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AtriCure Receives FDA Clearance to Expand its Labeling for Cryo Nerve Block Therapy
The expansion includes adolescent patients who can benefit from cryo nerve block therapy during surgical procedures involving the chest wall.Business Wire 01.20.21
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FDA Authorizes Interscope's EndoRotor System for Direct Endoscopic Necrosectomy
Product allows physicians to simultaneously resect, aspirate necrotic material from a walled-off pancreatic collection under direct endoscopic visualization.PR Newswire 01.19.21
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Telemedicine, Regulatory Changes to Characterize Medtech Industry in 2021
The global pandemic has created an urgent need for telemedicine.GlobalData 01.19.21
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SCONE Medical Awarded Emergency FDA Authorization for Self-Contained Negative Pressure Environment
Product evacuates contagious aerosols from the environment surrounding a patient during aerosol-generating procedures.Videos PR Newswire
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FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
New software version for Vantage Orian 1.5T also offers a solution to help clinicians image and quantify fatty liver disease.Business Wire 01.15.21
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FDA Clears Fever-Detecting Vital Data Sensor in New Cardiac Monitor
Product contains integrated sensor technologies designed to measure patient activity, heart rate, and body temperature.PR Newswire 01.14.21
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Digital Health | Software & IT
FDA Releases Artificial Intelligence, Machine Learning Action Plan
Outlines FDA’s next steps toward furthering oversight for AI/ML-based "software as a medical device."U.S. Food and Drug Administration 01.13.21
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Contract Manufacturing
Vonco Products Receives ISO 13485:2016 Certification
Both a packaging company and a components company, Vonco started as a custom equipment and packaging pioneer.Business Wire 01.12.21
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TransEnterix's Senhance Surgical System Approved in Russia
The Senhance System is designed to maintain laparoscopic minimally invasive surgery standards while providing digital benefits.Business Wire 01.12.21
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Anitoa Granted CE Mark for its Maverick Series Portable qPCR Instruments
The company has previously demonstrated Maverick technology in detecting several types of pathogen DNA and RNA strands.PR Newswire 01.11.21
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Exero Medical’s Smart Sensor Granted FDA Breakthrough Designation
The product provides data on internal tissue healing in the gastrointestinal tract.Exero Medical 01.11.21
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Diagnostics
SARS-CoV-2 Mutation Prompts FDA Alert
Impact remains low, but false negative results can occur with any molecular test.U.S. Food and Drug Administration 01.11.21
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Cardiovascular
Acutus Medical Launches AcQCross Transseptal System in Europe
The product is designed to improve safety and efficiency in any procedure requiring left heart access.Globe Newswire 01.08.21
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Mike on Medtech: CDRH 2021 Priorities
Mike Drues and Sean Fenske discuss several of the priorities the agency has been talking about recently and why they are important.Sean Fenske, Editor-in-Chief 01.08.21
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Caretaker Medical Receives Canadian Approval for Wireless Patient Monitor
The device measures continuous, uninterrupted blood pressure, heart rate, respiration rate, SpO2, and other vital signs.PR Newswire 01.04.21
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New Home Use Indication Granted for the Passio Pump Drainage System
Product is designed for the drainage of recurrent and symptomatic pleural effusion.PR Newswire 12.15.20
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Mike on Medtech: Communicating with the FDA
Mike Drues and Sean Fenske discuss methods of communicating with the agency and share best practices for doing so.Sean Fenske, Editor-in-Chief 12.15.20
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Preparing Your Design Controls for FDA Approval
Design controls are a set of procedures to build into medical device design and development.Online Exclusives Adam Freeman, Freelance Medical Device and Combination Product Design Specialist, Kolabtree 12.09.20
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Sofwave Medical Granted CE Mark for Skin Tightening, Wrinkle Reduction Device
Company's device also received regulatory approval from the Medical Device Division of the Israeli Ministry of Health.PR Newswire 12.09.20
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Survey Finds On-Site Inspections Plummeted by 93 Percent
Findings from Greenlight Guru survey reveal internal divides within organizations are making medical device companies less competitive.Greenlight Guru 12.08.20
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Shimmer Research Receives CE Certification for Inertial Measurement Unit Sensor
The wearable sensor is now recognized as a medical device in Europe, capable of providing continuous, medical-grade measurements of a person’s activity.Shimmer Research 12.07.20
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Diagnostics
FDA Clears AI-Powered Full Field Peripheral Blood Smear Application
Israel-based Scopio Labs' solution is tailored to augment hematology diagnostics.Scopio Labs 12.02.20
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CARMAT Obtains Approval to Resume PIVOTAL Study Implants in France
Thirteen total implants have been performed thus far within the PIVOTAL study framework.CARMAT 12.01.20
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First National Pediatric Cardiac Screening Database is Established
FDA, industry, and patient advocacy groups join effort to advance effective cardiac screening.Business Wire 11.30.20
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FDA Ruling Expands Patient Access to Video Capsule System
Patients now have access to a mechanism for evaluating the small intestine without in-person interactions with clinicians.PR Newswire 11.30.20
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Propel Launches Integrated QMS, PLM, and Regulatory Solution for Device Industry
The platform includes new capabilities related to electronic instructions for use and global product registration.Propel 11.24.20
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Reducing Exposure During Customer Audits
Two audit streamlining methods are highlighted to help suppliers reduce exposure from outside visitors associated with customer audits.Online Exclusives Nicolle Cannon, Founder/CEO, Cannon Quality Group 11.23.20
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Reflow Medical Receives Japanese Approval for the Wingman CTO Catheter
The Wingman Catheter crosses peripheral CTOs using an extendable beveled tip.Business Wire 11.18.20
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FDA Agrees to Participate in MDIC's Collaborative Community Initiative
Effort is designed to help advance medical device quality and safety to achieve better patient outcomes.Business Wire 11.17.20
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FDA Grants Breakthrough Device Designation for Magnetic Anastomosis Technology
The innovation is designed to help surgeons deliver less invasive solutions through magnetic compression anastomosis.GI Windows Medical Corp. 11.13.20
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Portable Dual-Energy X-Ray Receives Health Canada Approval
The X-ray detector simultaneously delivers DR, bone, and tissue images in one shot.Business Wire 11.09.20
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DuraSorb Monofilament Mesh Earns CE Mark Approval
Soft tissue support product soon available in Europe for abdominal wall, cosmetic, and reconstructive breast procedures.Business Wire 11.06.20
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HeartHero Inc. Awarded ISO 13485 Certification
Company to continue regulatory path for AED in collaboration with the American College of Cardiology.Business Wire 11.05.20
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Quality Assurance When Supply Chain Disruptions Arise
From supply chain disruptions to impromptu manufacturing modifications, the medical device industry has faced a whirlwind of complications in 2020.Sandi Schaible and Peter Steen, WuXi AppTec Medical Device Testing 11.04.20
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Congress Examines Additional COVID-19 Relief and Recent Regulatory Changes
The legislative year is nearly coming to a close as Washington survives yet another tumultuous election cycle.Jeffrey J. Kimbell, Eric P. Juhl, JD and David C. Rudloff, Jeffrey J. Kimbell & Associates Inc. 11.04.20
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keepMED Raises Funding for Regulatory Clearance of its Sleep Apnea Device
Company's technology mobilizes the user’s respiratory system to deliver just the amount of PAP needed, intermittently and with minimal airflow.Business Wire 11.04.20
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My 2020 Holiday Wish List
There are many lessons to be learned from actions taken during the pandemic. Are there positives that can actually be taken from this mess?Sean Fenske, Editor-in-Chief 11.04.20
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Ocutrx Vision Technologies Awarded Two Patents for Visual Field Testing, Dynamic Opacity Innovation
One of the patents covers the company’s visual field perimetry testing technology.Ocutrx Vision Technologies LLC 11.02.20
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FDA Grants Enforcement Discretion for Home Use of a Small Bowel Capsule Endoscope
The decision permits a fully remote capsule endoscopy procedure, eliminating the need for in-person interaction between clinic staff and patients.11.02.20
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Mike on Medtech: Biocompatibility and Nitinol Guidances
Mike Drues and Sean Fenske discuss two FDA guidance documents that focus on biocompatibility and nitinol-containing devices.Sean Fenske, Editor-in-Chief 10.26.20
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MDIC Report Outlines Best Practices for Enhancing Patient Communication About Medical Devices
The report summarizes key terms and provides evidence-based tools and resources to help develop an effective communication strategy.Business Wire 10.21.20
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Optikos Receives ISO 13485:2016 Certification
The company provides both optical engineering and volume manufacturing services.Business Wire 10.21.20
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FDA Clears Alydia Health’s Jada System
Product is designed to control bleeding for mothers with postpartum hemorrhage and abnormal postpartum uterine bleeding.Business Wire 10.20.20
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FDA Clears Minnetronix Medical's Neurosurgical Access Platform
Company expands on 25 years of experience with a new portfolio of neuro devices, including an expandable port for deep brain access.Business Wire 10.20.20
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FDA Clears Masimo O3 Regional Oximetry for Somatic Applications
Product is also authorized for the measurement of relative changes in cerebral hemoglobin.Business Wire 10.13.20
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ASTM International Signs MoU With New Zealand’s National Standards Body
Pact will support Standards NZ’s review and consideration of ASTM standards for reference or adoption as solutions for New Zealand’s industry concerns.ASTM International 10.09.20
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FDA Clears Jointechlabs' MiniTC for Point-of-Care Fat Tissue Processing
MiniTC allows for the processing of adipose (fat) tissue without exposure to the external environment.PR Newswire 10.09.20
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Myomo Extends, Strengthens its Global MyoPro Patent Portfolio
New multi-joint patents issued in both the United States and Europe.Business Wire 10.09.20
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MDIC Releases Real-World Evidence Framework for In Vitro Diagnostics
The framework focuses on considerations related to real-world evidence for IVDs.Business Wire 10.08.20
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Endospan Receives FDA IDE Approval for NEXUS Aortic Arch Stent Graft System Study
The trial will assess the NEXUS in some of the most challenging aortic arch pathologies that physicians encounter.Business Wire 10.07.20
