FDA: Page 68
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UK looks to use Brexit to make device industry more transparent
The House of Commons bill seeks to address a regulatory gap for medical devices, as the previous legal framework is based on EU directives. One element provides new information-sharing powers related to safety.
By Nick Paul Taylor • March 5, 2020 -
Some pacemakers, EKGs, diabetes devices may face newly flagged Bluetooth cyber risk
FDA and the Department of Homeland Security said microchips from seven manufacturers and a range of consumer wearables and connected medical devices may be affected.
By Susan Kelly • March 4, 2020 -
Explore the Trendlineâž”
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TrendlineMedical 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 bans certain electrical stimulation devices called 'barbaric'
Amid mounting pressure from lawmakers, the agency handed down its third-ever medical device ban, finalizing a 2016 proposal prohibiting current and future sale of certain devices to treat self-injury or aggressive behavior.
By Maria Rachal • March 4, 2020 -
E.A. Crunden/MedTech Dive
AdvaMed, Medtronic among top 20 pharma and health product lobbyists over 2 decades: study
The medical devices trade association spent $79.4 million on lobbying from 1999 to 2018, making it the fifteenth biggest spender.
By Nick Paul Taylor • March 3, 2020 -
Olympus-backed Medi-Tate gets FDA nod for prostate device
The Japanese corporation has an option to buy the Israeli startup and its newly De Novo-authorized benign prostatic hyperplasia device.
By Nick Paul Taylor • March 3, 2020 -
Supreme Court to again decide fate of ACA
The high court said Monday it would hear the case that seeks to overturn the Affordable Care Act pushed by Texas and other red-leaning states.
By Samantha Liss • Updated March 2, 2020 -
FDA seeks 'right balance' as it permits immediate use of coronavirus tests
"We are not changing our standards for issuing Emergency Use Authorizations," Commissioner Stephen Hahn said Saturday as the agency issued new guidance aimed at accelerating testing capacity in the U.S.
By Susan Kelly • March 2, 2020 -
Courtesy of Centers for Disease Control and Prevention
Coronavirus: No US shortages of essential devices yet, as FDA monitors more than 60 companies
Still, manufacturers operating 72 plants in China face workforce pressures and surging demand for some equipment, FDA said in an update late Thursday.
By Nick Paul Taylor • Feb. 28, 2020 -
California's new cybersecurity law sidesteps most medical devices, lawyers say
How the state enforces its "internet of things" or connected devices law "may end up becoming a source of persuasive authority for the FDA in its decision making" on cybersecurity guidance, said White and Williams' Joshua Mooney.
By Fred Donovan • Feb. 28, 2020 -
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 -
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 -
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 -
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
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