Medical Devices: Page 58
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‘Tripledemic’ concerns spur FDA to issue emergency authorization for flu-COVID-19 combination test
Experts have warned “a viral hurricane is making landfall” as cases of RSV, influenza and COVID-19 rise simultaneously.
By Nick Paul Taylor • Nov. 23, 2022 -
Philips respirator recall reaches 260 reported deaths, FDA says
The agency has received 90,000 medical device reports related to foam problems with Philips’ recalled sleep apnea devices and ventilators.
By Elise Reuter • Updated Nov. 23, 2022 -
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 -
Medtronic lowers full-year forecast, citing drop in procedure growth
A slower-than-expected recovery in certain procedures, including TAVR and spinal cord stimulation, curbed quarterly profit and revenue.
By Elise Reuter • Nov. 22, 2022 -
State AGs urge Apple to protect consumers’ reproductive health data
Apps holding sensitive health data should be required to delete nonessential information and clearly inform consumers what information they share with parties such as law enforcement, the 10 state attorneys general said.
By Rebecca Pifer • Nov. 22, 2022 -
Zimmer lands 510(k) clearance for 3D-printed cementless knee replacement
The new joint uses anatomical data in combination with 3D printing to try to directly mimic the architecture of human spongy bone.
By Nick Paul Taylor • Nov. 22, 2022 -
Apple earbuds show promise as hearing aids in clinical trial
The earbuds performed comparably to hearing aids in terms of speech perception in quiet environments.
By Nick Paul Taylor • Nov. 22, 2022 -
Q3 Earnings Wrap: Bumpy time for medtech with inflation, FX, supply woes
Macroeconomic pressures were a persistent theme for the industry, with workforce reductions a part of the fallout for some companies.
By Susan Kelly • Nov. 21, 2022 -
Apple Watch app for monitoring Parkinson’s symptoms earns FDA clearance
The technology has been validated in a clinical trial, positioning h2o to create an app that enables real-time sharing of Parkinson’s symptom data.
By Nick Paul Taylor • Nov. 21, 2022 -
How wearable devices with skin-like stretchability may pave way for better health tracking
An AI-enabled prototype based on the stretchable technology was more than 95% effective at correctly identifying electrocardiogram signals.
By Nick Paul Taylor • Nov. 21, 2022 -
Q&A
Friday Q&A: Embecta CEO talks BD spinoff, future of diabetes devices
Dev Kurdikar spoke with MedTech Dive about developing an insulin pump for patients with Type 2 diabetes and what’s next for the firm.
By Elise Reuter • Nov. 18, 2022 -
AdvaMed pushes Biden to use $52B chip program to support medtech supply chains
The group wants agencies to coordinate with the medtech industry to ensure investments are directed toward “technologies that power medical devices.”
By Nick Paul Taylor • Nov. 18, 2022 -
Philips’ ventilator woes grow as FDA issues alert over replacement foam
Replacement noise reduction material in Trilogy ventilators can block the air inlet and let trace amounts of particulate matter into the air pathway.
By Nick Paul Taylor • Nov. 18, 2022 -
Medtronic’s renal denervation treatment ‘still a viable therapy’ despite study miss, doctors say
While the study missed its primary endpoint, the surgery likely will be an option for patients with drug-resistant hypertension.
By Elise Reuter • Nov. 17, 2022 -
Insulet warns Omnipod 5 insulin pump charge issue may cause fire
Rapid sales growth at the company has come amid safety problems involving some of its devices.
By Nick Paul Taylor • Nov. 17, 2022 -
Medtronic doubles wear time of insulin pump infusion sets
The company calculated users of its extended-wear system will change their devices 75 fewer times, resulting in annual savings of more than $1,000.
By Nick Paul Taylor • Nov. 16, 2022 -
Penumbra expands VR rehabilitation platform with lower body sensors
Adding lower body sensors will enable the company to target a wider range of health conditions.
By Nick Paul Taylor • Nov. 16, 2022 -
NFL expands program to use sensor-loaded mouthguards to gather head impact data
Data from the sensors could show what the human head experiences during an impact, improving efforts to reduce the incidence of concussions in football.
By Nick Paul Taylor • Nov. 15, 2022 -
Illumina cuts workforce by 5% amid supply chain woes, sales slowdown
The layoffs come as the firm wrestles with flat growth and a possible forced divestiture of its GRAIL cancer-detection unit.
By Nick Paul Taylor • Nov. 15, 2022 -
HHS cybersecurity center warns of new ransomware threat
Venus ransomware has attacked targets worldwide, including at least one U.S. health group, since it was first identified in mid-August.
By Susan Kelly • Nov. 14, 2022 -
Tandem pump, paired with Dexcom CGM, boosts blood glucose control in Type 2 diabetics
Patients with Type 2 diabetes spent 3.6 hours per day longer in the target blood glucose range after switching to Tandem’s system, a study found.
By Nick Paul Taylor • Nov. 14, 2022 -
Mayo Clinic creates product to test AI models for bias and inaccuracy
The proliferation of AI models has led to concerns about whether they work as intended.
By Nick Paul Taylor • Nov. 14, 2022 -
Green light shows promise in addressing oximetry racial bias: study
Researchers created a noninvasive device that performed comparably to Abbott’s invasive i-STAT in a small clinical trial.
By Nick Paul Taylor • Nov. 14, 2022 -
GE HealthCare prices offering of $8.25B in bonds as part of spinoff
The GE unit is stepping up its preparations to operate as an independent company.
By Nick Paul Taylor • Nov. 11, 2022 -
BD says inflationary pressures persist; COVID-19 test sales plunge
Revenue at the company’s medical segment grew in the fourth quarter, helped by the acquisition of pharmacy automation company Parata.
By Elise Reuter • Nov. 10, 2022 -
Medtech execs ‘rethink’ long-term strategies as care settings shift: Accenture report
The move from hospitals to ambulatory and at-home care is only just beginning, the survey found.
By Nick Paul Taylor • Nov. 10, 2022