Regulatory
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MICRO's Costa Rica Facility Achieves ISO 13485:2016 Certification
Opened late in 2021, the building includes a new clean room assembly facility within the manufacturing center.Michael Barbella, Managing Editor 02.01.23
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Cardiovascular
Medtronic's Recall of Mahurkar Catheters is Class I
A catheter hub defect may cause leaks across the catheter's tubes.Sam Brusco, Associate Editor 01.30.23
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Cardiovascular
Getinge's Recall of Cardiosave Hybrid and Rescue IABPs is Class I
Burst, leaking, or torn balloons can cause blood to enter the IABP during therapy.Sam Brusco, Associate Editor 01.27.23
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ISO Certifications Granted to Aural Analytics for Clinical-Grade Speech Analysis Tech
The company's Speech Vitals technology is being used in 30 concurrent clinical studies.Michael Barbella, Managing Editor 01.23.23
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Japanese Regulators Approve Motiva Implants, Tissue Expander
The products have also received reimbursement for post-mastectomy reconstruction under the Japanese National Health System.Michael Barbella, Managing Editor 01.20.23
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New FDA Clearance Granted to RapidAI's Intracranial Hemorrhage Triage Tool
New version of ICH reduces notification fatigue with a near perfect false positive rejection rate.Michael Barbella, Managing Editor 01.19.23
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CE Mark Awarded to KA Imaging's Reveal 35C X-Ray Detector
Product features SpectralDR technology for dual-energy subtraction, providing bone and tissue differentiation with a single standard X-ray exposure.Michael Barbella, Managing Editor 01.18.23
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Breakthrough Device Designations Granted for AVITA Medical's RECELL System
The RECELL System was approved by the FDA in September 2018.Michael Barbella, Managing Editor 01.13.23
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Olympus Issued 2 FDA Warning Letters
Concerns violations in reporting and quality system regulations for endoscopes and accessories.Sam Brusco, Associate Editor 01.12.23
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Cerus Wins Canadian Approval for Extended Platelet Storage With INTERCEPT System
Regulatory decision enables Canadian Blood Services to plan a broader implementation across its market.Michael Barbella, Managing Editor 01.04.23
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Health Canada Approves Sonendo's Next-Gen GentleWave G4 System
Product is designed for an elevated user experience, improved workflow, and optimized practice efficiency.Michael Barbella, Managing Editor 01.04.23
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FDA Clears Intelligent Ultrasound's ScanNav Peripheral Nerve Block Device
With the addition of a new femoral block, ScanNav Anatomy PNB now supports anatomy highlighting for 10 vital regions.Michael Barbella, Managing Editor 12.16.22
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FDA Clears New Laboratory Blood Glucose Reference Analyzer
Nova Primary uses a single, reusable glucose electrochemical sensor based on glucose oxidase and has a measurement range of 20-900 mg/dL.Michael Barbella, Managing Editor 12.16.22
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Brazil's ANVISA Approves Allurion Gastric Balloon
Company estimates total market opportunity of roughly 1.3 million eligible consumers.Michael Barbella, Managing Editor 12.15.22
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FDA Clears Radiation Shield System From Radiaction Medical
Latest authorization permits the Radiaction Shield System to be used in more U.S. labs.Michael Barbella, Managing Editor 12.14.22
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Cardiovascular
CARMAT to Resume Artificial Heart Clinical Study in France
Four centres have undergone refresher trainings on the product ahead of the restart.Michael Barbella, Managing Editor 12.09.22
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How to Achieve MDR Compliance
The new Medical Device Regulation applies to all manufacturers who intend to sell medical devices in the European Economic Area.Online Exclusives Martina Pieper, Senior Marketing Manager at Dunlee 12.08.22
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Cardiovascular
FDA Grants Breakthrough Designation to CorVista System
The product is designed to indicate the likelihood of elevated mean pulmonary arterial pressure at the point-of-care.Michael Barbella, Managing Editor 12.08.22
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SINBON Electronics Achieves MedAccred Accreditation
Company now plans to implement MedAccred at several other global sites.Michael Barbella, Managing Editor 12.06.22
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FDA Clears FUJIFILM Healthcare's Endoscopic Ultrasound Scope
Company enables endoscopic ultrasound scope compatibility for its ARIETTA 850 ultrasound processor with its newly 510k cleared EG-740UT scope.Michael Barbella, Managing Editor 12.01.22
