Regulatory
-
FDA Clears Insignis Subcutaneous Needle Sets
Innovative Health Sciences' 26-gauge subcutaneous needle sets are offered in single, bifurcated, trifurcated, and quad-furcated sets.Innovative Health Sciences LLC 11.30.21
-
Bridging the Gap Between ERs and GSPRS
How to make the transition from MDD to MDR go as smoothly as possible.Online Exclusives Smridula Hariharan, Freyr Solutions 11.29.21
-
FDA Clears Negative Pressure Surgical Incision Management System
Aatru Medical's NPSIMS uses a mode-of-action that eliminates the expensive electromechanical pump, battery, and electronics found in other systems.Aatru Medical 11.29.21
-
Required Signoffs Before Proceeding—Quality Giggles
A moment of diversion to help you ease back into the week with a light-hearted chuckle at quality concerns.MasterControl 11.29.21
-
PinMed Adds Two Patents to its Portfolio
Two of the solutions were developed for the National Institutes of Health (NIH) Clinical Center.PR Newswire 11.23.21
-
Training Controls on...Pets?—Quality Giggles
A moment of diversion to help you ease back into the week with a light-hearted chuckle at quality concerns.MasterControl 11.22.21
-
MediSure Canada Receives Medical Device Establishment License
License enables company to source Class II through Class IV diagnostic and therapeutic medical devices worldwide.Accesswire 11.19.21
-
Aligning Regulatory and Commercial Strategies—Mike on Medtech
Mike Drues and Sean Fenske discuss how a company can optimize its commercial strategy through a smart regulatory strategy.Sean Fenske, Editor-in-Chief 11.16.21
-
Update on Recall of Philips Breathing Assistance Machines
Update on earlier announced voluntary CPAP, BiPAP, and Mechanical Ventilator recall notification.U.S. Food and Drug Administration 11.15.21
-
President Biden to Nominate Dr. Robert Califf for Commissioner of Food and Drugs
Califf brings nearly four decades of experience as a doctor, researcher, leader & public servant, including previous service as FDA commissioner.The White House 11.15.21
-
Recent ISO Standards Highlight Global Submission Complexities
Despite their challenges, global submissions may be ideal for manufacturers on several fronts.Sandi Schaible, Dr. Sherry Parker, and Mark Cabonce, WuXi AppTec 11.10.21
-
MDR/IVDR Rollout and Challenges—2021 Year in Review
With the MDR sprint mercifully behind them, medtech firms must now turn their attention to the next leg of Europe’s revamped regulatory relay: the IVDR.Michael Barbella , Managing Editor 11.10.21
-
Cardiovascular
FDA Premarket Approval Granted for Wearable Cardioverter Defibrillator
Kestra Medical's ASSURE WCD can analyze a patient’s heart rhythm and independently identify a dangerous arrhythmia.Business Wire 11.04.21
-
Digital Health | Software & IT
FDA Issues Guidance on Premarket Submissions for Device Software Functions
Hopes to provide clarity, simplicity, and harmonization with current best practices.U.S. Food and Drug Administration 11.04.21
-
Joseph Azary Launches Aztech Regulatory & Quality LLC
A consulting firm that specializes in quality and regulatory compliance for the medical device industry.Aztech Regulatory & Quality LLC. 11.01.21
-
NanoVibronix Receives Australian Approval for UroShield
Company signs agreement with DukeHill Healthcare to distribute UroShield and PainShield in the country.Business Wire 10.29.21
-
NAMSA Receives ASCA Accreditation for Device Biocompatibility Testing
The ASCA Pilot Program clears the first hurdle in the medical device premarket regulatory process.Business Wire 10.28.21
-
Surgical
FDA Strengthens Breast Implant Safety Requirements, Updates Study Results
Agency adds restrictions and approves new labeling for all approved breast implants.U.S. Food and Drug Administration 10.27.21
-
FDA Approves Implantable Brain Computer Interface Trial
Study paves the way for Synchron’s Stentrode to become the first commercially available implantable brain computer interface.Business Wire 10.27.21
-
It’s Time to Harmonize Quality and Regulatory with Industry 4.0 Technology
How to ensure quality at scale while also mitigating potential regulatory compliance issues and improving costs, efficiency, & customer satisfaction.Online Exclusives Kari Miller, Director, QMS Regulatory and Product Management, IQVIA 10.26.21
