Cordis’ Selution SLR Drug-Eluting Balloon Receives US FDA Approval for In-Stent Restenosis

Shots: The US FDA has approved the Selution SLR (Sustained Limus Release) Drug-Eluting Balloon (DEB) for the treatment of coronary in-stent restenosis (ISR) Approval was supported by data from the SELUTION4ISR trial assessing Selution SLR DEB vs SoC, incl. 80% drug-eluting stents, in pts (n >400) with coronary ISR across the US, Canada, Brazil, &…

ByRidhi Rastogi6 hours ago

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Aptitude Receives US FDA Clearance for Next-Generation Metrix COVID Test

Shots: The US FDA has granted 510(k) clearance to the next-generation Metrix COVID Test, with development supported by BARDA. The test is cleared for OTC and professional use in CLIA-waived settings The handheld molecular test delivers approximately 3-fold higher analytical sensitivity & 30% faster results than EUA-authorized product, targeting urgent care & other decentralized settings Aptitude…

ByRidhi RastogiSeptember 17, 2026

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EMA Marketing Authorization of New Drugs in August 2026

Shots: The European Commission (EC) approved Daybu (trofinetide) and Hopledo (modified-release levodopa/carbidopa) for neurological disorders, expanding treatment options for Rett syndrome and Parkinson’s disease, respectively. Daybu was approved for neurobehavioral symptoms of Rett syndrome in patients aged ≥5 years, while Hopledo was approved for adults with Parkinson’s disease and moderate to severe motor fluctuations. The…

ByRidhi RastogiSeptember 15, 2026

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Cebreo Medical Reports CE Mark Approval of NeuroBuds for Ambulatory EEG Monitoring

Shots: Cebreo Medical has reported the CE Mark approval of its NeuroBuds device to be used unassisted by the patient at home for extended, ambulatory electroencephalogram (EEG) monitoring NeuroBuds, designed to resemble a hearing aid, minimizes the stigma & burden of long-term EEG monitoring, enabling comfortable, unassisted use for ~3mos. with repeat measurements Cebreo Medical…

ByRidhi RastogiSeptember 15, 2026

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Nutromics Receives FDA Breakthrough Device Designation for Vancomycin TDM Patch

Shots: The US FDA has granted Breakthrough Device Designation to a wearable Vancomycin therapeutic drug monitoring (TDM) Patch, designed to continuously monitor vancomycin levels & support faster, more personalized dosing decisions In Feb 2026, Nutromics published first-in-human data on its molecular monitoring platform in Nature Biotechnology, plus the company has conducted ICU clinical studies in…

ByRidhi RastogiSeptember 11, 2026

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Johnson & Johnson Secures CE Mark Approval for ACUVUE OASYS MAX Reusable Contact Lenses

Shots: J&J has received CE Mark approval for Acuvue Oasys MAX 2-Week, a reusable contact lens featuring MAX technologies designed for superior comfort & visual clarity through day 14 Key features incl. OptiBlue Light Filter, which filters ≥60% blue-violet light, TearStable Tech that locks in moisture, & Class 1 UV blocking, when combined help to…

ByRidhi RastogiSeptember 11, 2026

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Emboline Receives US FDA 510(k) Clearance for Emboliner Embolic Protection System

Shots: FDA has granted 510(k) clearance to Emboliner Embolic Protection System for use as an embolic protection device to capture & remove embolic material during transcatheter aortic valve replacement (TAVR), with phased commercial launch to begin later this year Clearance was backed by extensive clinical data, incl. the PROTECT H2H IDE study assessing Emboliner vs. Sentinel Cerebral…

ByRidhi RastogiSeptember 10, 2026

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Abbott’s TactiFlex Duo Ablation Catheter Secures FDA Approval for Atrial Fibrillation

Shots: The US FDA has approved TactiFlex Duo Ablation Catheter, Sensor Enabled to treat patients with challenging cases of atrial fibrillation (AFib) Approval was based on the results from Abbott's FlexPulse IDE study, with data recently presented at the ESC’26 & simultaneously published in EPEuropace, showing favorable safety & effectiveness outcomes in pts with paroxysmal AFib TactiFlex Duo delivers…

ByRidhi RastogiSeptember 9, 2026

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United Imaging Healthcare Receives CE Mark for Dual Wide-Coverage CT Systems

Shots: United Imaging Healthcare has received CE Mark certification for uCT SiriuX and uCT SiriuX Ultrix, described as the world’s first dual wide-coverage CT family, enabling commercial availability across the EU Built on a Twin-Ring Gantry architecture, the systems combine dual-wide 16cm Ultrix detectors with 2 liquid-metal-bearing X-ray tubes to support synchronized whole-organ dynamic imaging,…

ByRidhi RastogiSeptember 4, 2026

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Vara Gains CE Certification for Autonomous Breast Cancer Screening AI

Shots: Vara has secured CE certification under the EU Medical Device Regulation (Class IIb) for autonomous triage in organised breast cancer screening, enabling normal examinations to be reported without radiologist review ATMON (Autonomous-Triage Monitoring) is a real-time system that monitors AI performance, mammography hardware, system health, & site-level signals. If predefined limits are exceeded, the…

ByRidhi RastogiSeptember 2, 2026

Cordis’ Selution SLR Drug-Eluting Balloon Receives US FDA Approval for In-Stent Restenosis

Aptitude Receives US FDA Clearance for Next-Generation Metrix COVID Test

EMA Marketing Authorization of New Drugs in August 2026

Cebreo Medical Reports CE Mark Approval of NeuroBuds for Ambulatory EEG Monitoring

Nutromics Receives FDA Breakthrough Device Designation for Vancomycin TDM Patch

Johnson & Johnson Secures CE Mark Approval for ACUVUE OASYS MAX Reusable Contact Lenses

Emboline Receives US FDA 510(k) Clearance for Emboliner Embolic Protection System

Abbott’s TactiFlex Duo Ablation Catheter Secures FDA Approval for Atrial Fibrillation

United Imaging Healthcare Receives CE Mark for Dual Wide-Coverage CT Systems

Vara Gains CE Certification for Autonomous Breast Cancer Screening AI

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