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US FDA Advisory Panel Backs Claret’s Sentinel TAVR Filter

The panelists said the agency should approve the filter, which is used to protect the brain during transcatheter aortic heart-valve replacement surgery, despite ongoing questions about its effectiveness.

Cardiology Advisory Committees Medical Device
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Latest From United States , Policy &Regulation

Leap In US Sales Of IUDs Linked To Trump Election, ACA Repeal Efforts

Sales of contraceptive intrauterine devices rose in the 4th quarter of 2016 at some companies. The increase in interest in IUDs coincides with efforts to repeal Obamacare and eliminate contraceptive coverage guarantees, according to Planned Parenthood and AthenaHealth.

Gynecology & Urology Reimbursement

Warning Letter Roundup & Recap – Feb. 21, 2017

No device-related warning letters were released by US FDA the week of Feb. 21.

Device Warning Letters Regulation

CMS Nominee Seema Verma Urges Caution On Competitive Bidding Program

Seema Verma, President Trump’s pick to run the US Medicare agency, told the Senate Finance Committee that rural areas should not have to comply with CMS’ medical supplies competitive-bidding program if it is not a good fit. Verma was also questioned on changes she might make to the Affordable Care Act and the Medicare program, but did not offer many specifics.

Policy Reimbursement

Unusual False-Claims Settlement Cites GMP Issues

A recent Baxter settlement over moldy air filters shows a move for DOJ to enforce manufacturing quality violations as part of its False Claims Act activities.

Compliance Legal Issues

House Ways And Means Committee Membership, 115th Congress

The chart below displays the updated membership of the committee, which has important oversight on health and tax policy matters. It specifies which members sit on the Health Subcommittee.

Legislation Policy

House Panel Plans Oversight On Device Tax, MACRA, Trade Negotiations

The US House Ways and Means Committee will focus oversight actions this Congress on Affordable Care Act issues including device tax repeal, Health and Human Services priorities – including implementation of provider payment reforms – and overseas trade negotiations, the panel agreed Feb. 14.

Legislation Policy
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Latest From United States &Quality Control

Unusual False-Claims Settlement Cites GMP Issues

A recent Baxter settlement over moldy air filters shows a move for DOJ to enforce manufacturing quality violations as part of its False Claims Act activities.

Compliance Legal Issues

More Manufacturers Sign Up For Single Audits As MDSAP Becomes Operational

A growing number of medtech manufacturers have expressed interest in the Medical Device Single Audit Program since MDSAP became fully operational in January. The program has also drawn interest from regulatory agencies beyond those from the five participating countries, and a policy is being framed to admit new members.

Quality Control Compliance

Hospitals Prefer Existing Mechanisms To Report Device Safety Issues, Says AHA

The American Hospital Association says US FDA should build on existing safety efforts to gather evidence about medical device adverse events "rather than relying on a potentially duplicative event reporting structure," and the Medical Imaging Technology Alliance blamed device equipment servicing companies for failing to pass on information to the agency and manufacturers about equipment failures, in comments and testimony on the agency's plan to modernize evidence generation for device evaluation.

Quality Control Policy & Regulation
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