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NeuroMetrix Gets FDA De Novo Authorization For Neuromodulation Device To Treat Fibromyalgia
NeuroMetrix plans to market the prescription-based Quell in the fourth quarter to US rheumatologists and pain medicine physicians.
Company Faces False Claims Charges For Disposable Rectal Probe Reuse
The Prometheus Group reportedly told health care providers that they could reuse probes that were part of its pelvic floor therapy system on multiple patients by covering them with a condom or the finger of a rubber glove.
Medicare Proposes NTAP For Breakthrough Treatment Of Spinal Condition
US Medicare has granted a new technology add-on payment (NTAP) for an innovative technology designed to treat adult spinal deformity.
UK On Cusp Of Integrated Care And New Regulatory Fees But Innovation Adoption Pressures Remain
New medtech regulatory policy, technology adoption challenges and NHS architecture changes under the new Health and Care Act will give system UK users much to ponder over this summer.
European Regulatory Roundup, April 2022: A Meaty Month For News And Analysis
April saw many more regulatory developments and documents compared to March, and also the promise of much to come over the near-term. With HTA and AI rules asking much more from the sector, these are demanding times for medtech.
Physician Sentenced In Reused-Catheter Scheme
The California doctor billed Medicare for $12m in unnecessary vein ablation procedures. He has been sentenced to 93 months in prison, three years’ probation, and must pay $4.5m in restitution.
With A New Director Elect, NICE Is On A Mission To Elevate Medtech
A refreshed NICE, soon to get a new medtech director, has set out a series of priorities that show an intent to bring medtech closer to the center of its activities.
The EU HTA Regulation: How It Threatens Device Launches And Where The Solutions Lie
Medtech needs to closely monitor how the newly adopted EU HTA Regulation is rolled out and actively seek to influence its impact to avoid major obstacles ahead. MedTech Europe’s Oliver Bisazza explains why further shaping of this new text is so critical.
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