FDA: Page 74
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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 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
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 -
Jacob Bell/MedTech Dive
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 -
Retrieved from U.S. Environmental Protection Agency.
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 -
Jacob Bell/MedTech Dive
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 Parduhn • 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 Parduhn • 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 -
Surgical gown recall sets Cardinal back $96M
The company estimates a $96 million second quarter charge related to the recall, amid two new field actions affecting procedure kits with the gowns. Cardinal previously saw red flags with the supplier at the root of the problem.
By Nick Paul Taylor • Updated Jan. 31, 2020 -
HHS price transparency efforts may decode only sliver of total spending
A new analysis focused on non-emergency care that a patient can choose deliberately, such as hip or knee replacements, as opposed to emergency services.
By Ron Shinkman • Jan. 21, 2020 -
Supreme Court declines to quickly hear ACA case
It's unlikely the case will be decided before the election, which will thrust the debate over the fate of the landmark law into the spotlight during another presidential campaign.
By Samantha Liss • Jan. 21, 2020
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