MRI2CT Secures FDA Clearance for AI-Powered NextMR Spine Imaging Platform

Shots: The US FDA has granted 510(k) clearance to NextMR, an AI-powered platform that generatesaccurate 3D bone visualization of the lumbar spine & sacrum directly from standarddiagnostic MRI scans NextMR works on MRI sequences acquired on 1.5T & 3T scanners, and generates 3D bone morphology in under 60sec., potentially reducing the need for additional imaging…

ByRidhi RastogiOctober 7, 2026

NEWS

Click Therapeutics Receives 510(k) Clearance for Motivista to Treat Negative Schizophrenia Symptoms

Shots: FDA granted 510(k) clearance to Motivista (CT-155), a prescription digital therapeutic for treating negative symptoms of schizophrenia as an adjunct to clinician-managed outpatient care, incl. antipsychotic therapy, in pts (≥18yrs.) with clinically stable positive symptoms Clearance was supported by the P-III (CONVOKE) trial assessing CT-155 vs a digital control app in pts (≥18yrs.) with…

ByRidhi RastogiOctober 7, 2026

NEWS

QIAGEN Receives the US FDA Clearance for QIAstat-Dx BCID GN Plus AMR Panel

Shots: The US FDA has granted clearance to the QIAstat-Dx BCID GN Plus AMR Panel, completing QIAGEN’s US bloodstream infection testing portfolio with coverage of gram-negative bacteria & antimicrobial resistance markers The new panel can detect 13 gram-negative bacterial targets & 18 AMR markers from positive blood cultures in about one hour, complementing the previously…

ByRidhi RastogiSeptember 28, 2026

NEWS

NET Recovery Reports the US FDA Breakthrough Device Designation of NET Device for Stimulant Use Disorder

Shots: The US FDA has granted Breakthrough Device Designation for its NET Device as an aid in reducing psychostimulant use in adults diagnosed with stimulant use disorder, incl. cocaine use disorder & amphetamine-type/ methamphetamine use disorder NET Recovery is designing a pivotal randomized controlled trial intended to support FDA marketing authorization, which the company believes…

ByRidhi RastogiSeptember 24, 2026

NEWS

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 RastogiSeptember 22, 2026

NEWS

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

INSIGHTS+

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

NEWS

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

NEWS

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

NEWS

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

MRI2CT Secures FDA Clearance for AI-Powered NextMR Spine Imaging Platform

Click Therapeutics Receives 510(k) Clearance for Motivista to Treat Negative Schizophrenia Symptoms

QIAGEN Receives the US FDA Clearance for QIAstat-Dx BCID GN Plus AMR Panel

NET Recovery Reports the US FDA Breakthrough Device Designation of NET Device for Stimulant Use Disorder

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

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