European Parliament softens stance on overhaul of medical device rules | Euronews
Timetable for reforms of rules affecting medical devices not defined after calls for thorough impact assessment.
Read the full article at: www.euronews.com
Continue Reading »Vy Spine receives FDA clearance for 3D printed LumiVy OsteoVy PEKK Lumbar IBF device
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
Continue Reading »FDA Grants Expanded Clearance of Intravascular Imaging System for Use with Percutaneous Coronary Interventions
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
Continue Reading »Now is the Time to Prioritize IoT Medical Device Security | Healthcare IT Today
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
Continue Reading »Surmodics receives FDA clearance for its thrombectomy system (NASDAQ:SRDX)
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
Continue Reading »MEPs push Commission to re-open EU medical device law quickly | Euronews
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.
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OrthAlign receives FDA 510(k) clearance for handheld THA application
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
Continue Reading »FDA Clears Abionic’s IVD CAPSULE PSP for Early Detection of Sepsis
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
Continue Reading »Springbok Analytics receives FDA 510(k) clearance for MuscleView
The AI-enabled technology measures musculoskeletal structures from an MRI scan.
Read the full article at: www.mobihealthnews.com
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