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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.

FDA Launches

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.

Legal Issues Regulation

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.

Medicare Reimbursement

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.

United Kingdom Market Access

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.

EU Europe

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.

Legal Issues Regulation

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.

United Kingdom Health Technology Assessment

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.

EU Europe
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