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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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FDA Approves Daytime Treatment for Sleep Apnea and Snoring
Signifier Medical’s proprietary therapy eXciteOSA is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology approved in the U.S.Michael Barbella, Managing Editor 02.23.21
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Navient Receives Chinese Regulatory Clearance for ENT Applications
The surgical navigation system is already approved in the United States, Europe, Canada, South Korea, Brazil, and Taiwan.Michael Barbella, Managing Editor 02.22.21
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FDA Clears B-Secur's HeartKey EKG/ECG Technology
The product's algorithms can be quickly integrated in semiconductors for devices in the medtech, health monitoring, and wellness sectors.Michael Barbella, Managing Editor 02.19.21
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FDA Appoints its First Cybersecurity Director
University of Michigan associate professor to serve a one-year term within the Center for Devices and Radiological Health.Michael Barbella, Managing Editor 02.17.21
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FDA Clears Pulse Biosciences' CellFX System
The product delivers Nano-Pulse Stimulation technology in dermatologic procedures.Michael Barbella, Managing Editor 02.17.21
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FDA Clears Rapid Acoustic Pulse Technology for Use in Cellulite
The RAP device induces mechanical disruption in fibrous structures, such as the septae contributing to dimples in cellulite.Michael Barbella, Managing Editor 02.10.21
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Cardiovascular
FDA Clears Wearable Electrocardiogram Sensor
The product offers extended ambulatory ECG recording up to three weeks.Michael Barbella, Managing Editor 02.08.21
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Tips for Reigniting Your MDR/IVDR Preparation
To get the MDR/IVDR preparation ball rolling again, here are four processes to help refocus on achieving compliance with the updated regulations.Nicolle Cannon, Founder and CEO, Cannon Quality Group LLC 02.03.21
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How to Better Prepare for Regulatory Requests and Minimize Impact
Pressure to increase efficiency in medical device development has been prevalent over the past year, especially with the intensified regulatory expectations.Sandi Schaible, Sherry Parker and Kim Ehman, WuXi AppTec Medical Device Testing 02.03.21
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Pulse Biosciences Granted CE Mark Approval for CellFX System
Product delivers nano-pulse stimulation technology to clear hard-to-treat benign skin lesions.Michael Barbella, Managing Editor 02.03.21
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Stericycle Settles Environmental Violations at Its Medical Waste Incinerator
Agreement includes Supplemental Environmental Project to provide low-emitting school buses to local school district.Michael Barbella, Managing Editor 02.01.21
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FDA Clears 3D Acellular Dermal Matrix
The technology is supported by more than 150 peer-reviewed published articles.Michael Barbella, Managing Editor 01.27.21
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FDA Clears a Portable Hemodialysis System
Quanta Dialysis Technologies' SC+ system became available in the U.K. last year.Michael Barbella, Managing Editor 01.26.21
