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FDA 510(k)

PharmaDeviceNews FDA 510(k)
Representative image of a robotic-assisted surgery system in a modern operating room, illustrating how Medtronic’s Hugo expansion filings could intensify competition in U.S. surgical robotics.
Medical Devices & Diagnostics

Medtronic pushes Hugo toward broader U.S. adoption as robotic surgery competition intensifies

Medtronic’s Hugo filings could widen U.S. robotic surgery competition. Find out how the FDA review may challenge Intuitive Surgical.

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Representative image of clinicians reviewing AI-enabled radiation therapy planning scans, illustrating how GE HealthCare’s MIM Contour ProtégéAI+ 2.0 FDA clearance could speed precision cancer treatment workflows.
Medical Devices & Diagnostics

GE HealthCare’s MIM Contour ProtégéAI+ clearance raises the stakes in radiotherapy automation

GE HealthCare’s MIM Contour ProtégéAI+ 2.0 clearance could speed radiation therapy planning. Find out what changes next.

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Representative image of an ultrasound exam in a modern imaging clinic, illustrating how Philips’ Elevate Plus FDA clearance could bring AI-enabled workflow support into routine diagnostic ultrasound.
Medical Devices & Diagnostics

How Philips’ Elevate Plus could change abdominal, breast and thyroid ultrasound workflows

Philips’ Elevate Plus puts AI inside ultrasound workflows. The real test is whether hospitals see faster scans and fewer repeat exams.

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Representative image of a clinician reviewing an implantable neuromodulation device in a urology setting, as BlueWind Medical raises $47.8 million to accelerate commercialisation of its Revi System for urgency urinary incontinence treatment.
Medical Devices & Diagnostics

Why BlueWind Medical’s $47.8m raise matters for the next phase of UUI treatment

UUI devices have clinical momentum. BlueWind Medical’s next challenge is proving Revi can scale through access, reimbursement, and workflow adoption.

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Representative image: A cuffless fingertip blood pressure monitoring device shows how Biozen’s FDA-cleared BP1000 could make calibration-free hypertension checks more accessible for home care and remote patient monitoring.
Medical Devices & Diagnostics

Can Biozen turn cuffless blood pressure from medtech promise into clinical reality?

Cuffs are accurate but inconvenient. Biozen’s FDA-cleared BP1000 tests whether fingertip blood pressure checks can change hypertension care.

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Representative image of a noninvasive abdominal sensor used in a clinical bladder function assessment, highlighting how Bright Uro’s FDA-cleared Glean Abdominal Sensor could support catheter-free urodynamics and real-world evaluation of bladder dysfunction.
Medical Devices & Diagnostics

Can Bright Uro’s new sensor finally make bladder testing less uncomfortable?

Bladder testing needs better real-world data. Bright Uro’s FDA-cleared sensor may push urodynamics beyond catheter-heavy workflows.

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Representative image of an advanced endoscopic ultrasound-guided gastrointestinal drainage procedure, reflecting TaeWoong Medical USA’s FDA-cleared SPAXUS stent and the growing role of minimally invasive therapeutic EUS in pancreatic pseudocyst, walled-off necrosis, and high-risk gallbladder drainage care.
Medical Devices & Diagnostics

Why TaeWoong Medical USA’s SPAXUS clearance could sharpen the race in therapeutic EUS

Therapeutic EUS is getting more competitive. TaeWoong Medical USA’s SPAXUS clearance now faces the harder test: real-world adoption.

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Representative image of a neurovascular catheter procedure, reflecting Sonorous Neurovascular’s FDA-cleared BosCATH device and its role in complex cerebral venous and arterial interventions.
Medical Devices & Diagnostics

Why Sonorous Neurovascular’s BosCATH FDA clearance could matter more than it first appears

Find out how Sonorous Neurovascular’s BosCATH FDA clearance strengthens its neurovascular access strategy today!

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Representative image of an electrocardiogram-based artificial intelligence workflow highlighting the broader clinical relevance of Anumana’s FDA-cleared ECG-AI algorithm for early pulmonary hypertension detection.
Medical Devices & Diagnostics

What Anumana’s FDA-cleared pulmonary hypertension algorithm means for cardiovascular AI

Anumana won FDA clearance for an ECG-AI pulmonary hypertension tool. Read what it changes for diagnosis, workflow adoption, and cardiovascular AI strategy.

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Can eyonis LCS deliver real-world impact beyond regulatory milestones in lung cancer screening
Medical Devices & Diagnostics

What FDA clearance means for Median Technologies eyonis LCS in a crowded AI radiology market

Median Technologies advances eyonis LCS after FDA clearance. Discover what this means for AI lung cancer screening and European expansion.

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