California Attorney General Rob Bonta announced a $26 billion settlement with Johnson & Johnson, among other companies, over opioids. The settlement includes Johnson & Johnson, which manufactured and marketed opioids, and pharmaceutical distributors Cardinal, McKesson and AmerisourceBergen. Get the full story at our sister site, Pharmaceutical Processing World.
Neuromodulation/Neurostimulation
NeuroMetrix’s Q2 earnings report sends its stock to new heights
NeuroMetrix (NSDQ:NURO) shares saw a huge boost this today on strong second-quarter revenues and an increased bottom line. NURO shares were up 19.1% at $24.77 per share in mid-afternoon trading. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 0.4%. The Woburn, Mass.-based company posted losses […]
The 18 most innovative medical devices of 2021
The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition. “The Awards Committee is excited to introduce the nominees for the 2021 […]
NeuroMetrix stock skyrockets on news of FDA breakthrough device designation
NeuroMetrix (NSDQ:NURO) today announced that its Quell device has received FDA breakthrough designation for treating fibromyalgia symptoms in adults. The news saw NURO shares nearly triple in value to $9.72 apiece near the close of trading. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up 1.5%. Fibromyalgia involves the […]
FDA approves Nevro’s Senza system to treat chronic pain with diabetic neuropathy
Nevro (NYSE:NVRO) announced today that it received FDA approval for its Senza system for treating chronic pain associated with PDN. The Redwood City, Calif.-based company’s stock was up nearly 6%, to 152.54 per share, by afternoon trading today. Nevro’s Senza system’s approval is specific to Nevro’s 10 kHz stimulation. The company is touting that it […]
Fresenius Kabi launches Simplist fentanyl citrate injection
Fresenius Kabi announced today that it initiated the U.S. introduction of a fentanyl citrate injection in the Simplist pre-filled syringe. Lake Zurich, Ill.-based Fresenius Kabi’s proprietary Simplist ready-to-administer prefilled syringe offers the fentanyl citrate injection at 50 mcg per 1 mL in an effort to reduce waste and diversion while ensuring the safe delivery of medication. […]
NeuroPace wins five-year $9.3M grant from NIH
NeuroPace today announced that it has received a $9.3 million National Institutes of Health grant to study Lennox-Gastaut Syndrome treatment. The NIH — through the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative — will provide up to $9.3 million over a five-year period to evaluate the use of Mountain View, Calif.-based NeuroPace’s RNS neuromodulation […]
Neuroelectrics wins FDA breakthrough device designation for its epilepsy-treating neuromod
Brain stimulation tech developer Neuroelectrics announced today that it’s secured FDA breakthrough device designation for its Starstim neuromodulation platform to treat refractory focal epilepsy. Starstim includes transcranial electrical stimulation (tES), personalized treatment protocols and a secure cloud-based mechanism to deliver treatment anywhere. “We are excited to receive the FDA Breakthrough Device Designation for our lead […]
Mainstay Medical launches implantable neurostim system in U.S.
Mainstay Medical today announced the limited commercial launch of its ReActiv8 implantable restorative neurostimulation system in the U.S. The Ireland-based company designed ReActiv8 to treat intractable chronic lower back pain. The system will be available in the U.S. through ReActiv8-certified physicians this summer. “Supported by more than 10 years of clinical research, ReActiv8 is the […]
Axonics files FDA PMA supplement for its non-rechargeable SNM system
Axonics (NSDQ:AXNX) announced that it filed a premarket approval supplement with the FDA for its sacral neuromodulation (SNM) system. Irvine, Calif.-based Axonics filed the PMA supplement for its newly developed, long-lived, non-rechargeable SNM implantable neurostimulator (INS), according to a news release. The company designed its new non-rechargeable SNM system to replicate the key features of […]
FDA approves Medtronic recharge-free spinal cord neurostim
Medtronic (NYSE:MDT) announced today that the FDA approved its Vanta recharge-free implantable neurostimulator (INS). Fridley, Minn.–based Medtronic touts the Vanta INS as having a device life of up to 11 years — more than twice the device life of competitive primary cell devices, according to a news release. Additionally, Vanta uses Medtronic’s proprietary AdaptiveStim technology […]
