Latest updates for Medical Devices

Fresh curated links around Medical Devices are collected here so marketers can spot useful updates and turn timely ideas into posts faster.

Recent items include:

  • Medical Devices and Privacy by Design: A Way to DPDPA Compliance in the Healthcare Sector
  • How CMS Is Tackling ‘Coverage Purgatory’ for Medical Devices
  • RAPID Device Coverage: A Narrow Bridge Over Medicare’s Coverage Gap

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amlegals.com /1 month ago

Medical Devices and Privacy by Design: A Way to DPDPA Compliance in the Healthcare Sector

Introduction The healthcare sector in India is witnessing a change with the advancement of technology. The use of medical devices is not limited to wards and laboratories anymore....

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medcitynews.com /4 weeks ago

How CMS Is Tackling ‘Coverage Purgatory’ for Medical Devices

CMS unveiled new details of its new RAPID pathway, which is designed to close the gap between FDA approval and Medicare coverage for breakthrough medical devices. Industry reaction...

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thefdalawblog.com /3 weeks ago

RAPID Device Coverage: A Narrow Bridge Over Medicare’s Coverage Gap

By Jennifer D. Newberger & Adrienne R. Lenz, Principal Medical Device Regulation Expert —

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thehindubusinessline.com /4 weeks ago

‘Not an adjunct to the pharma industry’: Medical device representatives seek separate regulatory authority

In their letter to the Union Health Minister JP Nadda, they said, medical devices continue to be seen as “an adjunct to pharmaceuticals”, despite scientific, engineering and regula...

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thefdalawblog.com /3 weeks ago

FDA Turns the Spotlight on Regulatory Science: What Medical Device Developers Need to Know

By Jennifer D. Newberger —

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thehindubusinessline.com /2 weeks ago

Poor-quality medical devices being sold in India, stronger finished-product testing needed, says Pharma Secretary

Calls for stronger testing of finished devices and a regulatory framework designed specifically for the sector

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medcitynews.com /2 weeks ago

The Imperative of Distinguishing Medical-Grade Devices from Wellness Tech

Why the flood of consumer wellness devices demands clear boundaries between lifestyle improvement and clinical diagnostics The post The Imperative of Distinguishing Medical-Grade D...

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prweb.com /2 weeks ago

Laser Marking Technologies, LLC Announces FDA-Compliant UDI Marking Solutions for Medical Device Manufacturers Navigatin...

A new FDA inspection standard is making Unique Device Identification marking accuracy an actively enforced requirement, and Laser Marking Technologies, LLC offers cost-conscious la...

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thefdalawblog.com /4 weeks ago

Medical Device Regulatory Expert — Hyman, Phelps & McNamara, P.C. (Washington, D.C.)

Hyman, Phelps & McNamara, P.C., the nation’s premier law firm dedicated exclusively to FDA and healthcare regulatory law, is seeking an experienced Medical Device Regulatory Ex...

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thefdalawblog.com /1 month ago

A Sensor for Every Symptom: FDA Puts $1.1 Million Behind Digital Health in Drug Trials

By Mary Bass & Jennifer D. Newberger —

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natlawreview.com /1 month ago

From Code to Compliance: Decoding India’s Medical Device Software Guidance

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natlawreview.com /4 weeks ago

CMS, FDA Propose RAPID Pathway for Medicare Coverage of Certain Medical Devices

Key Takeaways The proposed RAPID pathway would create a new voluntary CMS/FDA process for certain innovative medical devices, with the stated goals of expediting Medicare coverage...

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medcitynews.com /6 days ago

This Device Could Prevent Lung Biopsy’s Most Common — and Costly — Complication

Selio Medical developed an FDA-cleared hydrogel device that seals CT-guided lung biopsy punctures before they can cause pneumothorax — a collapsed lung complication that affects up...

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histalk2.com /1 month ago

News 7/15/26

Top News Connected health devices company Withings launches Withings Medical ...

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uploadarticle.com /1 month ago

MDR Regulation: What Every Medical Device Company Needs to Know

The mdr regulation changes how medical devices are defined and classified throughout Europe. This transformation... The post MDR Regulation: What Every Medical Device Company Needs...

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hearingreview.com /1 month ago

FDA Formally Classifies Active Noise Attenuation Systems for Infant Incubators as Class II Devices

The regulatory action clears a pathway for future manufacturers to bring noise-canceling incubator systems to market through a less burdensome route.

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fiercebiotech.com /1 week ago

Medtronic recalls reflux monitoring device as 184 serious injuries linked to capsule

Medtronic is recalling certain esophageal pH monitoring capsule delivery devices amid risks of them failing whilst deployed.

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newswire.com /6 days ago

DistillerSR Joins European MedTech Consortium to Digitalize Medical Device and IVD Conformity Assessments

€4 million European-funded DIGICAP project brings together 19 organizations to replace document-based conformity assessments with machine-readable data. DistillerSR named one of fi...

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bioengineer.org /1 week ago

Virtual e-health system VIRTUES shows overwhelmingly positive results for monitoring cardiac devices

The End of the Waiting Room? Virtual Monitoring of Pacemakers and Defibrillators Proves as Safe as Clinic Visits — and Cheaper Every year, roughly 1.25 million people worldwide hav...

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textileworld.com /1 month ago

The Art and Science of Woven Biomedical Textiles: From Open Surgery to Micro-Implants

By Amir Islam For decades, the medical device industry has relied on textiles to solve some of the human body’s most complex mechanical challenges. From vascular grafts replacing d...

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qualitymag.com /1 month ago

Variscite and NRG Partner to Reduce Medical Device Development Risk

Variscite, a leading global System-on-Module (SoM) designer, developer, and manufacturer, and NRG, a medtech engineering partner for regulated software systems, announced a partner...

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orthotw.com /1 month ago

3D Systems Enables First FDA Clearance for Implant from a Point-of-Care Institution

- Collaboration with Defense Health Agency (DHA) enables Walter Reed 3D Medical Application Center (3D MAC) to achieve first FDA-cleared medical device - First-ever FDA clearance...

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supplychaingamechanger.com /1 month ago

How to Increase Transparency in the Medical Device Supply Chain!

Manufacturers of any medical device are the first ones to get the blame when a patient complains of suffering injury or harm from using a medical device. How does this relate to th...

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scmp.com /1 month ago

Chinese medical device makers push into Europe as anti-corruption squeeze bites at home

Facing anti-corruption policies and profit squeezing at home, Chinese innovative medical device companies are accelerating their push into the European market despite mounting cros...

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Sources covering Medical Devices

scmp.com

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amlegals.com

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bioengineer.org

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histalk2.com

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medcitynews.com

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natlawreview.com

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