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Home»Posts tagged with»FDA 510(k)

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

By Pallavi Madhiraju on May 16, 2026   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.

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

By Pallavi Madhiraju on May 12, 2026   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.

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

By Pallavi Madhiraju on May 9, 2026   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.

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

By Pallavi Madhiraju on May 3, 2026   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.

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

By Pallavi Madhiraju on April 25, 2026   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!

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

By Pallavi Madhiraju on March 29, 2026   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.

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

By Pallavi Madhiraju on March 3, 2026   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.

Dror Ortho-Design advances U.S. commercialization with next-generation ZSmile Platform

By Soujanya Ravi on February 19, 2026   Medical Devices & Diagnostics  

Dror Ortho-Design advances U.S. commercialization with next-generation ZSmile Platform

Dror Ortho-Design secures FDA clearance for ZSmile. Explore what pneumatic aligners mean for orthodontic innovation and adoption.

What Applied Medical Technology’s Explant Express FDA clearance reveals about breast implant explantation workflows

By Pallavi Madhiraju on February 14, 2026   Medical Devices & Diagnostics  

What Applied Medical Technology’s Explant Express FDA clearance reveals about breast implant explantation workflows

FDA clears Explant Express for ruptured breast implant removal. Explore what this means for surgical workflows, adoption risks, and explantation standardisation.

What KORU Medical’s RYSTIGGO delivery clearance means for subcutaneous infusion models

By Pallavi Madhiraju on January 30, 2026   Medical Devices & Diagnostics  

What KORU Medical’s RYSTIGGO delivery clearance means for subcutaneous infusion models

KORU Medical’s FreedomEDGE gets FDA clearance for RYSTIGGO delivery in clinics. Find out how this expands access to gMG therapy and reshapes infusion workflows.

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