New Frontier: COVID-19 Crisis Opens Door For Dexcom, Abbott To Bring CGMs Into Hospitals For First Time

Dexcom and Abbott’s permission by US regulators to bring their continuous glucose monitoring devices directly to hospitals for remote monitoring of COVID-19 patients could open up a new market opportunity post-pandemic.

DexcomG6 Full Family

The US Food and Drug Administration has given Dexcom Inc. and Abbott Laboratories Inc. permission to bring their continuous blood glucose monitoring (CGM) systems into hospitals during the COVID-19 pandemic.

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US FDA Should Regulate ‘Dangerous’ Prescription Software Platform As A Medical Device, Says Patient Advocacy Group

The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.

23andMe Files For Bankruptcy, Raising Fresh Concerns Over Fate Of Genetic Data

23andMe has filed for Chapter 11 bankruptcy and announced the resignation of founder and CEO Anne Wojcicki. Privacy concerns surrounding the sale of its extensive genetic database remain after a 2023 data breach exposed data from some 7 million users. Experts warn that bankruptcy proceedings could lead to consumer data being sold, raising questions about legal protections and consumer rights.

European Medicine Agency’s CHMP Qualifies First AI Tool For Use In Clinical Trials

 

With the support of AIM-MASH AI Assist only one pathologist is needed to reliably make a histology assessment of inflammatory liver disease to decide whether patients should be included in MASH clinical trials.

Barcelona’s S2 Xpeed Accelerates Hardware-Based Medtech Start-Ups From Prototype To Market

 
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Barcelona-based accelerator S2 Xpeed is driving the rapid growth of medtech and hardware start-ups in Europe. Operating under a "sweat equity" model, the program helps early-stage companies move from prototype to manufacturing readiness in exchange for equity. This month, the accelerator will add a fourth cohort of 10 more start-ups, five of which are in the medtech space.

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Urine Test Could Halve Number Of CT Scans For Patients With Kidney Cancer

 

The urine-based GAGome test showed promise in the first clinical results from the international AURORAX-0087A, in the largest study conducted on clear cell renal cell carcinoma, the most common type of kidney cancer.

Roche’s Bet On Next-Gen Sequencing Poses New Challenge For Illumina’s Market Dominance

 
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Roche Diagnostics CEO Matthew Sause tells Medtech Insight about how the technology addresses the pricing challenges for mid- and low-throughput customers.

New CLIA Rule Updates Personnel Policies

 
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A new set of clinical lab regulations, which came into effect in January, include higher fees, an expanded set of possible consequences for labs that are not in compliance, and revised employee standards.