BD tells customers not to use Cardinal’s Monoject syringes with Alaris pumps

The FDA labeled BD's safety notice as a Class I event. The warning comes amid several actions from the agency on the safety of syringes.

By Nick Paul Taylor • Dec. 4, 2023

Empatica aims to develop seizure-forecasting algorithm based on wearable data

The company plans a study using its wrist-worn device to capture real-world data that could help understand and predict seizures for people with epilepsy.

By Nick Paul Taylor • Dec. 1, 2023

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

GE HealthCare, Hologic put AI at center of radiology pitches

BTIG analysts said GE HealthCare believes AI can help clinicians and radiologists do their jobs better, which is important due to the “ongoing shortage of radiologists and the high rates of burn out.”

By Nick Paul Taylor • Dec. 1, 2023

Moon Surgical CEO Anne Osdoit on readying a soft tissue robot for launch

With support from J&J’s venture capital arm and chip maker Nvidia, Moon is targeting a soft tissue surgery market dominated by Intuitive Surgical.

By Susan Kelly • Dec. 1, 2023

FDA advises against using plastic syringes made in China amid reports of quality failures

Officials began the investigation after receiving information about quality issues associated with “several Chinese manufacturers of syringes.”

By Nick Paul Taylor • Dec. 1, 2023

J&J heats up LAA closure competition with $400M Laminar buy

Just days after Medtronic announced it would launch a LAA device, J&J said it has acquired a company that is developing a new treatment for LAA closure.

By Susan Kelly • Nov. 30, 2023

Vivos receives FDA 510(k) clearance for oral devices to treat severe sleep apnea

The clearance positions the company to offer an alternative to continuous positive airway pressure devices and neurostimulation implants.

By Nick Paul Taylor • Nov. 30, 2023

GE HealthCare gets 510(k) clearance for algorithm to detect collapsed lungs

The system provides immediate notifications to support the triaging of emergency room patients.

By Nick Paul Taylor • Nov. 29, 2023

3 medtech spinoffs that reshaped the industry in 2023, and what to expect next

GE HealthCare, Johnson & Johnson and Danaher completed transactions this year. Baxter, 3M and Medtronic are now on deck.

By Susan Kelly • Nov. 29, 2023

Advamed applauds Biden’s new actions to strengthen U.S. supply chains

The actions include using the Defense Production Act to enable investment in U.S. manufacturing of essential medicines and medical countermeasures, such as diagnostics.

By Nick Paul Taylor • Nov. 29, 2023

‘Fire, smoke, burns’: FDA warns about new safety risks for Philips CPAP machines

Philips recently filed more than 270 reports of thermal problems related to its DreamStation 2 device from the past three years.

By Elise Reuter • Nov. 28, 2023

Orthofix hires new CEO, 2 months after former leaders ousted

Massimo Calafiore is expected to join the spine and orthopedic device maker in early 2024 from Italy-based LimaCorporate.

By Susan Kelly • Nov. 28, 2023

Unomedical recall of infusion sets tagged as Class I by FDA

The company notified Tandem Diabetes Care, its sole consignee, in October of the risk for infusion sets to detach from insulin pumps, disrupting insulin delivery.

By Nick Paul Taylor • Nov. 28, 2023

Medtronic to chase Boston Scientific, Abbott in left atrial appendage closure market

The medtech giant acquired the Penditure LAA exclusion system in August from Miami-based medical device incubator Syntheon.

By Susan Kelly • Updated Dec. 6, 2023

Roundup: Top medtech companies cut jobs in 2023

Johnson & Johnson, Medtronic and Abbott were among the top companies to announce layoffs this year as the industry implemented cost-cutting measures.

By Ricky Zipp • Nov. 27, 2023

Why medical device companies are worried about the EPA’s planned sterilization regs

The EPA is expected to finalize new regulations in March that would limit ethylene oxide emissions from companies that sterilize medical devices.

By Elise Reuter , Shaun Lucas • Nov. 27, 2023

FDA withdraws from Global Harmonization Working Party

The agency has become “concerned with the divergent harmonization efforts for medical devices” and will focus on working with the International Medical Device Regulators Forum going forward.

By Elise Reuter • Nov. 27, 2023

LivaNova warns cybersecurity incident disrupts systems, takes steps to limit impact

The medical device maker warned that the incident is expected to continue to disrupt its business operations.

By Nick Paul Taylor • Nov. 27, 2023

Smith & Nephew inks $180M CartiHeal buyout, capitalizing on Bioventus turmoil to land knee implant

Bioventus’ protracted buyout bid ultimately fell apart and opened the door to Smith & Nephew.

By Nick Paul Taylor • Nov. 27, 2023

FDA weighs in on SoClean’s field correction for CPAP cleaning machines

SoClean announced a voluntary field action last week to address user complaints related to improper set-up and unauthorized modifications.

By Nick Paul Taylor • Nov. 22, 2023

Medtronic wins pulsed field ablation CE mark, teeing up 2-front challenge to Boston Scientific

Medtronic received the mark for its single-shot PFA device, clearing the company to expand its portfolio of European atrial fibrillation devices.

By Nick Paul Taylor • Nov. 22, 2023

BD names ex-3M exec Ronald Silverman as chief medical officer

Silverman left 3M three months after the company installed a new leader at its health business.

By Nick Paul Taylor • Nov. 22, 2023

Medtronic CEO downplays the impact of obesity drugs on bariatric surgeries, diabetes unit

The company is the latest medtech to address concerns about how weight loss drugs may impact growth.

By Ricky Zipp • Nov. 21, 2023

FDA concerned Cardinal Health failed to mitigate risk of incompatible syringes

Days after posting the Class 1 recall notice, the FDA said changes made to certain syringes could lead to overdose, underdose, or delays in therapy or alarms.

By Nick Paul Taylor • Nov. 21, 2023

Medtronic receives FDA approval for renal denervation device

The company received approval for the hypertension treatment despite a mixed vote from an FDA advisory panel.

By Elise Reuter • Nov. 20, 2023