Medtronic (NYSE:MDT) and Axonics (NSDQ:AXNX) could see their patent dispute over neurostimulation technology resume in court. Yesterday, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office affirmed an additional three patents in a long-term dispute between the companies over intellectual property for Medtronic’s Interstim sacral neuromodulation (SNM) system, completing the review process […]
Neurological
Medtronic’s Pipeline Flex problems expand
The FDA today issued a notice confirming a Class I recall of the Pipeline Flex embolization device from Medtronic (NYSE:MDT). Several models of the Pipeline Flex embolization device and Pipeline Flex embolization device with Shield Technology were affected, with 8,825 devices recalled in the U.S., having been distributed between April 18, 2019, and Aug. 13, […]
European regulators offer positive opinion on Janssen’s schizophrenia treatment
Johnson & Johnson’s Janssen Pharmaceutical Companies today announced a positive CHMP opinion on its Byannli schizophrenia treatment. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued the positive opinion. The committee recommended using long-acting atypical antipsychotic Byannli (6-monthly paliperidone palmitate; PP6M) therapy for the maintenance treatment of schizophrenia. The recommendation […]
Pear Therapeutics touts real-world data for reSET-O prescription digital therapeutic
Pear Therapeutics today announced the publication of positive results from real-world data of its reSET-O prescription digital therapeutic. Boston-based Pear Therapeutics evaluated its FDA-authorized reSET-O PDT in the treatment of opioid use disorder (OUD) on patients treated for 24 weeks, with real-world evidence demonstrating that the treatment is associated with improved outcomes, high levels of treatment […]
InTRAvent wins FDA 510(k) clearance for Solopass bedside neuro-navigation device
InTRAvent has announced FDA 510(k) clearance of its Solopass system for assisting frontal placement of intraventricular catheters deep within the brain. The Hershey, Pennsylvania-based company said yesterday that it designed the device with 2D and 3D ultrasound imaging, artificial intelligence and trajectory guidance for intraprocedural localization and navigation for external ventricular drain (EVD) placement. Get […]
Axonics loses IP challenge to Medtronic patents
Medtronic (NYSE:MDT) announced that it picked up three victories in an intellectual property (IP) dispute against Axonics (NSDQ:AXNX) over sacral neuromodulation devices. According to a news release, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) rejected Axonics’ attempt to invalidate three Medtronic patents in its IP infringement lawsuit related to Medtronic’s […]
FDA clears NeuroOne’s Evo sEEG electrode
NeuroOne Medical Technologies (NMTC) announced that it received FDA 510(k) clearance for its Evo sEEG electrode technology. Eden Prairie, Minnesota-based NeuroOne’s Evo sEEG electrode technology received clearance for temporary (less than 24 hours) recording, monitoring and stimulation of electrical signals at the subsurface level of the brain, according to a news release. The Evo sEEG […]
Impel NeuroPharma prices $45M offering following FDA approval for migraine treatment
Impel NeuroPharma (NSDQ:IMPL) announced that it priced an underwritten public offering of common stock worth $45 million. The offering includes 3 million shares of common stock priced to the public at $15 per share, with gross proceeds set to total $45 million before deducting underwriting discounts and commissions and other offering expenses payable by Impel NeuroPharma. […]
Report: Congressional committees have questions over Biogen’s Alzheimer’s drug
The FDA’s relationship with Biogen is under scrutiny following the controversial approval granted to the company’s Aduhelm Alzheimer’s drug. According to a report from Endpoints News, the House Energy & Commerce and Oversight committee chairs issued a letter this week requesting that acting FDA Commissioner Dr. Janet Woodcock and the FDA provide very specific information by Sept. 16, […]
FDA approves Impel NeuroPharma’s nasal spray for treating migraines
Impel NeuroPharma (NSDQ:IMPL) announced today that the FDA approved its Trudhesa nasal spray for treating migraine in adults. Seattle-based Impel NeuroPharma plans to launch Trudhesa commercially early next month. The company’s shares took a massive hit, though, dropping -19.3% at $18.65 per share by market close and continuing to slide down -0.8% at $18.50 after hours […]
FDA approves MicroTransponder’s stroke rehab neurostim system
The FDA announced today that it approved the MicroTransponder Vivistim paired VNS system for chronic ischemic stroke rehabilitation. MicroTransponder designed its Vivistim System as a first-of-its-kind, drug-free rehabilitation system for treating moderate to severe upper extremity motor deficits associated with chronic ischemic stroke using vagus nerve stimulation, according to an FDA news release. Vivistim electrically […]
