Maryland failed to secure its Medicaid data: OIG

Exploitation could have resulted in unauthorized access to data and disruption of critical operations, but the inspector general did not identify evidence that the system was compromised.

By Susan Kelly • Aug. 15, 2018

AdvaMed pushes back against FDA humanitarian device guidance

The trade group thinks the guidance will deter development of devices to treat rare conditions.

By Nick Paul Taylor • Aug. 15, 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 approves one-year contraceptive ring

The product, developed by the nonprofit Population Council, will be made available in the U.S. through a license agreement with women's health company TherapeuticsMD.

By Susan Kelly • Aug. 14, 2018

Verma touts interoperability, corporate partnerships at Blue Button 2.0 conference

Microsoft, Google and Amazon pledged at the event they are committed "to removing barriers for the adoption of technologies for healthcare interoperability, particularly those that are enabled through the cloud and AI."

By David Lim • Aug. 14, 2018

FDA sets out vision to use real-world data in product evaluations

The agency wants insights into safety and efficacy outside of controlled research environments.

By Nick Paul Taylor • Aug. 14, 2018

Medical device industry caught in US-China trade war

"If this keeps escalating … a tit-for-tat game without any end in sight, that's very concerning to our industry and ultimately to patient care," a top industry imaging official said.

By Meg Bryant • Aug. 13, 2018

Most recalled foot, ankle devices are 501(k) approved, study finds

The less-demanding 510(k) process "may cause the devices to carry a greater risk to patients" due to a lack of clinical data, researchers said.

By Susan Kelly • Aug. 13, 2018

FDA OKs marketing of contraceptive app

The Natural Cycles app has generated controversy in Europe, where women have reported unplanned pregnancies while using it.

By Susan Kelly • Aug. 13, 2018

Burn treatment earns expanded compassionate use approval

The suspension offers a way to achieve permanent closure in burns and other wounds while reducing the amount of skin harvested at the time of surgery.

By Susan Kelly • Aug. 10, 2018

TGA seeks industry input on cybersecurity, medtech software guidance

The agency has commissioned reports to inform approaches that support companies and protect patients.

By Nick Paul Taylor • Aug. 10, 2018

FDA warns overreliance on membrane tests could up fetal death risk

The rupture test results could be misinterpreted, leading to serious adverse events.

By Nick Paul Taylor • Aug. 9, 2018

UnityPoint's second data breach this year could prompt expanded lawsuit

The Des Moines-based nonprofit notified 1.4 million people last week that a phishing attack may have compromised their information.

By Meg Bryant • Aug. 8, 2018

Regs, patient perceptions threaten to throttle neuromodulation growth

Analysts think electrical stimulation devices may struggle to fulfill their commercial potential, challenging the perception that they will soon address a range of unmet neurological medical needs.

By Nick Paul Taylor • Aug. 8, 2018

CMS' Verma stands firm on 2015 EHR deadline, move to open APIs

Meanwhile, the coalition Health IT Now sent a letter to ONC chiding the government for failing to implement information blocking provisions of the 21st Century Cures Act.

By Meg Bryant • Aug. 7, 2018

UK regulators reassure medtech sector about Brexit impact

The MHRA expects little to change until 2021 but the risk of significant near-term upheaval remains.

By Nick Paul Taylor • Aug. 7, 2018

FCC seeks comments on $100M telehealth pilot

The commission noted many low-income consumers, especially in rural areas, lack access to affordable or adequate broadband.

By Susan Kelly • Aug. 6, 2018

NIST offers 'how to' for securing EHRs on mobile devices

Such devices are ubiquitous in healthcare, raising concerns about security and privacy of personal health information.

By Meg Bryant • Aug. 3, 2018

Abbott device to treat Parkinson's now MRI-compatible

Medtronic's deep brain stimulation system was approved in 2002 to treat advanced Parkinson's disease. Abbott acquired its system through its purchase of St. Jude.

By Susan Kelly • Aug. 3, 2018

CMS clears payment for Boston Scientific's newly bought Sentinel

The ruling by the agency was a reversal from an earlier draft and came the day BSX closed its buy of Claret Medical, which makes the device.

By Kerry Dooley Young • Aug. 3, 2018

Industry urges Congress to ease clinical lab pay cuts

The medical device and hospital industries are among those arguing that under the first six months of new reimbursement rates, labs have cut staff, resulting in limited or ended home care visits for homebound patients.

By David Lim • Aug. 3, 2018

EMA faces higher staff losses ahead of move to Amsterdam

The regulator is putting business continuity plans in place, as it expects to lose up to a third of its workforce.

By Suzanne Elvidge • Aug. 2, 2018

Baxter gets CE mark for Evo IQ smart infusion pump

The clearance marks the start of a series of planned regulatory submissions for the device, which will potentially compete with those made by rivals B. Braun and BD.

By Nick Paul Taylor • Aug. 2, 2018

FDA approves Medtronic implant for rare form of hypertension

United Therapeutics will lead commercial promotion of the system, which delivers the drug Remodulin.

By Susan Kelly • Aug. 1, 2018

Industry balks at FDA's cybersecurity plans

"We already know that FDA will reject premarket submissions if they do not follow the cybersecurity guidance," AdvaMed's Zach Rothstein said.

By Meg Bryant • Aug. 1, 2018

Patients often choose higher-cost locations for MRIs, study finds

Referring physicians have more influence over a patient's decision than out-of-pocket costs, according to the report from the National Bureau of Economic Research.

By Les Masterson • July 31, 2018