Medical Device Developments Weekly

Medical Device Developments Weekly

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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:


Wellvii Inc and B-Secur partner on BP and heart health monitoring device

? Wellvii Inc and B-Secur partner on BP and heart health monitoring device

Wellvii has developed the BP Go Rhythm device that records blood pressure from the finger. The US Food and Drug Administration (FDA)-cleared product is designed to replace the traditional NIBP arm cuff.

According to Wellvii, the device will increase convenience, comfort, and portability than existing devices. It will also transform ambulatory, remote patient monitoring, and home monitoring.

Furthermore, using Bluetooth and cellular IoT connectivity, the device will offer easy data sharing for enhanced patient care worldwide.

Read more online: https://lnkd.in/ebT4YJTp

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Wellvii has developed the BP Go Rhythm device that records blood pressure from the finger. The US Food and Drug Administration (FDA)-cleared product is designed to replace the traditional NIBP arm cuff.

According to Wellvii, the device will increase convenience, comfort, and portability than existing devices. It will also transform ambulatory, remote patient monitoring, and home monitoring.

Read more


OrthAlign, Inc. secures FDA 510(k) approval for Lantern Hip navigation system

?? OrthAlign, Inc. secures FDA 510(k) approval for Lantern Hip navigation system

Lantern Hip technology is designed to support direct anterior total hip arthroplasty with the patient in the supine position.

It is the latest addition to the Lantern platform, which comprises other applications for total knee, revision knee, and partial knee arthroplasty.

According to the company, Lantern Hip fits into normal surgical workflow, without needing any extra time, equipment, workflows, or processes.

Read more online: https://lnkd.in/eyk3dwir

?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

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Lantern Hip technology is designed to support direct anterior total hip arthroplasty with the patient in the supine position.

It is the latest addition to the Lantern platform, which comprises other applications for total knee, revision knee, and partial knee arthroplasty.

Read more


BioIntelliSense, Inc secures FDA approval for BioButton and BioDashboard

?? BioIntelliSense, Inc secures FDA approval for BioButton and BioDashboard

BioButton is a rechargeable and reusable inpatient solution, which is said to expand the company’s continuous patient monitoring solutions portfolio.

It enables automating vital sign collection across medical-surgical units, speciality care areas, and emergency departments and delivers hospital-level care at home.

The BioDashboard clinical intelligence system offers a data-driven exception management feature that enables scalable, automated trending notifications personalised for each patient.

Read more online: https://lnkd.in/ejZPeXbH

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hashtag#MedicalDeviceDevelopments hashtag#medicaldevices hashtag#medicalmanufacturing

BioButton is a rechargeable and reusable inpatient solution, which is said to expand the company’s continuous patient monitoring solutions portfolio.

It enables automating vital sign collection across medical-surgical units, speciality care areas, and emergency departments and delivers hospital-level care at home.

Read more


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The authoritative voice of the medical device industry, Medical Device Developments is leading the debate on the evolution of the market through extensive research, data analysis, policy reports and up-to-the-minute reporting from the medical device industry.

Medical Device Developments is the premier information source for the world’s major medical device manufacturers/OEMs to help them make critical business decisions.

Aimed at senior executives, Medical Device Developments provides a clear overview of the latest thinking regarding the role of technology.

Medical Device Developments is supported across a number of platforms online and is positioned as the definitive destination for medical device manufacturing professionals. We are driven by unbiased and authoritative editorial content brought to you by an expert team of journalists with unrivalled industry expertise.

Study demonstrates superiority of Kerecis fish-skin for diabetic foot ulcer treatment

?? Study demonstrates superiority of Kerecis fish-skin for diabetic foot ulcer treatment

The study is by far the largest randomized controlled trial (RCT) of its kind because of the number of patients and severity of the wounds studied (University of Texas grades 2 and 3). 

The findings underscore the efficacy of fish-skin grafts in the treatment of diabetic foot ulcers (DFU), offering new hope and improved outcomes for patients.

Key Study Findings:
Significantly higher healing rates: At 16 weeks, 44% of DFUs treated with Kerecis Fish-skin Grafts had healed, compared with 26.4% using SOC (p<0.001).

Sustained superiority: This trend continued, with 55.2% of fish-skin graft-treated wounds healed at 24 weeks versus 37.8% for standard care.

Faster healing: In the study, diabetic foot ulcers treated with intact fish-skin graft were associated with faster wound closure time, with the wounds healing approximately two weeks earlier and with a 1.6x (95% CI: 1.07 – 2.36) greater chance of w

The study is by far the largest randomized controlled trial (RCT) of its kind because of the number of patients and severity of the wounds studied (University of Texas grades 2 and 3).

The findings underscore the efficacy of fish-skin grafts in the treatment of diabetic foot ulcers (DFU), offering new hope and improved outcomes for patients.

Read more


Medinol completes first-in-human use of ChampioNIR stent in Australia

? Medinol completes first-in-human use of ChampioNIR stent in Australia

The first-in-human implantations were carried out by surgeons Dr Gerard Goh and Dr Thodur Vasudevan of the Alfred Hospital in Melbourne Australia.

The ChampioNIR stent system combines a highly deliverable, and virtually un-fracturable stent that delivers the drug to every millimetre of the vessel surface.

It comes with a self-expanding nitinol radial structure for enhanced flexibility and fracture resistance, and polymeric coating for tensile strength for precise implantation and drug delivery.

Read more online: https://lnkd.in/e_z2bMx6

?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

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The first-in-human implantations were carried out by surgeons Dr Gerard Goh and Dr Thodur Vasudevan of the Alfred Hospital in Melbourne Australia.

The ChampioNIR stent system combines a highly deliverable, and virtually un-fracturable stent that delivers the drug to every millimetre of the vessel surface.

Read more


FDA grants Breakthrough Device designation to Amphix Bio, Inc. Bio’s bone regeneration product

???♂? FDA grants Breakthrough Device designation to Amphix Bio, Inc. Bio’s bone regeneration product

The designation covers the use of the therapeutic device to treat degenerative disc disease with transforaminal lumbar interbody fusion (TLIF) procedures.

The Breakthrough Devices Program is intended to accelerate the development, assessment, and review of new medical devices or drug-device combination products for more effective treatment of debilitating diseases or conditions.

This is the first product based on supramolecular peptide amphiphiles — Amphix Bio’s core technology platform — to be evaluated by the agency. 

Read more online: https://lnkd.in/ecYndfkr

?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

#MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

The designation covers the use of the therapeutic device to treat degenerative disc disease with transforaminal lumbar interbody fusion (TLIF) procedures.

The Breakthrough Devices Program is intended to accelerate the development, assessment, and review of new medical devices or drug-device combination products for more effective treatment of debilitating diseases or conditions.

Read more


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ATL Technology offers complete medical device solutions from concept to market, including design and development, prototyping, testing, regulatory compliance, and high-volume finished medical device manufacturing. With capabilities in catheter extrusion, braided shaft manufacturing, injection molding, wire and cable extrusion, and SMT/PCBA, we support complex medical sub-assemblies and finished devices. Our services include full automation, packaging, sterilization, and global sourcing, providing a vertically integrated approach that accelerates innovation while ensuring the highest quality standards.

Thanks for reading; we hope you enjoyed it.

Until next week.

To have a story featured on next week's newsletter - contact Medical Device Developments or Jamie Mann directly.

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