Innovative Health Sciences announced today that it received CE mark approval in Europe for its Insignis syringe infusion system. Chester, N.Y.–based Innovative Health Sciences designed the Insignis syringe infusion system to offer a combination of intravenous and subcutaneous non-electric infusion with a selectable rate flow controller — the IV Controller and the OneSett. According to […]
Regulatory/Compliance
FDA approves Nevro spinal cord stimulation 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. Redwood City, Calif.-based Nevro’s Senza system’s approval is specific to Nevro’s 10 kHz stimulation, with the company touting that it now has the only spinal cord stimulation system approved by the FDA with a specific indication […]
Europe approves Roche’s Enspryng subcutaneous NMOSD treatment
Roche (SWX: RO, ROG) announced today that the European Commission approved its Enspryng subcutaneous NMOSD treatment. Basel, Switzerland-based Roche developed Enspryng (satralizumab) to treat adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD). Approval comes for the treatment as a monotherapy or for use in […]
Bionaut Labs receives orphan drug designation for its lead therapeutic
FDA has granted orphan drug designation to the drug-device startup Bionaut Labs (Los Angeles) for the company’s lead therapeutic program, BNL-101, for the local treatment of malignant gliomas. BNL-101 is a drug-device combination that brings together remote-controllable microscale robotics and the chemotherapy agent doxorubicin. In March, the startup received $20 million in funding from Khosla Ventures. […]
FDA extends NDA review period for Incyte’s atopic dermatitis therapeutic cream
Incyte (NSDQ:INCY) announced today that the FDA extended the review period for the new drug application for its ruxolitinib cream. Wilmington, Del.-based Incyte designed its ruxolitinib cream to treat atopic dermatitis (AD). The company designed the proprietary formulation of its selective JAK1/JAK2 inhibitor ruxolitinib for topical application, according to a news release. Currently, the ruxolitinib […]
NRx Pharmaceuticals touts Zyesami results, seeks EUA for treating COVID-19
NRx Pharmaceuticals (NSDQ:NRXP) announced that it applied for FDA emergency use authorization based on a study of its Zyesami therapeutic. Radnor, Pa.-based NRx Pharmaceuticals, formerly NeuroRx, just last week completed a merger with SPAC Big Rock Partners Acquisition Corp. and went public, changing its name in the process. The company develops Zyesami, a synthetic form […]
Medtronic wins CE mark for smart insulin pen, Guardian 4 sensor
Medtronic (NYSE:MDT) announced today that it received CE mark approvals for its InPen smart insulin pen and its Guardian 4 sensor. Fridley, Minn.-based Medtronic’s new European approvals cover expanded functionality of the InPen for multiple daily injections (MDI), along with approval for the Guardian 4 sensor that requires no fingersticks for calibration or diabetes treatment […]
Intersect ENT wins CE mark for Propel Contour sinus implant
Intersect ENT (NSDQ:XENT) announced today that it received CE mark approval for its Propel Contour sinus implant. Menlo Park, Calif.-based Intersect ENT designed its Propel Contour sinus implant to maintain patency and reduce inflammation while conforming to the sinus ostia (openings) through mechanical support and steroid delivery where needed to optimize sinus surgery outcomes. Get the […]
FDA issues draft clinical trial guidelines for neurostim, other devices to treat diabetes
The FDA today issued a draft guidance with recommendations for clinical trials for certain devices intended for treating diabetes. Included in the guidance are recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with type 2 diabetes mellitus, independent of medication delivery. Among the […]
Bigfoot Biomedical wins FDA clearance for smart insulin pen cap system
Bigfoot Biomedical announced today that it received FDA 510(k) clearance for its Bigfoot Unity diabetes management system. Milpitas, Calif.-based Bigfoot’s first-of-its-kind Bigfoot Unity system features connected smart pen caps designed to recommend insulin doses for diabetes patients using multiple daily injection (MDI) therapy, according to a news release. Bigfoot Unity smart pen caps offer on-demand […]
