FDA issues draft guidance on blood glucose monitors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

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

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

Beckman initiates Class I recall of flow cytometers

FDA is concerned inaccurate results provided by the devices could lead to serious injuries or deaths.

By Nick Paul Taylor • Nov. 22, 2018

FDA device inspections hit high amid overseas oversight push

The agency conducted 2,952 inspections of medical device manufacturers last year, an increase of 46% over 2007.

By Nick Paul Taylor • Nov. 22, 2018

ECRI launches clinical guidelines site to replace resource HHS shuttered

The new portal will include "expertly vetted, evidence-based guideline briefs and scorecards" for the healthcare community, according to the Pennsylvania-based nonprofit group.

By Rebecca Pifer • Nov. 21, 2018

FDA details ramp-up of postmarket device oversight

The agency laid out plans to increase postmarket surveillance of medical devices and previewed details coming next week on how it expects to modernize premarket reviews, especially the 510(k) process.

By Susan Kelly • Nov. 21, 2018

Telehealth laws inhibit widespread use in Medicare population, CMS says

The agency is taking steps to open up virtual care options in some alternative payment models, but use among fee-for-service beneficiaries is only 0.25%, according to a new report.

By Meg Bryant • Nov. 19, 2018

Abbott seeks clearer security standards as feds increase cyber risk focus

President Trump is expected to sign legislation Friday creating a new cyber agency within the Department of Homeland Security. 

By Maria Rachal • Nov. 16, 2018

CMS' Verma outlines vision for connected digital health network

The agency also submitted a report to Congress on the state of Medicare telehealth, outlining how beneficiaries are currently using remote care and how CMS is looking to further expand similar services to rural areas.

By Nick Paul Taylor • Nov. 16, 2018

House chairman sees 'every indication' that VA's EHR difficulties will continue

"Frankly," Indiana Rep. Jim Banks said, "the more I learn about the EHR program, the more daunting it has become." 

By Tony Abraham • Nov. 15, 2018

AdvaMed makes lame duck push for medical device tax repeal

Given the impending Democratic control of the House, the trade group's CEO Scott Whitaker said "the chances are not as great next year" for permanent repeal if the industry does not garner a victory.

By David Lim • Nov. 15, 2018

FDA sounds alarm about off-label drug use in pain pumps

The agency wants physicians to stick to approved drugs to reduce the risk of device failure in the pumps, which include those sold by Medtronic and J&J.

By Nick Paul Taylor • Nov. 15, 2018

US Vascular gets FDA warning letter for long-running problems

Most of the points raised in the regulatory notice date back to a 2016 inspection.

By Nick Paul Taylor • Nov. 15, 2018

FDA plans to waive informed consent for some clinical trials

The change would enable sponsors to run certain minimal-risk studies without gaining consent from participants. FDA said Friday it will reopen the comment period on the proposed rule.

By Nick Paul Taylor • Updated Feb. 22, 2019

Medtronic gets CE mark for low-profile thoracic endograft

The clearance comes weeks after FDA approved the Valiant Navion TEVAR endograft.

By Nick Paul Taylor • Nov. 14, 2018

It's final: Amazon pegs NY, Virginia for HQ2 (with a nod to Nashville)

Amazon will split its new North American headquarters over two sites. The city of Nashville is also a surprise winner, landing 5,000 jobs as part of an "operations center of excellence," the company said Tuesday.

By Samantha Liss • Nov. 13, 2018

Grassley questions FDA about 'troubling' cybersecurity audit

"Medical devices could be exploited by those same foreign actors to not only interfere with normal device operation, which could cause harm to patients, but also to steal personal medical information," the senator wrote.

By Nick Paul Taylor • Nov. 13, 2018

3D printing poised to disrupt healthcare

Health industry types are "100% convinced, and rightly so, that [3D printing] will be a core part of their business in five to 10 years," ISG's Michael Harmon said.

By Meg Bryant • Nov. 12, 2018

FDA clears battery-powered Ebola test for emergency use

The regulatory decision adds to the testing capabilities of public health clinics and treatment centers.

By Nick Paul Taylor • Nov. 12, 2018

Monteris modifies brain ablation device to counter safety risk

FDA cleared a new model that features a fiber optic probe designed to stop the original heating problem.

By Nick Paul Taylor • Nov. 9, 2018