Medical Devices: Page 55
-
Getty Images
Trade groups urge CMS to expand, quickly finalize breakthrough device pathway
The groups want changes that include expanding the program to cover breakthrough diagnostics and previously authorized products.
By Nick Paul Taylor • Aug. 30, 2023 -
Getty Images
GE HealthCare rolls out software to speed assessment of AFib patients
The program aims to cut the time physicians spend searching multiple systems to understand the cardiac history of AFib patients.
By Nick Paul Taylor • Aug. 29, 2023 -
Explore the Trendline➔
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 -
Photo by Anna Tarazevich from Pexels
Hopes dim for Medtronic hypertension treatment after FDA panel rebuff
Analysts foresee hurdles to reimbursement even if the device wins the agency’s nod, and some don’t expect approval at all.
By Susan Kelly • Aug. 29, 2023 -
Courtesy of https://news.medtronic.com/Left-Ventricular-Assist-Device-For-Advanced-Heart-Failure#assets_34137_10-122:19299
Medtronic identifies patients at increased risk of heart pump failure
The company has recalled its HeartWare HVAD pump multiple times since it was pulled from the market in 2021.
By Elise Reuter • Aug. 29, 2023 -
Courtesy of 3M.
3M reaches $6B settlement to resolve combat earplug lawsuits
The agreement is much less than the $10 billion forecast by analysts.
By Nick Paul Taylor • Aug. 29, 2023 -
Permission granted by Boston Scientific
Boston Scientific’s pulsed field ablation device matches standard of care in AFib trial
RBC analysts forecast “conversion of 80% to 90% of the market over a 2-3 year period” after seeing the Farapulse data.
By Nick Paul Taylor • Aug. 28, 2023 -
Getty Images
US signs consent decree requiring EPA to finalize ethylene oxide rule by March
A medtech trade group called the deadline inadequate for the EPA to complete the “substantial” work that remains.
By Nick Paul Taylor • Aug. 28, 2023 -
Getty Images
VC funding in medtech ticks up, raising hopes that slump has bottomed
Analysts also forecast renewed interest in M&A now that large companies have worked through a string of spinoffs.
By Nick Paul Taylor • Aug. 25, 2023 -
Permission granted by Cydar Medical
Medtronic’s endovascular artificial intelligence pilot program treats first patient
A physician in the pilot used a 3D map of patient tissue in the image-guided minimally invasive surgery.
By Nick Paul Taylor • Aug. 25, 2023 -
Permission granted by Zimmer Biomet
‘Business as usual’ at Zimmer Biomet despite sudden CEO change
Incoming Chief Executive Ivan Tornos could accelerate the orthopedics company’s turnaround through acquisitions and by expanding its margins, analysts said.
By Elise Reuter • Aug. 24, 2023 -
Permission granted by Medtronic
Medtronic renal denervation device hits setback at FDA panel
The agency’s outside advisers found the risks of the procedure to lower blood pressure outweighed the benefits in a narrow vote.
By Susan Kelly • Aug. 24, 2023 -
Courtesy of Draeger
Draeger’s ventilator sound insulation recall triggers FDA Class I notification
The company found concentrations of a potentially carcinogenic foam component were above acceptable levels for children.
By Nick Paul Taylor • Aug. 24, 2023 -
Courtesy of Recor
Recor wins FDA panel’s backing for high blood pressure device
The advisers found the company’s renal denervation system is safe and effective, but several panelists expressed concern about the long-term durability of the treatment.
By Susan Kelly • Aug. 23, 2023 -
Sean Gallup via Getty Images
Bayer inks deal to commercialize Mahana’s prescription digital therapeutics
The multimillion-dollar distribution and marketing partnership comes amid a decline in funding for prescription digital therapeutic companies.
By Nick Paul Taylor • Aug. 23, 2023 -
Courtesy of Levita Magnetics
Levita’s surgeon-controlled arm for magnetic procedures gains 510(k) clearance
The device maker says the technology can reduce the need for an additional assistant in the operating room, driving efficiency.
By Nick Paul Taylor • Aug. 23, 2023 -
Medtronic raises earnings forecast amid supply chain, diabetes business improvements
The company also shared an update on the planned divestment of its monitoring and respiratory interventions segments.
By Elise Reuter • Aug. 22, 2023 -
Retrieved from Axonics on August 22, 2023
Axonics appoints Kari Keese to CFO post as Dan Dearen retires
The retirement of company co-founder Dearen is “unexpected but not concerning,” Truist analyst Richard Newitter said.
By Susan Kelly • Aug. 22, 2023 -
Courtesy of 3M
Zimmer Biomet CEO Hanson departs for 3M
COO Ivan Tornos will become the orthopedic device maker’s new top executive.
By Elise Reuter • Aug. 22, 2023 -
Getty Images
Bruker to buy PhenomeX and its cell research tools for $108M
The life science tools sector is ripe for consolidation, according to analysts at TD Cowen.
By Susan Kelly • Aug. 18, 2023 -
Courtesy of Dexcom
Deep DiveDexcom, Abbott ramp up DTC marketing amid fight for share of growing diabetes market
As insurers cover continuous glucose monitors for more people, device-makers are taking a page from the pharma marketing playbook.
By Elise Reuter • Aug. 17, 2023 -
Courtesy of Integra
Integra receives warning letter related to quality issues at Boston plant
The company recalled all products made at its Boston facility over the last five years, and hopes to restart manufacturing in the fourth quarter.
By Elise Reuter • Updated Aug. 17, 2023 -
Courtesy of Philips
One death, 2 injuries reported in recall of Philips Trilogy ventilators
Philips warned in a previous recall about problems with the devices’ sensors that can lead to under-delivery of oxygen.
By Elise Reuter • Aug. 16, 2023 -
Retrieved from GE HealthCare via Business Wire.
GE HealthCare wins FDA clearance for wireless hospital vital sign monitor
The Portrait Mobile device is one of GE HealthCare’s “first major introductions in monitoring in recent years,” according to the company.
By Nick Paul Taylor • Aug. 16, 2023 -
Getty Images
Medtronic’s dialysis device recall assigned to Class I by the FDA
The company contacted customers after routine manufacturing testing identified a blockage that could obstruct the catheter.
By Nick Paul Taylor • Aug. 16, 2023 -
Courtesy of Insulet Corp.
Insulet claims EOFlow copied patch-pump design in patent suit
Insulet filed the lawsuit as competitor Medtronic plans to buy EOFlow for $738 million.
By Elise Reuter • Aug. 15, 2023
Previous
