Red states say 'yes' to Medicaid; DME gets boost in Nevada

Three GOP-heavy states expanded Medicaid on Tuesday, and Democratic governor pickups in other parts of the country could further the trend. Elsewhere, durable medical equipment makers scored a win in Nevada.

By Rebecca Pifer • Nov. 7, 2018

Abbott, J&J take part in FDA's NEST real world evidence pilot

The test cases will assess the role of RWE in proactive post-market surveillance, the evaluation of ablation devices and other activities across the medical device lifecycle.

By Nick Paul Taylor • Nov. 6, 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

Pact to rush medical products for military clinched

The memorandum signed by the FDA and Department of Defense formalizes a program to speed review of high-priority treatments for the military such as freeze-dried plasma.

By Susan Kelly • Nov. 5, 2018

ACLA praises CMS for boosting data collection

The clinical lab trade group lauded the agency for taking steps to increase the number of laboratories submitting data informing Medicare payment rates.

By David Lim • Nov. 5, 2018

Midterms 2018: Key health ballot votes in the states

It's not just Congress up for grabs in Tuesday's midterm elections. From Medicaid expansion to dialysis treatments to nurse staffing ratios, here's a snapshot of key votes, the odds and what they could mean for the industry.

By David Lim , Tony Abraham , Rebecca Pifer , Samantha Liss • Nov. 2, 2018

CMS finalizes DME bidding program overhaul despite cost

Administrator Seema Verma said the final rule will increase patient access to medical products, but an August GAO report found beneficiaries are able to get needed items under the current paradigm.

By David Lim • Nov. 2, 2018

Patient deaths following Getinge device shutdowns prompt FDA warning

The agency has reports of three patient deaths following intra-aortic balloon pump malfunctions.

By Nick Paul Taylor • Nov. 2, 2018

FDA warns about Roche test after reports of patient strokes

Two patients suffered serious injuries involving strokes, prompting a warning that inaccurate results from the Swiss pharma's CoaguChek could cause serious injuries or death when taken with the blood thinner warfarin.

By Nick Paul Taylor • Nov. 2, 2018

Zimmer gets FDA nod for knee implant as portfolio strategy advances

Clearance coincided with first use of the device maker's knee surgery robot. The CEO has been vague about how it will differentiate its knee and spine devices from rival products, such as those sold by Mazor Robotics and Stryker.

By Nick Paul Taylor • Nov. 1, 2018

23andMe wins FDA clearance for first-of-its-kind genetic test

The agency also sent a safety communication warning about the danger of relying on genetic tests that have not been reviewed by FDA making claims about patient response to individual medications.

By David Lim , Nick Paul Taylor • Nov. 1, 2018

A timeline of Anthem's bold payment policies (and the fallout)

The payer's aggressive moves to push procedures like imaging to outpatient settings and taking a hard line on emergency room visits has drawn fire from doctors and other critics.​

By Samantha Liss • Oct. 31, 2018

HHS opens cybersecurity coordination center after troubled year

It comes five months after a bipartisan group of lawmakers took HHS to task over stuttering attempts to coordinate cybersecurity information sharing.

By Nick Paul Taylor • Oct. 31, 2018

AdvaMed pitches new Anti-Kickback Statute safe harbors

The trade group wants the carve-outs for value-based pricing, warranty and risk-sharing arrangements.

By David Lim • Oct. 30, 2018

5 sticking points in the EU medical device reg transition

Brexit and notified body capacity are among the uncertainties, as many in the medtech sector are uninformed.

By Meg Bryant • Oct. 29, 2018

Speedy Medicare breakthrough device coverage plan slated for March

AdvaMed has been pushing the agency to take steps to limit the delay between FDA approval and reimbursement. 

By Nick Paul Taylor • Oct. 26, 2018

Novarad augmented reality system for surgery clears FDA

The OpenSight system is designed for use with Microsoft HoloLens technology.

By Meg Bryant • Oct. 25, 2018

Medtronic's dose-controlling app for pain pump gets FDA nod

The technology enables users to deliver doses on demand to cope with breakthrough pain.

By Nick Paul Taylor • Oct. 25, 2018

FDA clears Ansh Labs menopausal status test

Physicians can use the results to inform actions to prevent osteoporosis and heart disease.

By Nick Paul Taylor • Oct. 25, 2018

Adverse events prompt FDA to advise monitoring of Alcon implants

For now, the FDA says the problem looks to be limited to Alcon's implant. Glaukos markets a rival iStent device and saw its stock price increase by 40% when Alcon withdrew its stent.

By Nick Paul Taylor • Oct. 25, 2018

LabCorp blames data breach, hurricane for substandard Q3

The diagnostics branch was "particularly disappointing," said chairman and CEO Dave King.

By Rebecca Pifer • Oct. 24, 2018

FDA starts 510(k) pilot to cut optical tomography processing times

The program aims to give developers of optical coherence tomography devices the chance to discuss premarket performance testing recommendations with the agency.

By Nick Paul Taylor • Oct. 24, 2018

Medtronic's low-profile thoracic endograft gets FDA nod

By expanding TEVAR to patients with a broader range of anatomies, Medtronic could gain an edge over rivals Bolton Medical, Cook Medical and Gore Medical.

By Nick Paul Taylor • Oct. 24, 2018

Viseon gets 510(k) clearance for spinal surgery device

The product enables visualization of surgical sites during minimally-invasive procedures.

By Nick Paul Taylor • Oct. 19, 2018

FDA sets busy year-end medical device to-do list

Improving mammography quality, revamping the De Novo classification process and revising the definition of a medical device to exclude certain medical software are some of the agency's priorities.

By David Lim • Oct. 19, 2018

Stakeholders call for transparency, ease of use in EHR Reporting Program

In comments, several healthcare organizations requested a centralized clearinghouse of existing health IT comparison resources.

By Meg Bryant • Oct. 18, 2018