Medical Device Developments Weekly
Medical Device Developments
Latest news and insight on innovations in the Medical Device sector.
Welcome to this week's Medical Device Developments newsletter.
See the latest insight and analysis from the global medical device market from the last week below:
Fitbit (now part of Google) & Quest Diagnostics to assess potential of wearables in metabolic health
The collaboration is intended to assess the combination of the two companies’ products in improving metabolic health, which is linked to several diseases like heart disease and diabetes.
The pilot study, dubbed Wearables for Metabolic Health (WEAR-ME), will combine behavioural and biometric data from Fitbit devices with health insights from Quest Diagnostics’ laboratory tests.
According to Quest Diagnostics, the trial will explore ways data can be combined and analysed to enhance the assessment and management of metabolic health and help to inform in preventing disease.
Quest Diagnostics and Fitbit (now part of Google) joint pilot study aims to determine how wearables affect users’ actions as determined by objective test findings from laboratories.
Abbott secures expanded FDA approval for Proclaim DRG neurostimulation system
The expanded FDA approval allows the Proclaim DRG neurostimulation system to provide full-body MRI scans of patients, while they are implanted with the device.
Abbott said that its Proclaim is the only FDA-approved DRG technology to provide targeted relief for people with complex regional pain syndrome (CRPS) types 1 and 2 of the lower limbs.
CRPS is a rare and painful condition characterised by a continuous or intermittent burning, stinging or tearing sensation and has been found to be more excruciating than childbirth or amputation of a limb.
DermaSensor, Inc. gets FDA nod for AI-powered skin cancer detection device
DermaSensor, Inc. gets FDA nod for AI-powered skin cancer detection device.
The device leverages spectroscopy technology and an AI-powered algorithm to help identify the presence of cancer.
It provides primary care physicians (PCPs) with immediate, accurate, and objective results for skin cancer detection through data-driven breakthrough technologies.
The device allows the care providers to evaluate cellular and subcellular changes to better identify skin cancers before they progress, said the health technology company.
Dexcom begins construction on €300m manufacturing site in Athenry, Ireland
The plant is being built in Athenry in County Galway with an investment of €300m over five years.
Athenry was announced as the site for the plant in May 2023.
Expected to generate over 1,000 jobs to the region, the facility marks one of the largest single private sector investments to be made so far in the West of Ireland.
Set to become the first manufacturing site in Europe for Dexcom, the Irish facility will bolster product distribution across Europe, the Middle East, and Africa (EMEA). This will potentially reduce the cost of goods and enhance sustainability by shortening delivery transit times.
The Irish government, through IDA Ireland, is lending support to the project.
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Clarius Mobile Health secures CE mark for Clarius PAL HD3 wireless ultrasound scanner
Clarius Mobile Health secures CE mark for Clarius PAL HD3 wireless ultrasound scanner.
The system is a dual-array ultrasound scanner that combines phased and linear arrays on a single head, to offer superior-quality images of superficial and deep anatomy at the bedside.
The Clarius PAL HD3 wireless scanner is designed to be as compact as an iPhone and works with iOS or Android devices, facilitating easy mobility from patient to patient.
Also, it is the only whole-body handheld scanner that delivers high-resolution images from the skin down to 40cm of depth and is currently available in Europe and the UK, said Clarius.
Reflow Medical secures CE mark for Bare temporary spur stent system
Reflow Medical secures CE mark for Bare temporary spur stent system.
The Bare temporary spur stent system is a unique clinical solution, known as Retrievable Stent Therapy (RST), which provides stent-like results while leaving no metal behind.
It is a self-expanding stent, designed with radial spikes to create channels in the vessel wall to enhance drug absorption and reduce recoil.
The system, together with a commercially available drug-coated balloon (DCB), is indicated for the treatment of restenotic lesions in the infrapopliteal arteries to enhance drug absorption.
Modular Medical, Inc. seeks FDA 510(k) clearance for MODD1 insulin pump
Modular Medical, Inc. created the MODD1 using new microfluidics technology to enable inexpensive insulin pumping.
The 90-day reusable and three-day consumable product is said to be easy to use and prescribe due to its new, intuitive design.
According to Modular Medical, Inc., the pump has a 300 unit/3 mL reservoir which is equal to other insulin pumps?in the US market.
The device also has a red, yellow and green light system that indicates the status of its operations.
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Until next year.
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