The FDA has issued a warning letter to Orchid Orthopedic Solutions, a major design and manufacturing outsourcer in the orthopedic medical device space, for alleged violations including unsanitary water used to clean implants. The letter, dated May 13 and released today, says the company’s facility at 23149 Commerce St., Farmington Hills, Mich. failed to adequately […]
J&J ordered to pay $80 million in Pennsylvania pelvic mesh case
A Philadelphia jury has awarded a woman $80 million for injuries caused by pelvic mesh manufactured by Johnson & Johnson’s Ethicon subsidiary, according to media reports. The award includes $50 million in punitive damages and $30 million in compensatory damages — the largest compensatory damages verdict to date in a pelvic mesh case, a company […]
Louisiana prisoners to get non-FDA-approved BioCorRx implant
BioCorRx (OTC:BICX) has begun a controversial pilot program to provide soon-to-be-released Louisiana prison inmates an opioid addiction treatment implant that has not been approved by the FDA. The pilot, announced last week, has drawn praise from corrections officials and concern from prisoner advocates and some medical professionals, according to a report in The Advocate, a Baton Rouge, La. newspaper. Ten […]
Report: Johnson & Johnson to settle metal-on-metal hip cases for $1B
Most of the remaining metal-on-metal hip cases facing Johnson & Johnson (NYSE:JNJ) subsidiary DePuy could reportedly be settled for about $1 billion. The deal, which includes a prior $400 million settlement, covers about 95% of the 6,000 cases involving Pinnacle hip implants that had to be removed, Bloomberg reported, citing two “people with knowledge of […]
Abbott launches smartphone-connected Confirm Rx implantable cardiac monitor
Abbott (NYSE:ABT) said today that it is launching its next-generation, FDA and CE Mark cleared, smartphone-connectable Confirm Rx implantable continuous cardiac monitor. The Chicago-area medical device maker said that the newly launched next-gen Confirm Rx is a paper-clip sized implantable device intended for the remote monitoring of unpredictable heart rhythm problems, and is intended to produce […]
Intersect ENT wins preliminary CMS reimbursement code
Shares in Intersect ENT (NSDQ:XENT) got a boost yesterday on news that the Centers for Medicare and Medicaid Services (CMS) had assigned the company’s Sinuva corticosteroid-eluting sinus implant a preliminary J-code. Intersect ENT stock, which had been bumping along just under $30 per share last week, jumped to $33.13 per share at Monday’s market open, then […]
NuVasive touts results of PEEK implant study
NuVasive (NSDQ:NUVA) today announced the results of a study that showed its Cohere porous polyetheretherketone (PEEK) implant improved early outcomes over structural allograft and smooth PEEK in anterior cervical discectomy and fusion (ACDF) procedures. In the study of 167 patients with degenerative cervical disc disease, those who underwent ACDF using Cohere porous PEEK exhibited significant […]
The grim stories behind seven of medtech’s worst failures
Medical devices save or restore thousands of patient lives every year, but the dark side to medtech innovation is increasingly drawing attention. For all the good the industry does, it’s worth remembering that the costs can be high – even fatal – when medical device companies don’t get things right. The examples range from women […]
FDA bans Boston Sci, Coloplast sales of pelvic mesh
The FDA has ordered Boston Scientific (NYSE:BSX) and Coloplast — the only remaining companies that sell pelvic mesh in the U.S. — to immediately halt sales and distribution of those products. The two companies have not demonstrated a “reasonable assurance of safety and effectiveness for these devices” used to treat pelvic organ prolapse (POP) since the […]
Glaukos touts 5-year study of glaucoma stents
Glaukos (NYSE:GKOS) said today that a study of its iStent trabecular micro-bypass stents reduced eye pressure in glaucoma patients five years after implant. The same study showed that significantly fewer iStent patients needed add-on medications after five years, the company said. The study showed that newly diagnosed, primary open-angle glaucoma (POAG) patients who received two […]
AirXpanders touts study results
AirXpanders (ASX:AXP) said that a retrospective clinical study has concluded that the use of its AeroForm tissue expanders may be associated with reduced infection rates, less medical treatment and lower costs for patients and health systems. The Palo Alto-based company makes the AeroForm tissue expander for post-mastectomy breast reconstruction. The device is designed to expand and […]
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