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  Aptar CSP Technologies Earns ISO 13485 Certification

  Recognition comes as the company prepares to commercialize a new medical device using its proprietary 3-Phase Activ-Polymer platform technology.

  Aptar CSP Technologies 06.14.21
  

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  CE Mark Granted for Contego Medical's Next-Gen Carotid Stent

  Clinical trial results show a 100 percent success rate for the product.

  PR Newswire 06.10.21
  

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  Top 483s of 2020—Mike on Medtech

  Mike Drues and Sean Fenske discuss the issues medical device manufacturers had during inspections last year.

  Sean Fenske, Editor-in-Chief 06.08.21
  

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  Intertek Granted ASCA Recognition by FDA for Medical Device Premarket Testing

  he ASCA Pilot Program is a voluntary program developed to provide increased confidence in testing results.

  Michael Barbella, Managing Editor 06.04.21
  

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• Packaging & Sterilization
  

  Packaging Design Considerations to Ensure a Safe, Sterile Medical Device

  Choosing the right packaging configuration for a medical device is critical to ensure safety and sterility to the end user.

  Britt Jones, Manager, Chemistry & Package Testing, WuXi AppTec Medical Device Testing 06.02.21
  

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  FDA Clears Masimo's Radius PCG for the Root Patient Monitoring Platform

  Radius PCG with Bluetooth connectivity seamlessly integrates tetherless mainstream capnography with Root.

  Michael Barbella, Managing Editor 06.02.21
  

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• Digital Health
  

  FDA OKs First AI-Enabled Device for Colon Cancer Detection

  Product is composed of hardware and software designed to highlight portions of the colon where the device detects a potential lesion.

  Michael Barbella, Managing Editor 06.01.21
  

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  Chemence Medical Receives FDA Approval for Exofin Fusion Redesign

  Product line now features mesh that has curved ends.

  Michael Barbella, Managing Editor 05.25.21
  

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• 

  FDA Grants Marketing Clearance to Helius Medical's PoNS Device

  First tongue-delivered neuromodulation therapy provides new treatment option for patients living with gait deficit due to multiple sclerosis symptoms.

  Michael Barbella, Managing Editor 05.24.21
  

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  MedStar Health Joins NESTcc Research Network

  Partnership with largest health provider in U.S. capital region expands NESTcc research expertise, data capabilities for medical device evaluation.

  Michael Barbella, Managing Editor 05.21.21
  

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  nanoComposix Achieves ISO13485:2016 Certification

  Company recently expanded its manufacturing capability for large-scale production of 40 nm gold nanoparticles.

  Michael Barbella, Managing Editor 05.20.21
  

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  CE Mark Granted for Acutus Medical's EP Product Suite

  Greenlighted technologies are designed to streamline procedural workflow in all left heart procedures.

  Michael Barbella, Managing Editor 05.19.21
  

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  FDA Clears Nanox's Single-Source Digital X-Ray

  Company's technology digitally generates electrons and successfully replaces the thermionic filament ‎in the X-ray tube.

  Michael Barbella, Managing Editor 05.17.21
  

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  FDA Grants Breakthrough Device Status to Epilepsy Treatment System

  NeuroPace's RNS System is currently available in the United States as an adjunctive therapy for adults with drug-resistant focal epilepsy.

  Michael Barbella, Managing Editor 05.12.21
  

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• 

  Alvalux Medical Awarded Patent for Wearable Dermal Repair System

  Product helps improve old and prevent new hypertrophic and keloid scar healing.

  Michael Barbella, Managing Editor 05.11.21
  

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• 

  Conducting Remote GxP Audits: Three Keys to Success

  While remote audits have always been an option, the pandemic forced quality units to take a fresh look at how to use them effectively.

  Online Exclusives Paula Pilecki, Sr. Director of Project and Audit Management, MWA Consulting Inc. 05.07.21
  

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  FDA Approves Helius Medical's Stimulator Device for Gait Improvement

  The product is a short-term treatment for gait deficit as a result of mild to moderate symptoms from multiple sclerosis.

  Michael Barbella, Managing Editor 05.06.21
  

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  Embedding Risk-Based Thinking into Quality Efforts

  Controlling risk is an important requirement for companies developing regulated products.

  Online Exclusives David Jensen, Staff Writer, Master Control 05.04.21
  

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• Surgical
  

  FDA Clears XPERIENCE No Rinse Antimicrobial Solution

  The solution defends against germs for hours and can used in virtually every open surgery case.

  Michael Barbella, Managing Editor 05.04.21
  

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• 

  Breakthrough Device Designation Granted to Tempus’ Afib ECG Analysis Platform

  The platform was developed in collaboration with Geisinger.

  Michael Barbella, Managing Editor 05.03.21
  

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  Video & Analytics: Differentiators in a Compliance-Adherent Crowd

  Instead of checking the box with minimal investment in compliance, the firm that elevates its manufacturing practices beyond cGMP will gain more market share.

  Prasad Akella, Founder/CEO, Drishti 05.03.21
  

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  Ensuring Regulatory Compliance for Medical Device Manufacturing

  EMS providers have highly experienced quality teams that intimately understand the regulatory landscape for developing safe and effective medical devices.

  Tim McGinnis, Vice President, Medical Quality and Regulatory Affairs, Sanmina 05.03.21
  

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• 

  Japanese Approval Granted for Shape Memory's IMPEDE-FX Embolization Plug

  The product is indicated for use in Japan as an adjunct to devices such as stents, coils, and plugs.

  Michael Barbella, Managing Editor 04.30.21
  

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• 

  Preparing for the EU’s MDR

  As the clock to the deadline is in the final minutes, this article offers a few tips to help ensure companies meet with the requirements.

  Online Exclusives Nick Tippmann, Vice President of Marketing, Greenlight Guru 04.29.21
  

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• 

  Reprocessing of Single-Use Devices—Mike on Medtech

  Mike Drues and Sean Fenske discuss the European Commission’s guidelines for reprocessing single-use devices and the concerns with them.

  Sean Fenske, Editor-in-Chief 04.27.21
  

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  FDA Breakthrough Device Designation Granted for pdSTIM System

  Product from Stimdia Medical is designed to facilitate weaning patients from mechanical ventilation.

  Michael Barbella, Managing Editor 04.21.21
  

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  Acutus Medical Receives FDA Clearance of AcQCross

  Product family targets more than 300,000 annual U.S. electrophysiology and structural heart procedures.

  Michael Barbella, Managing Editor 04.15.21
  

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  Nagarro Achieves ISO 13485 Certification

  Company's iife sciences and healthcare business unit offers new opportunities in digital disruption and connected medical devices.

  Michael Barbella, Managing Editor 04.14.21
  

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  Berlin Heals' C-MIC Heart Failure Implant Achieves Breakthrough Device Status

  Company initiates an early feasibility study in the United States.

  Michael Barbella, Managing Editor 04.07.21
  

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• Testing
  

  The Evolution of Chemical Characterization for Medical Devices

  Evaluation of biological safety of devices is experiencing some of the most significant changes in history.

  Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec Medical Device Testing 04.01.21
  

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• Contract Manufacturing | Software & IT | Testing
  

  Quality & Regulatory Solutions for the FDA Regulated Industries

  EMMA International specializes in full-circle solutions for the medical device, biologics, and pharma industries.

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  Mike on Medtech: BDP Reimbursement Delay

  Mike Drues and Sean Fenske discuss the causes for the delay in rolling out the four-year reimbursement policy for breakthrough devices.

  Sean Fenske, Editor-in-Chief 03.30.21
  

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• 

  Neurolief's Brain Neuromodulation Technology Cleared by FDA for Migraine Treatment

  Relivion is the only non-invasive multi-channel neuromodulation technology for the treatment of acute migraine.

  Michael Barbella, Managing Editor 03.25.21
  

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• 

  Masimo's Rad-G With Temperature Earns CE Mark

  Rad-G can be converted from a handheld spot-check device into a continuous monitoring device, in the absence of other multi-parameter monitors.

  Michael Barbella, Managing Editor 03.24.21
  

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  FDA Breakthrough Device Designation Granted to Machine Learning Diagnostic Method

  Algorithm developed for earlier detection of gastrointestinal bleeding.

  Michael Barbella, Managing Editor 03.18.21
  

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  FDA Clears Rhythmlink's New MR Conditional Electrode Portfolio

  Sticky Pad Electrode line now boasts MR conditional clearance and CT compatibility.

  Michael Barbella, Managing Editor 03.15.21
  

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  Four Ways Remote Freelance Experts Can Help Medtech

  Changes in the regulatory landscape and working-from-home scenarios reduce the degree of change when working with remote consultants.

  Online Exclusives Ramya Sriram, Digital Content Manager, Kolabtree 03.15.21
  

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• 

  FDA Approves Pivotal Trial for Chronic Bronchitis Evaluation Tool

  The trial will assess the safety and efficacy of the RheOx System when used to treat chronic bronchitis symptoms.

  Michael Barbella, Managing Editor 03.15.21
  

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  CE Mark Granted to ProciseDx for Fecal Calprotectin Point-of-Care Testing

  Product will enable GI facilities in Europe to improve and accelerate patient care.

  Michael Barbella, Managing Editor 03.12.21
  

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  An Overview of the ASCA Pilot Program

  The FDA published a three-part final guidance on the voluntary program.

  Online Exclusives David Jensen, Staff Writer, MasterControl 03.11.21
  

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• Diagnostics
  

  EUA Granted for New COVID-19, Flu A, Flu B Combo Kit

  One multiplex real-time PCR diagnostic kit can simultaneously detect and differentiate SARS-CoV-2, influenza A and influenza B.

  Michael Barbella, Managing Editor 03.05.21
  

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  FDA Making Progress With Technology and Data Action Plans

  There is an urgent need to get advanced technologies into the healthcare ecosystem, but all products must first get regulatory approval.

  Alan Rencher, Vice President, Engineering, MasterControl 03.04.21
  

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  FDA Clears HydroMID Midline Catheter From Access Vascular

  Patented biomaterial used in catheter designed to reduce thrombus accumulation.

  Michael Barbella, Managing Editor 03.03.21
  

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  FDA Breakthrough Device Designation Awarded to BrainCool AB's Cooral System

  The Cooral System was CE marked in June 2020 as an invasive medical device.

  Michael Barbella, Managing Editor 03.02.21
  

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  Medtech Matters: FDA’s Ambiguity on Hyaluronic Acid

  MPO's Sean Fenske speaks with Mike Daley of OrthogenRx about the role HA plays in alleviating knee pain and the challenges with the FDA over it.

  Sean Fenske, Editor-in-Chief 03.02.21
  

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• Cardiovascular
  

  Soundbite Medical Wins Health Canada Approval for PAD Treatment

  Product targets patients with heavily calcified chronic total occlusions.

  Michael Barbella, Managing Editor 03.02.21
  

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  Mike on Medtech: Update on FDA's STeP Designation

  Mike Drues and Sean Fenske discuss the final guidance for the FDA’s STeP designation and who should use it.

  Sean Fenske, Editor-in-Chief 02.26.21
  

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• 

  FDA Clears Ava Fertility Tracking Wearable Device

  The wearable is clinically proven as effective as LH tests in predicting ovulation—and with more fertile days detected.

  Michael Barbella, Managing Editor 02.26.21
  

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• 

  First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System

  The product received CE Mark approval in January.

  Michael Barbella, Managing Editor 02.26.21
  

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• Cardiovascular
  

  FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

  Puzzle Medical Device's ModulHeart helps patients avoid open-heart surgery and reduces blood trauma.

  Michael Barbella, Managing Editor 02.25.21
  

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