J&J, Medtronic, Boston Scientific gird for battle over US cardiac ablation market with new trials

Medtech firms are sharing clinical trial results on pulse ablation devices, which they claim are safer and more effective at halting arrhythmias than current methods.

By Elise Reuter • Feb. 8, 2023

Trade group pushes back on FDA’s clinical decision support guidance

The Clinical Decision Support Coalition is asking the agency to rescind its guidance and propose new rules that change how software tools are regulated as medical devices. 

By Elise Reuter • Feb. 8, 2023

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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

Onshoring, easing labor market expected to drive double-digit growth at US medtech CDMOs

The report identifies revised rules on ethylene oxide as a trend to watch, noting that new requirements for sterilization could “[clear] the way for structural changes in the industry.”

By Nick Paul Taylor • Feb. 8, 2023

UK health system, under strain, lays out medtech strategy

The state-run National Health Service, now facing a strike by nurses and paramedics, hopes new technologies will help solve some of its long-term challenges to improve patient care.

By Susan Kelly • Feb. 7, 2023

Abbott device approval sets up battle with Medtronic, Nevro for diabetic peripheral neuropathy treatment

Three firms are bringing their devices to a $3 billion to $5 billion market, aiming to relieve a painful side effect of diabetes.

By Elise Reuter • Feb. 6, 2023

Medtech earnings highlights: Easing of macro pressures, accelerated growth in 2023

Still, the latest round of quarterly results show that hospital staffing and supply chain remain a challenge.

By Nick Paul Taylor • Feb. 6, 2023

Sensor-loaded, $1 smart glove being tested to reduce stillbirths, maternal deaths

The researchers plan to run clinical trials to show if the device can provide an early warning system for physical impediments to birth.

By Nick Paul Taylor • Feb. 6, 2023

Zimmer Biomet Q4 net loss widens on supply problems; CEO targets acquisitions

The company plans to enter higher-growth markets, even outside of orthopedics, in a bid to increase revenue.

By Elise Reuter • Feb. 3, 2023

Invacare files for Chapter 11 bankruptcy protection amid supply chain woes

The wheelchair maker said it has reached a restructuring agreement with most of its debt holders and that demand for its products remains strong.

By Susan Kelly • Updated Feb. 3, 2023

BD raises full-year forecast, sees Q1 strength in pharmacy automation, pre-fillables

The company’s base businesses helped cushion the impact of declining COVID-19 testing demand.

By Susan Kelly • Feb. 2, 2023

Siemens Healthineers forecasts revenue growth to accelerate despite supply chain woes

Lower diagnostics revenue hurt sales in the three months ended Dec. 31.

By Nick Paul Taylor • Feb. 2, 2023

Vortex ultrasound accelerates brain blood clot clearance in early stage tests

When the ultrasound was formed into a vortex, it cleared more blood clots more quickly than other methods, opening a potential pathway for treatment of cerebral venous sinus thrombosis.

By Nick Paul Taylor • Feb. 2, 2023

Boston Scientific gets Q4 boost from heart, urology sales

Following a series of significant acquisitions, the company said it expects net sales growth of about 5% to 7% in full-year 2023.

By Susan Kelly • Feb. 1, 2023

Edwards posts Q4 profit, reaffirms 2023 outlook as patients return

The heart valve specialist said it is optimistic that the healthcare environment will gradually improve this year.

By Susan Kelly • Feb. 1, 2023

CFO survey hints at funding shift from robots to wearables

The poll from accounting firm BDO found the cost and regulatory hurdles of developing robotics devices are often too high, and lower-cost, less-regulated wearables offer better returns.

By Susan Kelly • Feb. 1, 2023

Stryker expects 2023 growth despite 15% dip in Q4 net income

CEO Kevin Lobo said he expects new product launches and device orders will offset continued “macroeconomic volatility.”

By Elise Reuter • Feb. 1, 2023

Medtech M&A outlook for 2023: Spinoffs, China exits, AI opportunities poised to spur deal rebound

Companies flush with cash are looking for good investments and innovative products that can reduce procedure costs, industry observers say.

By Peter Green • Jan. 31, 2023

FDA device center’s 2022 report reveals 37% drop in annual breakthrough designations

The annual report also highlighted the CDRH’s work on pulse oximeters, Philips’ recall of sleep and respiratory devices, cybersecurity and artificial intelligence.

By Nick Paul Taylor • Jan. 31, 2023

Medtronic recalls 22,000 hemodialysis catheters for potential hub defect

The FDA reported two injuries tied to the problem, which could cause leaks across the tubes of the implanted catheters and produce blood clots.

By Susan Kelly • Jan. 30, 2023

LivaNova recalls circulatory support device for software fix

The update is intended to fix a malfunction that could cause its LifeSPARC pump to stop working. 

By Elise Reuter • Jan. 30, 2023

GE HealthCare posts revenue growth in last quarter before spinoff on imaging, ultrasound units

The company benefitted from “robust end-market demand, improved pricing, and easing supply chain pressures” in the period.

By Peter Green • Jan. 30, 2023

Philips will cut 6,000 more jobs to reduce costs after company swung to net loss in Q4

New CEO Roy Jakobs said Philips has been spreading its resources too thinly and “can't and won't be selling everything everywhere anymore.”

By Nick Paul Taylor • Jan. 30, 2023

Friday Q&A: Tandem’s chief strategy officer talks tubeless pumps, Type 2 plans

Elizabeth Gasser also discusses the company’s recent acquisition of AMF Medical as well as how it factors environmental impact into device design.

By Elise Reuter • Jan. 27, 2023

ResMed quarterly revenue beats estimates as supply chain woes ease

Demand for CPAP devices and respirators remains strong as the company expects to pick up additional market share from rival Philips, and demand grows for its medical SaaS products.

By Susan Kelly • Jan. 27, 2023

Medtronic wearable partner files for bankruptcy but plans to continue ‘without interruption’

Rockley Photonics works with two of the top five medtech companies, plus six leading smart watch makers including Apple, but has run into financial problems.

By Nick Paul Taylor • Jan. 27, 2023