Elon Musk’s brain implant startup, Neuralink, and the University of California, Davis, have been accused of “egregious violations of the Animal Welfare Act” by the Physicians Committee for Responsible Medicine (PCRM), citing documents obtained through a public records lawsuit. The nonprofit — which successfully pressured U.S. medical schools including Johns Hopkins to stop using live […]
Implants
CereVasc wins FDA IDE approval to begin eShunt pilot study
CereVasc today announced that it received an FDA investigational device exemption approval to begin a trial of the eShunt for normal pressure hydrocephalus. The Boston-based company can initiate its pilot trial of the eShunt system in patients with normal pressure hydrocephalus (NPH). The eShunt device offers a minimally invasive treatment with the potential to result in […]
Second Sight Medical, Nano Precision Medical merging to create therapeutic implant company
Second Sight Medical Products (NSDQ:EYES) and Nano Precision Medical agreed to a merger deal that will result in a focus on drug-device medical implants. The two companies entered into a definitive agreement under which privately held Nano Precision Medical (NPM) will merge with a wholly-owned subsidiary of Second Sight in an all-stock transaction, with NPM […]
Paralyzed patients walk, swim and cycle with spinal cord neuromodulation implant
The latest iteration of a spinal cord stimulation implant has allowed three paralyzed patients to take steps independently on a treadmill within a day of their device’s activation, and to stand, walk, swim and pedal a bicycle after five months of rehab. In 2018, the technology helped a patient get out of his wheelchair and […]
Abbott confirms first implants of its dual-chamber leadless pacemaker system
Abbott (NYSE:ABT) announced today that it completed the first implants of its dual-chamber leadless pacemaker system in a clinical trial. The company’s prospective, multicenter, international, single-arm, pivotal investigational Aveir DR i2i study will evaluate the clinical safety and efficacy of the Aveir DR leadless pacemaker in patients indicated for a DDD(R) or dual-chamber bradycardia pacing […]
UnitedHealthcare to cover Abbott’s non-opioid neurostimulation therapy for nerve pain
Abbott (NYSE:ABT) announced today that UnitedHealthcare updated a medical policy that expands access to certain neurostimulation devices. UnitedHealthcare updated its “Implanted Electrical Stimulator for Spinal Cord” policy, increasing patient access to Abbott’s non-opioid dorsal root ganglion (DRG) neurostimulation device for treating chronic pain. The updated policy covers 26 million UnitedHealthcare commercial members and will go […]
FDA clears VySpine’s interbody fusion system
VySpine announced today that it received FDA 510(k) clearance for its ClariVy cervical interbody fusion (IBF) system. Tallahassee, Florida-based VySpine designed its ClariVy cervical IBF system for use in anterior cervical discectomy with fusion (ACDF) procedures. According to a news release, the ClariVy system includes cervical interbody fusion devices made from either PEEK Optima LT1 […]
The top 10 catheter innovations of 2021
Last year was a big year for catheter innovation as medtech companies large and small received regulatory approvals for devices ranging from TAVR to single-use endoscopes. Catheter innovations weren’t limited to just adults; Catheter-deployed devices for premature babies and toddlers were also approved and released. And catheter-based devices made up nearly half of last year’s Prix […]
Artivion announces positive trial results for its On-X mitral valve replacement
Artivion (NYSE:AORT) today announced positive results from a clinical trial for its On-X mechanical mitral valve replacement (MVR). Atlanta-based Artivion (formerly CryoLife) published results in The Annals of Thoracic Surgery. The Proact clinical trial, a multicenter, non-inferiority, two-arm study assessed whether, after an On-X MVR, patients could be safely managed with lower-intensity warfarin plus aspirin. […]
NeuroMetrix reports Q4 losses
NeuroMetrix (NSDQ:NURO) today reported fourth-quarter results that included a bottom-line slide. The Woburn, Massachusetts–based neurostimulation technology developer posted losses of $1 million, or 15¢ per share, on sales of $1.8 million for the three months ended Dec. 31, 2021, for a bottom-line dip deeper into the red on sales growth of 0.6%. NeuroMetrix develops the […]
FDA approves Medtronic’s spinal cord stimulation for chronic pain from diabetic neuropathy
Medtronic (NYSE:MDT) announced today the FDA approved its Intellis and Vanta neurostimulator for treating chronic pain. The approval covers the Intellis rechargeable neurostimulator and the Vanta recharge-free neurostimulator for the treatment of chronic pain associated with diabetic peripheral neuropathy. The new indication offers DPN patients access to Medtronic’s spinal cord stimulation (SCS) portfolio of both […]