buys Two Firms; Medtronic Diabetes App Cleared

This week, the US device center announced a pilot program to speed communications about high-risk recalls; Cardinal paid $3.9B for Advanced Diabetes Supply Group and GIA Alliance; a companion diagnostic for Merck lung cancer drug Tepmetko got FDA clearance; and more.

Abbott Opens New Manufacturing Facility In Ireland For FreeStyle Libre 3 Production

 
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Abbott is celebrating the opening of its new manufacturing facility in Ireland for diabetes care.

GlucoModicum’s Magnetohydrodynamic CGM Platform Moves Closer To The Clinic

 
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The company has taken the ambitious approach of establishing a manufacturing base capable of producing millions of devices before any attempt at a regulatory submission.

Beta Bionics Launches iLet Bionic Pancreas With Abbott’s Latest-Generation CGM

 
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Beta Bionics’ automated insulin delivery system is now pairable with Abbott’s FreeStyle Libre 3 Plus CGM.


Passing The Torch: Tarver Addresses Audience At FDA Town Hall, Recognizes Shuren’s Accomplishments

 

In her inaugural address to the medtech industry during the Medtech Conference, acting US CDRH director Michelle Tarver described her mission-driven approach.

News We’re Watching: Trial Lab Warning Letters, Novartis Adds US Plants, Abbott Launches OTC Lingo Glucose Monitor

 

This week, two device testing labs in China landed FDA warning letters; refunds for 1Health.io clients; FDA AR/VR product list expands. 

LSX Medtech Panelists Talk AI, Market Access Strategies, Digital Therapeutics Reimbursement

 
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Highlights from Medtech Insight's on-the-ground coverage of LSX in Boston. 

News We’re Watching: $1B Judgement Against J&J Recalls For Abbott, Baxter, More; Karl Storz Announces Fujifilm Partnership

 

This week, a Delaware court awarded Auris Health shareholders $1bn in a lawsuit against Johnson & Johnson; Abbott recalled some FreeStyle Libre 3 sensors; and McKesson purchased a controlling interest in a Florida cancer care chain.


Dexcom’s Stelo CGM Now Available Without Prescription In US

 

Dexcom announced the launch of Stelo, the first non-prescription continuous glucose monitoring system to hit the US market, but is likely going to face competition soon from Abbott.

Tandem’s Mobile App Still Causing Battery Depletion Post-Update

 
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Despite a March recall and a following update, Tandem’s t:slim X2 application is still causing the battery-depleting defect.

Medtronic Plugs ‘Biggest Hole’ In Diabetes Platform With Surprise Abbott Deal – Analyst Reactions

 
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Medtronic and Abbott announced partnership to integrate Abbott’s CGM sensor with Medtronic’s insulin pump, which marks a major departure from Medtronic’s former “closed-system” approach. Medtronic also announced FDA clearance of its Simplera CGM, paving the way for its use in smartpens.

Medway NHS Trust Partners With Digostics To Launch At-Home Gestational Diabetes Test

 

Medway NHS Foundation Trust joined forces with Digostics to offer home oral glucose tolerance testing for pregnant women at risk of gestational diabetes. 


Abbott Issues Correction On Faulty Glucose Monitors

 

Abbott has issued an urgent voluntary medical device correction for a small number of FreeStyle Libre 3 sensors distributed in the US during May. The sensors could give inaccurate readings, the company explained.

Biolinq Aims To Transform Diabetic Glucose Monitoring With Needle-Free Patch

 
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Biolinq’s CEO Rich Yang spoke to Medtech Insight about the company’s wearable patch in development, which uses tiny microsensors to measure, for now, glucose, with ample runway for additional indications down the line. If approved by the US FDA, the device would become the first of its kind to monitor glucose levels in diabetes patients not using insulin.

Digital Health Roundup: Brain Talk On Seizures, Alzheimer's, Stress, Anxiety; Medtronic's OR Report; Health Care AI; UK Guidances

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights AI discussions at the HLTH Europe conference and an interview with Motif Neurotech's CEO Jacob Robinson. Elizabeth Orr discusses DeepWell DTx's newly launched VR game for treating stress-related hypertension and anxiety. Natasha Barrow provides an overview of Digital Mental Health Technologies regulation in the UK and Brian Bossetta reports ‘the good and bad’ from Medtronic's report on digital technologies' use in the operating room.     

‘Is This Doomsday Concern, Or Is It Reality?’ Verily CMO On AI’s Future, Lightpath Metabolic, More

 
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Andrew Trister, Verily’s chief medical and scientific officer, spoke with Medtech Insight at the HLTH Europe conference about Verily’s newly launched Lightpath Metabolic solution, featuring GLP-1 prescription, AI and strengthened clinical support. Trister also talked about plans for the Study Watch and offered views on the Alzheimer’s research landscape and AI development and regulation in a new era of uncertainty.


News We’re Watching: Boston Sci Buys Silk Road Medical; EOFlow Injunction Blocked; LDT Compliance Dates Announced

 

This week, Boston Scientific agreed to pay $1B+ for stroke prevention device firm Silk Road Medical; the FDA asked for feedback on patient safety for non-device medical software; and a former medtech CEO was sentenced to six years for her part in a phony device scheme.

News We’re Watching: DMCA Judicial Review Upheld; Abbott’s Rio CGM Available OTC; J&J’s Velys Wins FDA UKA Expansion

This week, AdvaMed and MITA win appeal to prevent repair companies from hacking medical devices, the FDA cleared Abbott’s Libre Rio CGM for OTC sales, J&J MedTech wins expanded clearance for Velys knee medical robot, the FDA updates its AI program, Canary Speech secures $13m in series A funding and Xeltis won FDA approval for an IDE submission to begin enrolling patients for a pivotal study for aXess.  

Twin Health Extends AI-Powered Program To Help Healthy People Sustain Weight Loss Without GLP-1

 
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Twin Health extends its whole-body digital twin AI platform to help people who are overweight or obese achieve a healthy weight without the use of medications.

Dexcom Announced Launch Of One+ CGM In UK, State Of Type 2 Report

 
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Dexcom launches its highly customizable One+ continuous glucose monitor in the UK as well as a state of type 2 report that suggests 63% of people living with type 2 diabetes have trouble managing their disease.