Successfully Incorporating Remote Audits Post-Pandemic—A Medtech Makers Q&A
The pandemic caused remote audits to become the norm for a period of time, but lessons learned could keep the practice in place.
Regulatory
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FDA Clears Truvic's Prodigy Thrombectomy System
The product is designed to treat peripheral vascular thrombus.Michael Barbella, Managing Editor 05.23.22
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Cardiovascular | Digital Health
FDA Clears Arterys' AI Mapping and Quantification Tools
Company also releases its next-generation Cardio AI application.Michael Barbella, Managing Editor 05.20.22
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FDA Clears Innovia Medical's Sterizone VP4 Sterilization Process
The low-temperature sterilization system can quickly process high volumes of heat and moisture-sensitive devices.Michael Barbella, Managing Editor 05.18.22
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New Patents Add Value to Know Labs' Bio-RFID Tech
Patents refer to deriving an analyte database from one or multiple subjects and from one or multiple non-invasive sensors.Michael Barbella, Managing Editor 05.17.22
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Ra Medical Granted Patent for Catheters With Expanded Ablation Area
Patent will make it easier for company to develop products that address larger diameter vessels.Michael Barbella, Managing Editor 05.17.22
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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
There have been 60 injuries and 23 deaths related to this issue.Sam Brusco, Associate Editor 05.16.22
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Japanese Regulators Approve Shockwave Medical's Coronary IVL
The Shockwave C² coronary IVL catheter received premarket approval (PMA) from the FDA last year.Michael Barbella, Managing Editor 05.16.22
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ENDRA Life Sciences Achieves ISO 13485 Recertification
The company is developing Thermo Acoustic Enhanced UltraSound, a technology for visualizing tissue like MRI.Michael Barbella, Managing Editor 05.13.22
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Optellum Gains CE Marking for Early Lung Cancer Detection Tech
Company's AI-powered clinical decision-support software tool helps clinicians identify and track at-risk patients who present suspicious lung nodules.Michael Barbella, Managing Editor 05.13.22
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Health Canada Approves NanoVibronix's PainGuard and UroGuard
Approval will help the company expand internationally.Michael Barbella, Managing Editor 05.12.22
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FDA Clears NeuroLogica's Photon-Counting CT Tech
Company's OmniTom Elite can provide versatile, real-time mobile imaging to administer point-of-care CT.Michael Barbella, Managing Editor 04.28.22
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Capillary Biomedical Earns ISO 13485:2016 Certification
Company recently received FDA IDE approval to begin a study of its seven-day wear infusion set technology.Michael Barbella, Managing Editor 04.25.22
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NESTcc Partners with Aetion to Advance the Use of Real-World Evidence
Aetion will support the development of NESTcc's Analytics Core offering, contributing to NESTcc's RWE initiatives.04.21.22
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C₂N Achieves ISO 13485:2016 Certification
Company's lab has earned Clinical Laboratory Improvement Amendments (CLIA) certification.Michael Barbella, Managing Editor 04.21.22
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Guard Medical Gains FDA Clearance for Additional NPseal Sizes
NPseal delivers the same negative pressure wound therapy as more expensive and complex NPWT devices.Michael Barbella, Managing Editor 04.19.22
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FDA Clears CARESTREAM's Smart Noise Cancellation Tech
The technology isolates noise to produce diagnostic images that are significantly clearer than with standard processing.Michael Barbella, Managing Editor 04.12.22
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FDA Clears Transit Scientific's XO Cross Support Catheter Platform
Support catheters help navigate guidewires through complex lesions and facilitate guidewire exchanges during interventional procedures.Michael Barbella, Managing Editor 04.12.22
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Breakthrough Device Designation Granted to Applaud Medical's Acoustic Enhancer
Product is used in conjunction with ureteroscopy with laser lithotripsy for fragmenting calcium-based kidney stones.Michael Barbella, Managing Editor 04.05.22
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FDA Approves Trial for Capillary Biomedical's SteadiFlow Tech
Company's new infusion sets are designed to significantly extend patient wear time to seven days and maintain insulin stability.Michael Barbella, Managing Editor 03.29.22
