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

Explore the Trendline➔

Top 5 stories from MedTech Dive

From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

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 Parduhn • 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

FDA targets late 2019 for hearing aid proposed rule

The plan comes two weeks after Bose won clearance to sell the first self-fitting hearing aid that can be programmed without the help of a healthcare provider.

By David Lim • Oct. 18, 2018

FDA floats changes to cybersecurity guidance to strengthen safeguards

Proposals include creation of lists of all hardware and software components used in a device that could be vulnerable to attack.

By Nick Paul Taylor • Oct. 18, 2018

FDA boosts medical device cybersecurity coordination with Homeland Security

The DHS Office of Cybersecurity and Communications and FDA's device center will increase information sharing of potential and confirmed device vulnerabilities and threats.

By David Lim • Oct. 16, 2018

Anthem shells out $16M to settle biggest health data breach in history

The fund will pay for four years of credit monitoring and all other claims, costs and fees for affected individuals, according to the settlement. 

By Rebecca Pifer Parduhn • Oct. 16, 2018

Endologix recalls cardiac implants amid ongoing rupture risk

The Class I recall stems from reports of some devices failing to divert blood away from aneurysms.

By Nick Paul Taylor • Oct. 16, 2018

Blue Button 2.0 doubles developers to 1,200, but beneficiary uptake tiny

CMS Administrator Seema Verma tells MedTech Dive that 11 organizations have "production apps" in place using live data.

By David Lim • Oct. 15, 2018

National Academy of Medicine argues barriers to interoperability are organizational, not technical

An extensive report outlining challenges and recommendation for data sharing comes as the industry awaits a rule from HHS that attempts to thwart information blocking.

By Rebecca Pifer Parduhn • Oct. 15, 2018

FDA monitoring 11 device firms for shortages in aftermath of Hurricane Michael

In addition, HHS has moved 400 medical and public health professionals and medical equipment into impacted areas.

By David Lim • Oct. 12, 2018

FDA warns of Medtronic device cybersecurity risk

The alert follows discovery that hackers could adjust the settings of cardiac devices. While the FDA has not received reports of patient harm, Medtronic has disabled the online software update.

By Nick Paul Taylor • Oct. 12, 2018

Congress expands Sunshine payment reporting rules

A bill expected to be signed by the president requires companies report payments to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and certified nurse-midwives.

By Nick Paul Taylor • Oct. 11, 2018

Top Democrats question FDA Pre-Cert program safety, statutory authority

Concern that the agency may be overstepping its authority echoes comments submitted by the Clinical Decision Support Coalition.

By David Lim • Oct. 11, 2018

FDA takes aim at lack of pediatric devices

"Funding is a huge challenge because of the inherently small market," Reed McCarty, co-founder and partner at SandBox Medical, told MedTech Dive.

By Meg Bryant • Oct. 8, 2018

Bose self-fitting hearing aid gets FDA approval

The product is the first to be cleared by the agency that can be purchased and programmed without a doctor's prescription.

By Susan Kelly • Oct. 8, 2018

UK recalls 58K pregnancy tests after false positive reports

The digital displays of some devices erroneously told users they were pregnant.

By Nick Paul Taylor • Oct. 5, 2018

CMS tweaks local coverage policy to speed access to medical devices

AdvaMed CEO Scott Whitaker said that the CMS actions are commendable, but more should be done.

By David Lim • Oct. 4, 2018