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

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

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

Ortho, spine players Smith & Nephew, NuVasive and Globus post Q4 results

The three rivals posted healthy sales growth, with Smith & Nephew topping $5 billion in revenue for 2019.

By Nick Paul Taylor • Feb. 21, 2020

FDA deems Abbott Vascular, ResMed, Teleflex recalls high risk

Problems with the affected coronary catheters from Abbott and ventilators from ResMed each resulted in one death, the agency reported Wednesday.

By Susan Kelly • Updated Feb. 20, 2020

Teleflex strikes $260M deal, gaining parts used in TAVR procedures

In releasing quarterly results, the Wayne, Pennsylvania-based medtech also gave updates on a new direct-to-consumer ad campaign and headwinds expected from the coronavirus outbreak.

By Nick Paul Taylor • Feb. 20, 2020

Abbott, Dexcom outline plans for CGM compatibility with Insulet's Horizon

As a key diabetes conference gets underway, the dominant glucose monitoring medtechs specified that G6, G7 and FreeStyle Libre 2 users will be able to integrate with the tubeless, smartphone-operated insulin delivery system.

By Maria Rachal • Feb. 19, 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

Senseonics' implantable CGM wins Cigna coverage, shares soar

The diabetes tech manufacturer's stock closed up 24% on the news. CEO Tim Goodnow late last year identified Cigna, along with Anthem and UnitedHealthcare, as key commercial payers to win over.

By Nick Paul Taylor • Feb. 19, 2020

Medtronic misses revenue estimates as TAVR position falters

A disappointing quarter for the medtech giant, with particular softness across pain therapies and cardiac rhythm and heart failure, sent shares down nearly 4% in morning trading Tuesday.

By Maria Rachal • Feb. 18, 2020

As CMS coverage decision nears, Abbott gears for MitraClip expansion

An expanded national coverage determination could accelerate already-strong sales of the device, and the company is planning to add manufacturing capacity and sales reps in anticipation.

By Susan Kelly • Feb. 18, 2020