September’s approvals include the US FDA’s approval of Axonics sacral neuromodulator for fecal incontinence and AMO’s Star S4 IR excimer laser for photorefractive keratectomy.
The US Food and Drug Administration approved one original PMA and one panel-track PMA supplement in September. The FDA cleared no de novos in September.
On 9 September, the FDA approved an original PMA for Axonics Modulation Technologies Inc.’s rechargeable sacral neuromodulation (r-SNM) system for treating chronic fecal incontinence in patients who have failed...
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Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
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.
