Regulatory
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FDA Clears MeMed BV Direct From Whole Blood
Allows clinicians to more rapidly distinguish bacterial from viral infections.Michael Barbella, Managing Editor 09.22.23
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Digital Health
Vitalchat Awarded Patent for Patient Monitoring, Bandwidth Conservation Tech
The video analytics feature uses edge computing to monitor patients and hospital spaces for movement and voice cues, transferring metadata 24/7.Michael Barbella, Managing Editor 09.21.23
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South Korean Regulators Authorize Expanded NeuroStar TMS Indications
Approval is the first international consent for expanded indication and certification for MT Cap and D-Tect technologies.Michael Barbella, Managing Editor 09.21.23
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FDA Approves IDE Use of ExThera Medical's OncoBind Extracorporeal Procedure
The blood filtration procedure removes circulating tumor cells in pancreatic cancer patients.Michael Barbella, Managing Editor 09.19.23
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FDA Approves Urotronic's BPH Catheter System
The company won FDA approval for Optilume after running a clinical trial that compared the device to a sham treatment in 148 patients.Michael Barbella, Managing Editor 09.18.23
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FDA Approves IDE Trial of Verve Medical's Treatment for Uncontrolled Hypertension
Company's Renal Pelvic Denervation System showed a 20.3 mm Hg reduction in blood pressure and a 12-month durability.Michael Barbella, Managing Editor 09.14.23
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Pearl's Second Opinion AI Platform Granted EU-MDR Certification
Flagship solution is the first and only AI-based dental pathology detection software to be certified as a Class IIa medical device under EU-MDR.Michael Barbella, Managing Editor 08.23.23
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Canadian Regulators Approve FemCath Intrauterine Catheter
Product is the first intrauterine catheter that allows clinicians to selectively evaluate a fallopian tube with natural saline and air contrast.Michael Barbella, Managing Editor 08.17.23
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Cardiovascular
FDA Clears Tractus Vascular's Tunnel Crossing Catheter
The company's Jigsaw Technology shaft offers high buckle resistance, yielding superior pushability across difficult occlusions.Michael Barbella, Managing Editor 08.17.23
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Cardiovascular
FDA Clears Sparrow’s Smartphone Stethoscope
Breakthrough SaaMD enables smartphones to be used as stethoscopes that capture, analyze, and share cardiovascular and pulmonary sound data.Michael Barbella, Managing Editor 08.14.23
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Cardiovascular
Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps
The company recalled the IABPs over unexpected shutdown due to electrical failures in their power management or solenoid boards.Sam Brusco, Associate Editor 08.10.23
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CE Mark Approval Granted to Establishment Labs' MI Surgical Tools
The Motiva Channel Dissector, Balloon, and Injector are designed to be used in next-generation minimally invasive aesthetic procedures.Michael Barbella, Managing Editor 08.07.23
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Cardiovascular
FDA Grants Breakthrough Device Designation to Pulse Medical's μFR System
The angio-based physiological assessment tool has no pressure wire or hyperemic agents.Michael Barbella, Managing Editor 08.07.23
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Health Canada Approval Granted for COVID-19 Treatment With Near Infrared Light
Device is intended for COVID-19 patients who experience acute symptoms within seven days of symptom onset.Michael Barbella, Managing Editor 08.03.23
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Montrose Environmental, Thermo Fisher Partner on EtO Solution
Recent EPA regulations aim to reduce ethylene oxide emissions from chemical plants and commercial sterilizers.Michael Barbella, Managing Editor 07.25.23
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FDA Grants Expanded Pediatric Indication for Orchid Safety Release Valve
Linear Health's device is intended to reduce the risk of IV catheter failure and replacement in hospitals.Michael Barbella, Managing Editor 07.19.23
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Digital Health
Wellthy Therapeutics Secures FDA, HIPAA Certification for SaMD Platform
The platform is already compliant with EU MDR Class 1, ISO 13485, ISO 27001, ISO 27701, IEC 62304, and GDPR.Michael Barbella, Managing Editor 07.17.23
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Neuronetics Granted MDSAP, CE Mark Certification Under New MDR
MDSAP certification covers distribution in five countries, including the U.S., Japan, Canada, Australia, and Brazil.Michael Barbella, Managing Editor 07.11.23
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FDA Clears Hygh-Tec Catheter System for ICU Stool Drainage
Advanced Medical Balloon’s microscopically thin polyurethane balloon catheter systems address indications in intensive care.Michael Barbella, Managing Editor 07.06.23
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Canadian Regulators Approve FemCerv Endocervical Tissue Sampler
Femasys' product is the first endocervical tissue sampler designed to collect and contain a comprehensive sample to maximize quality and quantity.Michael Barbella, Managing Editor 07.03.23
