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Enforcement & Litigation

Set Alert for Enforcement and Legislation

Settlements Announced In Three ‘Electro-Acupuncture’ False-Claims Cases; Charges Filed Against Billing Consultant

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

Policy Enforcement Medicare

CMS Webpage Promotes Medicaid’s Home And Community-Based Services Across US, Including Telehealth

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

Medicaid Telehealth

From Recalls To Clinical Trials, Medtronic’s Developing A ‘Systematic Approach’ To Capturing Patient Input

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.

Recalls Clinical Trials

Compliance Corner: Here’s How Stryker Decides Whether To Launch A Device Recall

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.

Compliance Corner Recalls

Notified Bodies Group: New Euro AI Regs Could Cause Undue Burdens

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.

Regulation Artificial Intelligence

CMS Should Create New Roadmap For Breakthrough Technologies, Trade Group Urges

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.

Medicare Policy

Settlements Announced In Three ‘Electro-Acupuncture’ False-Claims Cases; Charges Filed Against Billing Consultant

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

Policy Enforcement

Hear! Hear! Industry Responds To FDA Proposal On OTC Hearing Aids

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.

FDA OTC Devices

Rust Cause: Cook Recalls Medical Needles Because They Might Be Rusty

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.

Recalls Safety
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