FDA posts trio of medical device warning letters

An apparent flurry of enforcement activity disclosed this week comes shortly after the agency signaled a return to greater vigilance following a nearly 90% decline in device-related warning letters from 2015 to 2019.

By Nick Paul Taylor • Feb. 28, 2020

Joint FDA, industry real-world evidence center issues research frameworks

As real-world evidence gains momentum as a tool for assessing medical device safety and effectiveness, NESTcc is laying out guiding principles on research methods and ensuring data quality.

By Amritpal Sandhu-Longoria • Feb. 27, 2020

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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

FDA pilots new 510(k) submission template for device manufacturers

The voluntary assessment will enroll up to nine participants that reflect the makeup of the medical device industry.

By Nick Paul Taylor • Feb. 27, 2020

FDA advises boxed warning for surgical devices half-decade after flagging cancer risk to women

In 2014, FDA warned against the use of laparoscopic power morcellators for hysterectomy or fibroid removal for most women, after determining through its own data analysis that the devices could spread cancerous tissue. 

By Susan Kelly • Feb. 26, 2020

HHS officials warn of medical supply shortages amid coronavirus outbreak

"This is an unprecedented potential severe health challenge globally, and will require additional measures," HHS Secretary Alex Azar told lawmakers in a pitch for $2.5 billion in funding.

By Amritpal Sandhu-Longoria • Feb. 26, 2020

LivaNova gets nod for heater-cooler device changes to cut contamination risk

At the same time, FDA updated its safety guidance for healthcare providers to reduce infection risk during open heart surgery.

By Nick Paul Taylor • Feb. 26, 2020

FDA bolsters CLIA waiver application recommendations

The agency added new sections on failure alerts, labeling and safeguards, doubling the length of a guidance text for in vitro diagnostic manufacturers in the process. 

By Nick Paul Taylor • Feb. 26, 2020

On FDA's agenda: ortho reclassifications, cancer tests, AI in imaging

The agency scheduled an orthopaedic devices advisory panel for April to consider down-classing noninvasive bone growth stimulation systems. On Tuesday, a meeting on artificial intelligence in radiological imaging kicks off.

By Susan Kelly • Feb. 24, 2020

CMS pitches expanding bundled payments for joint replacements

Regulators want to include outpatient hip and knee replacements now that the procedures are off the inpatient-only list. Post-acute care providers may face more financial risk than device makers, some analysts believe.

By Ron Shinkman • Feb. 21, 2020

Cardiovalve gets FDA breakthrough status for tricuspid valve replacement system

The startup, spun out during Edwards' 2017 acquisition of Valtech Cardio, also received U.S. approval to run an early study of its transcatheter system targeting tricuspid regurgitation.

By Nick Paul Taylor • Feb. 21, 2020

DHS warns of WannaCry-like vulnerability in Spacelabs Healthcare systems

The homeland security agency revealed certain telemetry devices suffer from the weakness, scoring 9.8 out of 10 on a cybersecurity vulnerability scale.  

By Nick Paul Taylor • Feb. 19, 2020

FDA tracks uptick in masks, other protective gear in coronavirus update

Commissioner Stephen Hahn said the shift in ordering patterns is yet to manifest in a shortage but warned Friday the situation is “evolving and very dynamic.”

By Nick Paul Taylor • Feb. 18, 2020

AdvaMed, state AGs weigh in ahead of EPA sterilization rule

About a year after FDA told the medical device industry the closure of an Illinois ethylene oxide facility could disrupt supply chains, environmental regulators are considering changes that could affect sterilizers across the country.

By Maria Rachal • Feb. 14, 2020

FDA folds Cook Medical asks into final peripheral vascular atherectomy device 510(k) guidance

The agency made some changes to advice on premarket submissions for technologies used to help remove plaque from diseased arteries.

By Nick Paul Taylor • Feb. 13, 2020

FDA OKs 'Inside-Out' device for enabling hemodialysis in hard-to-treat patients

Bluegrass Vascular Technologies plans to make its De Novo-winning venous access device available at select U.S. sites in the coming months, adding to the revenue it already generates in the EU, Canada and other markets.

By Nick Paul Taylor • Feb. 12, 2020

Emergency use coronavirus tests shows glitches at state level, CDC says

CDC officials said Wednesday that some of the test kits it distributed to states produced inconclusive results when tested independently. The agency noted the tests were not run on patients.

By Maria Rachal • Updated Feb. 13, 2020

Brexit happened. EU MDR looms. 3 key questions on medtech's future in Europe

The U.K. can skip the new in vitro diagnostic rules entirely, and in theory, could unilaterally stop applying MDR after the transition period ends. Both scenarios seem unlikely.

By Nick Paul Taylor • Feb. 4, 2020

Medtech in limbo as Brexit arrives

Although the industry has lobbied for the departing member state to implement the Medical Device Regulation and stick closely to EU rules, a minister in the U.K. government said legislative alignment “just ain't happening.”

By Nick Paul Taylor • Feb. 3, 2020

Amid coronavirus outbreak, FDA and industry seek roadmap for emergency diagnostics

Taking lessons from the Ebola and Zika crises, regulators and manufacturers are meeting Monday to discuss how real-world data could be used to advance more emergency-use diagnostics to full marketing status.

By Maria Rachal • Updated Jan. 31, 2020

UK moves to mitigate impact of notified body withdrawals

Several firms pulled their services amid uncertainty about the impact of Brexit, bringing risks into focus.

By Nick Paul Taylor • Jan. 30, 2020

Privacy versus access debate rages on, rekindled by Epic lobbying

Promoting interoperability without clear guardrails could lead to healthcare's version of Cambridge Analytica, Epic wrote in a public statement coinciding with ONC's annual health IT conference.

By Rebecca Pifer • Jan. 29, 2020

Backing for unique patient identifier picks up steam at ONC conference

A ban on funding UPIs is "misguided policy," Rep. Bill Foster, D-Ill., said Monday at the gathering of IT officials and industry. But other experts warned it's "not a panacea."

By Rebecca Pifer • Jan. 28, 2020

CMS widens NGS test coverage for inherited breast, ovarian cancers

The national decision on next generation sequencing tests doesn't go beyond breast and ovarian cancers, but local Medicare contractors are allowed discretion on coverage determinations with other germline cancer diagnoses.

By Maria Rachal • Jan. 28, 2020

FDA offers 510(k) advice for arthroscopy pump tubing to prevent cross-patient infections

In a draft guidance on the irrigation tubing used across minimally invasive joint procedures, the regulator said without proper design, testing and risk mitigation, backflow of patient fluid can present risk for disease transmission.

By Maria Rachal • Jan. 27, 2020

3 more notified bodies coming soon, EC says as MDR clock ticks down

New designations would move the Commission a step closer to its goal of having 20 notified bodies in place by the end of the first quarter of 2020.

By Nick Paul Taylor • Jan. 23, 2020