Policy & Regulation
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FDA safety panel to weigh paclitaxel-coated stents, balloons
The advisory panel, which will meet for two days starting Wednesday, will examine mortality and causality issues surrounding the paclitaxel-coated devices sold by BD, Medtronic, Cook Medical, Philips and Boston Scientific.
By David Lim , Maria Rachal • UPDATED: June 18, 2019 at 9:32 a.m. -
As CMS decision on TAVR looms, a push for broader access
Proposed agency rules would lower the bar for hospitals performing the less invasive heart procedure, but would also raise the eligibility requirements to offer the treatment.
By Nick Paul Taylor • June 18, 2019 -
Health Canada seeks advice on device action plan next steps
The agency is asking for public comments on proposed rule changes that would require device makers to provide post-market safety information about products.
By Susan Kelly • June 17, 2019 -
Lloyd's exits notified body services, leaving UK with 3
The withdrawal comes as Europe faces major concerns about capacity ahead of the new MDR and IVD regs.
By Nick Paul Taylor • June 14, 2019 -
DHS warns of severe security flaw with BD infusion pumps
The department gave the BD Alaris Gateway Workstation vulnerability the maximum score on a standard grading scale.
By Nick Paul Taylor • June 14, 2019 -
FDA issues draft advice on biotin interference with diagnostic testing
A 2017 agency safety communication reported a patient dying after high levels of biotin interference resulted in falsely low troponin results. Troponin tests are often used to detect heart attacks.
By David Lim • June 13, 2019 -
AMA adopts measures to shape development, uptake of AI systems in healthcare
The policies seek to ensure developers of AI, not physicians, are liable for medical errors involving the technologies.
By Nick Paul Taylor • June 13, 2019 -
FDA posts draft guidance on testing of reproductive devices
The agency details how developers and manufacturers of assisted reproduction technology devices can perform mouse embryo assays to assess embryotoxicity.
By Nick Paul Taylor • June 13, 2019 -
OIG estimates Medicare overpaid $269M for sleep studies
OIG thinks the problems occurred because CMS failed to provide the oversight needed to stop payments for noncompliant claims.
By Nick Paul Taylor • June 13, 2019 -
Germany, Ireland push EU to assess device regs preparedness
The delegations think a significant reduction in notified bodies is likely but hope to avoid delaying implementation "unless absolutely necessary."
By Nick Paul Taylor • June 12, 2019 -
EU names UDI issuers in move to new medtech regs
Four organizations will support implementation of UDI systems under the new EU Medical Device Regulation and In Vitro Diagnostics Regulation.
By Susan Kelly • June 11, 2019 -
Quest, LabCorp breach stirs questions of cybersecurity risk from outside vendors
The breach could result in new regulations and rules governing how U.S. companies select and assess their vendors, according to Moody's.
By Rebecca Pifer • UPDATED: June 11, 2019 at 10:49 a.m. -
Medtech avoids tariff blow as US, Mexico reach deal
President Donald Trump late Friday called off plans for a 5% tariff set to go into effect today on imports from Mexico.
By Susan Kelly • June 10, 2019 -
Deep DiveInside Quest Diagnostics, LabCorp's supply chain breach
The intrusion happened inside the American Medical Collection Agency, but responsibility is shared through its partner ecosystem.
By Samantha Ann Schwartz • June 06, 2019 -
FDA approves DT MedTech's total ankle replacement implant
The company will aim to compete with Stryker and Zimmer Biomet.
By Nick Paul Taylor • June 06, 2019 -
House committee passes 6% increase in FDA funding
The committee wants one FDA priority, the Transform Medical Device Safety, Cybersecurity, Review, and Innovation initiative, to make do with the same level of funding as it received in fiscal 2019.
By Nick Paul Taylor • June 05, 2019 -
Device industry praises FDA AI/ML framework, asks for Class III software inclusion
AdvaMed and the Combination Products Coalition applauded the agency's work on a regulatory approach for the emerging technology, but gave a slew of recommendations for FDA to consider as it develops a potential draft guidance.
By David Lim • June 04, 2019 -
EMA posts draft guidance on drug-device combinations
The European Medicines Agency published the text to inform companies of their obligations under the regulations set to come into force across the continent next year.
By Nick Paul Taylor • June 04, 2019 -
FDA consults surgical device experts on down-classing certain hemostatic agents
Johnson & Johnson's Ethicon opposes loosening premarket requirements for the devices, maintaining strict controls are needed to ensure patient safety.
By Maria Rachal • May 31, 2019 -
DME industry ramps up lobbying efforts ahead of 2020 proposed rule
Key health lawmakers in the House and Senate are lending support to AAHomecare in its bid to prevent CMS from adding non-invasive ventilators to its competitive bidding program in 2021.
By David Lim • May 31, 2019 -
GS1 updates UDI guideline to reflect changes to FDA position
Among the almost 20 new subsections added by GS1 are several intended to help device companies get started with UDIs.
By Nick Paul Taylor • May 31, 2019 -
Medtech groups call for immediate action to avoid EU regulatory cliff
The trade groups think the system is "very unlikely" to be ready in time, raising fears of severe supply disruption.
By Nick Paul Taylor • May 30, 2019 -
Medtronic gets FDA greenlight to expand His-bundle pacing portfolio
The catheter system is designed to address the challenges of His bundle anatomy by giving physicians more maneuverability and an adjustable form.
By Nick Paul Taylor • May 30, 2019 -
Health Canada makes it official: Macrotextured breast implants off the market
Regulators concluded Allergan's Biocell surface implants boost the risk of developing cancer, outweighing potential benefits. The decision conflicts with FDA's stance citing insufficient evidence to support a U.S. ban.
By Maria Rachal • May 29, 2019 -
FDA experts meet to mull up-classing surgical staplers
Thursday's advisory panel meeting comes amid identification of adverse tissue reactions, infections and complications associated with device malfunction and user error — and 412 reports of death.
By Maria Rachal • May 29, 2019
