FDA adds information on device BLAs to user fee guidance

The revised document features additional information on the fees for device biologics license applications.

By Nick Paul Taylor • Dec. 13, 2018

FDA rates GE ventilator safety guard recall as Class I event

The recall was triggered after the tech giant discovered the device has the potential to disconnect from the patient's breathing circuit.

By Nick Paul Taylor • Dec. 13, 2018

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Apple EKG, artificial iris among FDA 2018 device decisions

De Novos are on the rise, but both premarket approvals and 510(k)s appear to be slightly down from 2017, according to nearly year-end data from FDA.

By Meg Bryant • Dec. 12, 2018

Australia plans reclassification of medical software to better reflect risk

The country's regulator thinks the current system underestimates the threat posed by software as a medical device.

By Nick Paul Taylor • Dec. 12, 2018

Lawmakers impatient for ONC interoperability rule

"It is hard to explain to people that Congress provided the tools necessary for doctors and patients to better coordinate their care through the sharing of patient data, but nothing has changed," Rep. Michael Burgess, R-Texas, said at a House health subcommittee hearing.

By Rebecca Pifer • Dec. 11, 2018

Thermo Fisher gets FDA nod for plazomicin immunoassay

The antibiotic, marketed as Zemdri, is used to treat patients with complicated urinary tract infections.

By Susan Kelly • Dec. 11, 2018

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

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