Two Deaths Linked To Philips Recall of Heart Monitoring Software

A failure to properly route cardiac events has led Philips to recall its heart monitoring software that interprets ECG data. Multiple injuries and two deaths are associated with the problem.

Philips initiated a recall in November of a software application from its subsidiary Braemar Manufacturing after identifying failures to properly route some electrocardiogram (ECG) events.

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Research Finds Benefit From DME Suppliers For People Living With Diabetes

 
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People living with diabetes who receive continuous glucose monitors (CGMs) through medical supply firms show higher compliance, lower costs of care, and fewer hospitalizations after one year than those who use pharmacies, a new study shows.

EU Commissioner: Medtech Regulations Assessment To Wrap Up by End 2025

 

Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.

Owlstone Medical Develops P.aeruginosa Breath Test For Cystic Fibrosis Patients

 

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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.

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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.

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.

One Death Linked To Calyxo Urological System

 

The US FDA has issued an early alert about the CVAC system from Calyxo, which urologists use in removing urinary stones.