The FDA today warned of “years of spot or nationwide shortages” of a number of surgical kits and implantable medical devices due to the closure of two medtech sterilization plants that use ethylene oxide (EO) and efforts in Georgia to close a third. Potentially affected surgical kits include those used in emergency Caesarean sections and […]
Implants
Hancock Jaffe touts 6-month results for VenoValve
Hancock Jaffe Laboratories (NSDQ:HJLI) said yesterday that six-month data from its in-human VenoValve study showed that the first five patients observed displayed improvements in all study endpoints. Principal investigator Dr. Jorge Hernando Ulloa reported that the patients showed 10% improvement in reflux, 2% improvement in disease manifestations (VCSS scores) and 13% improvements in pain (VAS scores) […]
The top 10 medical disruptors of 2020
For the past 17 years, the Cleveland Clinic has predicted what the top 10 medical disruptors will be for the following year. The list of technologies, cultivated by a panel of physicians and scientists at the clinic, was led by Dr. Michael Roizen, emeritus chief wellness officer. “Healthcare is ever-changing and we anticipate that these […]
Garwood Medical wins FDA breakthrough nod for biofilm disruption device
Garwood Medical Devices said today that it has won FDA breakthrough device designation for the BioPrax device for eliminating biofilm infections on prosthetic knee implants. BioPrax is a minimally invasive device designed to deliver a low-voltage electrical treatment to the surface of a knee implant and kill bacteria associated with biofilm infections. The device has […]
European spinal cord stim outfits GTX Medical and NeuroRecovery Technologies to merge
GTX Medical and NeuroRecovery Technologies today announced their merger into a global company for the development of neuromodulation therapies for spinal cord injuries. The two merging companies plan to develop the targeted epidural spine stimulation system, an implantable spinal cord stimulation platform designed to restore locomotion in patients with spinal cord injury with real-time motion […]
9 early medical devices that will horrify or amaze you
The movie Frankenstein inspired eight-year-old Earl Bakken to consider how electricity could restore life and health to the human body. Bakken went on to invent the first external cardiac pacemaker and to co-found medtech giant Medtronic in 1949. Bakken’s fascination with the effects of electricity on the human body continued throughout his career, and he amassed a collection of […]
Intarcia Therapeutics takes another run at FDA approval
Intarcia Therapeutics said last week that the FDA accepted its new drug application resubmission for ITCA 650 for the treatment of Type 2 diabetes mellitus. The Boston-based company originally resubmitted the NDA on Sept. 9. FDA told the company that it considered the NDA resubmission a complete class 2 response. The Prescription Drug User Fee Act […]
Study: Abbott, Edwards may have mislabeled hundreds of patient deaths
This report has been updated with comments from Edwards Lifesciences, Madris Tomes and the FDA. Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study. The study by JAMA […]
Restoration Robotics shareholders OK Venus Concept merger
Restoration Robotics (NSDQ:HAIR) said yesterday that its shareholders voted to approve its merger with Venus Concept. The shareholders voted on nine proposals at the company’s annual meeting last week, and the proposals that put the merger into effect were approved by approximately 85% of the outstanding shares, according to a news release. San Jose, Calif.-based Restoration […]
Medtronic launches trial for extravascular ICD
Medtronic (NYSE:MDT) said today that it launched a worldwide pivotal study to evaluate its extravascular implantable cardioverter defibrillator device for treating dangerously fast heart rhythms. The EV ICD system uses a device that is the same size as traditional, transvenous ICDs, but with a lead wire placed outside the heart and veins, designed to deliver defibrillation […]
FDA clears Exogenesis nano-modified hernia mesh
Exogenesis said yesterday that it won FDA 510(k) clearance for its hernia mesh implant for soft tissue repair in abdominal wall hernias and deficiencies. The Exogenesis mesh is made from polypropylene fibers warp-knitted together to create a device with large pores and minimum density and thickness, similar to current meshes on the market. It’s designed […]