Timetable for reforms of rules affecting medical devices not defined after calls for thorough impact assessment.
Read the full article at: www.euronews.com
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
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
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
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
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
MedTech industry news…
Read the full article at: www.medtechdive.com
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
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
The AI-enabled technology measures musculoskeletal structures from an MRI scan.
Read the full article at: www.mobihealthnews.com
