Medical Devices: Page 127
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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 -
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TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
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 -
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
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