Enforcement & Litigation

Through home and community-based services, Medicaid beneficiaries can receive support and tap into program services from home.

The medtech behemoth is putting in place a company-wide framework to make sure the voice of the patient is heard across the firm’s premarket and postmarket activities.

Stryker Corp. regulatory expert Ommeed Shahrokh explains the device giant’s decision-making process around product recalls and describes what’s included in recall letters to customers.

The European medical devices notified bodies association says a proposed rule published earlier in the year risks forcing manufacturers, regulators and notified bodies to duplicate their work.

The Medical Device Manufacturers Association wants the US Medicare agency to come up with a new rule for implementing a coverage pathway for breakthrough devices by June 2022.

Fraudsters have reportedly billed the government for the treatment, which uses electric impulses to replace the traditional needles of acupuncture.

The FDA’s recent proposal to allow hearing aids to be sold over the counter without a prescription has mostly been met with approval. Many Americans, however, are unaware of the plan.

Cook Medical recalled its Transseptal Needle and Transseptal Needle with Catheter on 18 October because there could be rust on the outside or inside of the product.