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Home | About | Blog

European Parliament softens stance on overhaul of medical device rules | Euronews

Posted on October 28, 2024

Timetable for reforms of rules affecting medical devices not defined after calls for thorough impact assessment.

Read the full article at: www.euronews.com

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Vy Spine receives FDA clearance for 3D printed LumiVy OsteoVy PEKK Lumbar IBF device

Posted on

The device is indicated for intervertebral body fusion for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.

Read the full article at: www.tctmagazine.com

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FDA Grants Expanded Clearance of Intravascular Imaging System for Use with Percutaneous Coronary Interventions

Posted on

The Gentuity HF-OCT Imaging System, which includes the 1.8 F Vis-Rx Micro-Imaging Catheter, is reportedly the first intravascular imaging system to garner a specific indication for pre- and post-intervention assessments of coronary vessels.

Read the full article at: www.diagnosticimaging.com

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Now is the Time to Prioritize IoT Medical Device Security | Healthcare IT Today

Posted on

The following is a guest article by Alex Rybak, Senior Director of Product Management at Revenera Pacemakers, insulin pumps, CT systems, wearables; these and many more medical devices are increasingly common parts of contemporary healthcare treatments.

Read the full article at: www.healthcareittoday.com

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Surmodics receives FDA clearance for its thrombectomy system (NASDAQ:SRDX)

Posted on

Surmodics (SRDX) received U.S. Food and Drug Administration 510(k) clearance for its Pounce XL Thrombectomy System.

Read the full article at: seekingalpha.com

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MEPs push Commission to re-open EU medical device law quickly | Euronews

Posted on

The European Commission is wavering over whether to revise long-delayed EU rules for medical devices such as syringes, pacemakers, and breast implants, but many lawmakers want it to move faster to avoid gumming up the market.

Read the full article at: www.euronews.com

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iRhythm’s Zio AT design changes win FDA clearance

Posted on

MedTech industry news…

Read the full article at: www.medtechdive.com

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OrthAlign receives FDA 510(k) clearance for handheld THA application

Posted on

OrthAlign Inc. has announced the FDA clearance of its Lantern handheld hip arthroplasty technology, designed to enhance positioning for direct anterior hip arthroplasty procedures. The device includes accelerometers and gyroscopes to improve navigation during total hip arthroplasty in the supine…

Read the full article at: dataemia.com

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FDA Clears Abionic’s IVD CAPSULE PSP for Early Detection of Sepsis

Posted on

Abionic, a Vaud-based medical diagnostics company, announced that its IVD CAPSULE PSP test received 510(k) clearance from the FDA.

Read the full article at: bioalps.org

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Springbok Analytics receives FDA 510(k) clearance for MuscleView

Posted on

The AI-enabled technology measures musculoskeletal structures from an MRI scan.

Read the full article at: www.mobihealthnews.com

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