Pelvalon CEO Miles Rosen talks the company’s journey from US FDA de novo authorization to Medicare HCPCS payment code for its Eclipse System, a nonsurgical device used for bowel control in women.
Manufacturers looking to gain reimbursement from the US Centers for Medicare and Medicaid Services (CMS) for a novel medical device would be wise to heavily invest in clinical research and collect an abundance of clinical evidence.
That’s one key takeaway from Medtech Insight’s chat with Pelvalon CEO Miles Rosen, whose technology – the Eclipse System – was recently granted a new Healthcare Common Procedure Coding System...
German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.
Medtronic expects operating profit to grow approximately 7% in fiscal 2026, excluding tariff impacts. If tariffs materialize at the upper end of the projected range, operating profit growth could drop by 2.2 to 3.2 percentage points.
Announced after three years of negotiation, the FTA eliminates tariffs on 99% of Indian product types, covering nearly all trade value, and reduces tariffs on 90% of UK products. Although not yet formally signed, the deal is being positioned by the Indian government as “transformative,” with an estimated economic impact of $6.4bn for the UK alone by 2040.
