Under changes announced on 9 October by the US Health and Human Services Office of Inspector General (HHS OIG) and the Centers for Medicare and Medicaid Services (CMS), new so-called "safe harbors" to the anti-kickback statute and planned changes to the physician self-referral statute (Stark Law) would shelter health-care providers – including device-makers – who enter into value-based care arrangements for services paid for by Medicare. Such changes have been promoted by medtech firms.
Three new so-called "safe harbors" proposed by the US Department of Health and Human Services Office of Inspector General (HHS 0IG) on 9 October would allow health-care providers to enter into more value-based care arrangements without triggering anti-kickback statute (AKS) violations.
The same day, the Centers for Medicare and Medicaid Services (CMS) proposed changes to physician self-referral regulations under the...
The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.
Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting inconsistencies during audits. The report recommends automation and better data governance.
The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.
2026 reimbursement calculations for the list of hybrid DRGs – a mechanism to incentivize day cases over inpatient surgery – will be issued in few weeks’ time. The medtech industry has made its demands known.
The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.
