Axonics Modulation Technologies may be running against medtech giant Medtronic in the field of sacral neuromodulation for overactive bladder, but the smaller player is unfazed. Encouraging preliminary findings from its clinical study, revealed this week at the INS 2017 neuromodulation conference, is giving Axonics' technology the validation it needs. CEO Raymond Cohen is confident that the special features offered by the r-SNM system will galvanize what is already a fast-growing market.
Positive initial results from a multicenter clinical study of the r-SNM system for treating overactive bladder (OAB) has further consolidated Axonics Modulation Technologies Inc.'s standing as a notable rival – despite its modest stature – to medtech giant Medtronic PLC in the sacral neuromodulation (SNM) market.
The RELAX-OAB study was initiated in June last year, after the r-SNM system was CE marked, and it has enrolled...
The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.
This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.
The US agency said on 10 September that it plans to study whether heavy metals detected in tampons could endanger their users.
Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.
Point of care ultrasound technology that can be used by non-sonographers will plug gaps in workforce coverage and bring new critical care capabilities to the frontline of care, said Royal Philips.
The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.
