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FDA clearance

PharmaDeviceNews FDA clearance
SurGenTec ION-L enters lumbar spine market as surgeons weigh minimally invasive fusion promise
Medical Devices & Diagnostics

Can SurGenTec’s ION-L system change how lumbar facet fixation fits into spine surgery?

Find out how SurGenTec’s ION-L FDA clearance could reshape minimally invasive lumbar facet fixation and spine surgery adoption.

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FDA clearance for Rubina Lens gives KARL STORZ a sharper open surgery proposition
Medical Devices & Diagnostics

Could KARL STORZ’s Rubina Lens turn open surgery into the next imaging battleground?

Find out how KARL STORZ’s Rubina Lens FDA clearance could expand fluorescence imaging in open surgery and hospital workflows.

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Representative image of an advanced neurovascular stroke procedure, illustrating how Rapid Medical’s TIGERTRIEVER 13 DISTALS trial data could support wider interest in small-vessel thrombectomy for distal and medium vessel occlusion stroke.
Medical Devices & Diagnostics

Why Rapid Medical’s DISTALS data could reshape treatment expectations in smaller stroke vessels

Distal stroke has long lacked device options. Rapid Medical’s TIGERTRIEVER 13 data now tests whether small-vessel thrombectomy can scale.

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Representative image: AI-powered digital pathology analysis could help reshape breast cancer risk stratification after ArteraAI Breast became the first FDA-cleared pathology-based breast cancer risk tool in the United States.
Medical Devices & Diagnostics

Can ArteraAI Breast turn routine pathology slides into breast cancer risk intelligence?

AI can read pathology slides, but can it change breast cancer treatment decisions? ArteraAI Breast puts that question before clinicians and payers.

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Representative image: A clinician uses a portable ultrasound and elastography system for non-invasive liver and spleen assessment, highlighting how E-Scopics’ FDA-cleared Hepatoscope enhancements could support point-of-care liver disease diagnostics and cirrhosis complication monitoring.
Medical Devices & Diagnostics

Why E-Scopics’ new Hepatoscope clearance could reshape point-of-care liver diagnostics

Liver diagnostics need speed and scale. E-Scopics’ Hepatoscope clearance tests whether bedside elastography can move deeper into routine care.

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Earflo FDA clearance turns pediatric ear pressure into a home-care market test
Medical Devices & Diagnostics

Can Earflo reduce ear tube surgery pressure with its FDA-cleared pediatric device?

Pediatric ear care has long had a waiting-room problem. Earflo’s FDA-cleared device tests whether home therapy can close the gap.

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Medical Devices & Diagnostics

CorVista Health expands machine-learning diagnostics to INOCA with new ACC.26 poster data

CorVista Health presents machine-learned non-invasive INOCA detection data at ACC.26. Analysis of what this means for cardiology and women's heart care. Read more.

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GE HealthCare pushes deeper into spectral imaging with Photonova Spectra FDA clearance
Medical Devices & Diagnostics

Photonova Spectra FDA clearance gives GE HealthCare a stronger hand in advanced CT imaging

GE HealthCare’s Photonova Spectra just won FDA clearance. Find out what this means for photon-counting CT, imaging workflows, and hospital adoption.

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QIAGEN wins FDA clearance for gastrointestinal panels on QIAstat-Dx Rise as syndromic testing platforms expand in U.S. labs
Medical Devices & Diagnostics

How QIAGEN’s QIAstat-Dx Rise GI panel clearance could reshape multiplex pathogen testing in clinical labs

QIAGEN wins FDA clearance for GI panels on QIAstat-Dx Rise. Discover what this means for syndromic testing platforms and molecular diagnostics adoption.

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Soterix Medical wins FDA clearance for SPRY transcranial magnetic stimulation therapy
Medical Devices & Diagnostics

FDA clears compact SPRY TMS system: can Soterix Medical disrupt the depression treatment market?

Soterix Medical wins FDA clearance for SPRY TMS in treatment-resistant major depression. What the clearance means for the neuromodulation market. Read the analysis.

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