Medical Devices: Page 137
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CDC/Alissa Eckert, MS. "covid-19 coronavirus on black background". Retrieved from https://www.cdc.gov/media/subtopic/images.htm.
$8.3B in coronavirus funding set in motion as federal agencies ramp up response
The House and Senate passed a bill with allocations for medical supplies and testing as Vice President Mike Pence met with clinical lab execs Wednesday from LabCorp, Quest Diagnostics, Thermo Fisher and others.
By Shannon Muchmore • Updated March 5, 2020 -
Axonics execs bullish on breaking Medtronic market stranglehold
The medtech contends its rechargeable sacral neuromodulation device is making quicker headway in the marketplace than anticipated as it takes on the incumbent.
By Nick Paul Taylor • March 5, 2020 -
Explore the Trendlineâž”
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 -
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 -
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 -
Element Science raises $146M to fund rival to Zoll's wearable LifeVest
Deerfield Healthcare and Qiming Venture Partners USA led the round, joining investors Third Rock Ventures and Google Ventures​ to bring to market Element's wearable defibrillator.
By Nick Paul Taylor • March 4, 2020 -
Hospitals face worries of supply, staff shortages as coronavirus cases tick up
FDA granted a CDC request late Monday for an emergency use authorization that will allow respirators typically used in industrial settings, including N95 masks, to be used in healthcare facilities during the outbreak.
By Shannon Muchmore • March 3, 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 -
Jacob Bell/MedTech Dive
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 -
Insulet pauses automated dosing system trial amid software glitch
The delay will likely push back a U.S. product launch of the diabetes technology until early 2021. Also Monday, competitor Tandem said it won its second FDA designation for an interoperable automated glycemic controller.
By Maria Rachal • 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 -
LivaNova loops Verily into depression device study
A clinical trial meant to support CMS coverage of the U.K. medtech's vagus nerve stimulation system will incorporate a wearable device and phone app from Alphabet's life sciences research organization.
By Maria Rachal • Feb. 27, 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 -
Psychiatrists plan transcranial magnetic stimulation buys: Wall Street report
A survey by investment firm William Blair suggests potential momentum for manufacturers of the noninvasive depression treatment devices, including BrainsWay and its faltering rival Neuronetics.
By Nick Paul Taylor • 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 -
Wright Medical misses Q4 targets as Cartiva shortfall persists
In its annual report, the Stryker target said revenues from its 2018 acquisition of the synthetic cartilage implant maker totaled $25.7 million, compared to the $47 million it had hoped for at the start of the year.
By Maria Rachal • 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 -
Analysis casts doubt on Boston Scientific TAVR embolic protection device
The JAMA Internal Medicine research rekindles debate over whether the device, designed to catch dislodged plaque debris in the carotid arteries before it reaches the brain, is truly effective.
By Susan Kelly • Updated Feb. 25, 2020 -
Tandem shapes FDA strategy for new insulin pump features
Fourth quarter revenues grew 42%, roughly in line with Wall Street's expectations. Shares were down 7% in late morning trading.
By Maria Rachal • Feb. 25, 2020 -
FDA taps breakthrough device meant to prevent opioid overdose deaths
A small Scottish medtech won the fast-track designation for a biosensor that identifies potentially fatal opioid-induced respiratory depression and notifies first responders to administer naloxone.
By Maria Rachal • Feb. 24, 2020
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