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

Explore the Trendline➔

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

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

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

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

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

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

Battle of the 'bots: 4 robotic surgery rivalries to watch in the year ahead

Two decades after FDA cleared Intuitive's da Vinci for general surgery, a crowded field of medtechs looks to expand the reach of robots in bronchoscopy, bariatric surgery, joint replacements and more.

By Susan Kelly • Feb. 24, 2020

Dexcom makes inroad in pregnant population with CE mark for CGM

Real-world evidence and other research helped the company secure a CE mark, CEO Kevin Sayer told MedTech Dive on Thursday, calling it "a first step toward a very big market for us."

By Maria Rachal • 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