Finnish orthopedic device manufacturer Bone Index said it has won Medicare and Medicaid coverage for its Bindex point-of-care osteoporosis measurement device for ambulatory surgical and outpatient settings. Bindex measures the cortical bone thickness of the tibia and an algorithm calculates the density index, a parameter that estimates bone mineral density at the hip as measured with a […]
SPR Therapeutics’ new PNS system wins FDA nod
The FDA has approved SPR Therapeutics’ (Cleveland) Sprint endura (single lead) and extensa (dual lead) peripheral nerve stimulation (PNS) systems. The minimally invasive Sprint system is the only FDA-approved percutaneous PNS system that is indicated for up to 60 days in the back and/or extremities for both chronic and acute pain and is the industry’s only dual lead […]
Study slams FDA’s ‘fast-track’ approval process
More than 98% of the 161 foot and ankle implants that were recalled from 2007 through 2017 were approved through the FDA’s 510(k) process, according to a new study. That left one recalled device approved via the more stringent premarket approval (PMA) process and two for which the submission procedure was not indicated. The 510(k) process allows […]
SpaceLabs’ Arkon anesthesia system recalled again
The FDA has slapped SpaceLabs Healthcare with a Class 1 recall of its Arkon anesthesia delivery system for going into a “failed state” on numerous occasions since 2013. The recall covers 253 units. No injuries or deaths were reported. During the failed state, the mechanical ventilation function stops working while the machine is in use […]
Envoy Medical’s hearing implant wearers can get MRIs
The FDA has given Envoy Medical’s landmark Esteem middle-ear implant clearance for MR-conditional labeling in both 1.5 and 3.0 Tesla (T) scanning environments. White Bear Lake, Minn.-based Envoy introduced the Esteem — the first fully implantable device to treat hearing loss in the U.S. — in 2010. Surgeons and audiologists who work closely with hearing […]
Sensus squeaks past Wall Street Q2 expectations
Sensus Healthcare (NSDQ:SRTS), narrowly beat analysts’ earnings expectations for the second quarter but missed the consensus sales forecast, sending share prices down today. Boca Raton, Fla.-based Sensus posted net losses of -$540,651, or -4¢ per share, on sales of $6.1 million for the three months ended June 30, cutting its losses by -29.2% on sales growth […]
Pulse Biosciences’ nano-pulse stimulation tested in skin cancer patients
Pulse Biosciences, Inc. (Nasdaq:PLSE) has begun a clinical study to evaluate nano-pulse stimulation (NPS) platform in a common skin cancer, basal cell carcinoma (BCC). NPS is a non-thermal therapy that uses ultra-short, nanosecond-pulsed electric fields that directly affect and disrupt intracellular structures. It has been shown to induce immunogenic cell death in pre-clinical cancer models, according […]
Integer adds radial introducer for patients with smaller arteries
Integer’s new radial access introducer kit for interventional cardiology and peripheral vascular procedures has won FDA clearance and the CE Mark. RadialSeal was engineered for optimal device compatibility and ease of insertion, the company said in a statement. Its thin-walled sheath design minimizes outer diameter while maximizing inner diameter, according to Payman Khales, president of Integer’s cardiovascular division. The […]
CarboFix wins FDA nod for its carbon/PEEK pedicle screws
CarboFix Orthopedics Ltd. has won FDA approval for a spinal screw system for use in people with advanced spinal cancer. The CarboClear carbon fiber pedicle screw system was designed to restore the integrity of the spinal column, even in the absence of fusion, for a limited time period in patients with advanced-stage thoracic and lumbar spine […]
Netflix’s ‘The Bleeding Edge’ blasts medtech & FDA
Netflix has unleashed a blistering indictment of the medical device industry, the FDA and doctors who accept money from medtech in its new documentary, ‘The Bleeding Edge,’ released today. The film depicts people who have suffered injuries and/or illnesses following placement of Bayer’s Essure sterilization device, Johnson & Johnson’s vaginal mesh, various manufacturers’ metal artificial […]
Endomagnetics’ device could help ID cancerous lymph nodes
The FDA has approved Endomagnetics Inc.’s magnetic device system for guiding lymph node biopsies in breast cancer patients undergoing a mastectomy. The Sentimag Magnetic Localization System detects magnetic seeds or a magnetic drug to identify the specific lymph nodes to which cancer cells are most likely to spread from the original tumor. A biopsy of […]
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