Duodenoscope studies find higher-than-expected contamination rate, FDA says

Across studies run by Olympus, Fujifilm and Pentax, 6% of sampled devices were contaminated with microorganisms including pathogenic strains such as E. coli.

By Nick Paul Taylor • Dec. 11, 2018

Cybersecurity priorities laid out by key House panel

The House Energy and Commerce Committee issued a report outlining six strategies for strengthening the nation's defenses against cybersecurity vulnerabilities with a focus on medical devices in healthcare.

By Susan Kelly • Dec. 10, 2018

Explore the Trendline➔

Top 5 stories from MedTech Dive

From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

FDA to revisit transvaginal mesh issues at February meeting

The agency said it may consider additional regulatory actions based on public feedback and Feb. 12 advisory panel discussions.

By Susan Kelly • Dec. 10, 2018

FDA guide unveils vision for cancer diagnostics

The proposal came the same day lawmakers released an updated draft bill that would grant FDA authority to oversee in vitro clinical tests, such as test kits and laboratory developed tests.

By David Lim • Dec. 7, 2018

AdvaMed, MITA offer feedback on CDRH guidance priorities

Industry groups backed some of the FDA's device center proposals for fiscal year 2019 and added a few of their own.

By Maria Rachal • Dec. 7, 2018

FDA seeks to boost use of De Novo pathway with proposed rule

The increased clarity intended for the regulatory framework and application process could incentivize manufacturers to establish new predicates, aligning with the agency's plan to phase out older ones.

By Maria Rachal • Dec. 5, 2018

FDA endorses open database for genetic variants

The agency said it hopes the move will encourage database administrators to submit genetic variant information to publicly accessible databases, with the aim of spurring advancements in precision medicine.

By Susan Kelly • Dec. 5, 2018

Bipartisan bill introduced in Senate to penalize Medicaid gaming

The incoming leaders of the Senate Finance Committee want to set monetary penalties for companies that misclassify products within Medicaid.

By Andrew Dunn • Dec. 5, 2018

ACLA appeals lab payment suit to higher court

A watchdog report on Medicare lab payments will not help the industry's case, analysts said.

By David Lim • Dec. 5, 2018

FDA classifies Medtronic's ventilator correction a Class I recall

The software update addresses user interface problems that led Australian regulators to suspend the device.

By Nick Paul Taylor • Dec. 5, 2018

OIG finds Medicare overpaid $34M to device suppliers over three years

The overpayment stems from improper billing for prosthetics and other devices used at inpatient facilities.

By Nick Paul Taylor • Dec. 5, 2018

Medicare could overpay billions for lab tests: GAO

Medicare's new method of calculating payment rates for laboratory tests was intended to save the government money but could instead end up costing CMS as much as $10.3 billion over three years.

By Susan Kelly • Dec. 3, 2018

Person of the Year: Bakul Patel, FDA

The regulator has drawn praise from Commissioner Scott Gottlieb and others for his Software Pre-Cert Program work.

By David Lim • Dec. 3, 2018

Disruption of the Year: EU regulatory overhaul

It’s a "pendulum swing," said Rajesh Misra, principal in KPMG's technology enablement practice. "More and more as we talk to clients, this is coming across as a bigger transformation than they originally thought … impacting [their] entire life cycle."

By Meg Bryant • Dec. 3, 2018

The MedTech Dive Awards of 2018

The awards recognize the industry's top disruptors and newsmakers. These officials and companies are shaking up the medical technology sector and shaping the future.

By MedTech Dive Team • Dec. 3, 2018

FDA's De Novo pathway is about to get a makeover

"Particularly with really low risk devices, it can be challenging both from FDA's perspective and industry's perspective in terms of how much data is needed," Allyson Mullen, an attorney at Hyman, Phelps & McNamara told MedTech Dive.

By Meg Bryant • Dec. 3, 2018

UK and EU inch toward regulatory cooperation after Brexit

As the leave date looms next March, a political declaration notes the bloc will explore the possibility of cooperation by U.K. authorities with agencies like the European Medicines Agency.

By Suzanne Elvidge • Dec. 3, 2018

FDA offers more study options for CLIA waivers in redrafted guidances

The agency added new test design alternatives for manufacturers seeking waivers for IVD devices, a nod to a push from AdvaMed and others.

By Maria Rachal • Nov. 30, 2018

FDA issues draft guidance on blood glucose monitors

The agency said distinguishing between test systems used in healthcare settings and those for use by patients at home will improve product safety and effectiveness of the devices.

By Susan Kelly • Nov. 30, 2018

Canada vows to strengthen device regulation following media probe

More stringent approval requirements and the mandatory publication of clinical data are among the changes being discussed.

By Nick Paul Taylor • Nov. 30, 2018

HHS outlines broad plan to reduce EHR burden

The 74-page draft strategy, required by the 21st Century Cures Act, focuses on reducing time and effort tied to regulatory reporting requirements and increasing functionality and user-friendliness of EHRs.

By Meg Bryant • Nov. 29, 2018

Why political contributions linked to a little-known hearing aid firm topped medtech giants

Spending connected to Starkey Hearing Technologies surpassed Medtronic, Boston Scientific and Edwards Lifesciences during the 2018 election cycle.

By David Lim • Nov. 29, 2018

5 takeaways amid new scrutiny of FDA medical device oversight

A slate of recent agency actions have paralleled a new investigative series on product safety by the International Consortium of Investigative Journalists. Here are five areas that could be impacted.

By David Lim • Nov. 27, 2018

FDA approves autoinjector version of Genentech's Actemra

The Roche unit is pitching the device as a convenient self-administration option for some users of its blockbuster drug.

By Nick Paul Taylor • Nov. 27, 2018

FDA pitches boosting 510(k) scrutiny, asks Congress for help

The agency wants to move away from device maker reliance on 510(k) predicate devices older than 10 years and gain new authority to quickly impose special controls.

By David Lim • Nov. 26, 2018