Among the latest round of applicants announced Dec. 26 for the hospital inpatient, new-technology add-on payments are five device makers: Boston Scientific (Watchman), CardioMEMS (Champion HF), Abbott Vascular (MitraClip), NeuroPace (RNS), and Aptus Endosystems (Heli-FX EndoAnchor).
CMS announced the latest round of applicants for new-technology add-on payments under the acute inpatient prospective payment system for FY 2015 on Dec. 26. Of the seven applicants, five are device- makers and two are pharmaceutical companies. CMS has scheduled a town hall meeting Feb. 12 to discuss the applications.
To win an add-on payment a device has to meet the criteria of being sufficiently new; it must have a...
EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.
A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.
US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the
The US House of Representatives passes legislation requiring manufacturers of non-flushable wet wipes to label products as ‘non-flushable," a move endorsed by the Personal Care Products Council.
US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the
The US House of Representatives passes legislation requiring manufacturers of non-flushable wet wipes to label products as ‘non-flushable," a move endorsed by the Personal Care Products Council.
The pulsed-field ablation market is surging, with the UK NHS opening doors and FDA updates for major players. Medtech Insight spoke with Steven Mickelsen, founder of Farapulse (the first clinically approved PFA system), about the sector's growth and his new venture, Field Medical.
