Anumana names Boston Scientific veteran Maulik Nanavaty as CEO

Nanavaty has taken up the post after spending 18 years at Boston Scientific, where he held senior roles in interventional cardiology and neuromodulation.

By Nick Paul Taylor • Oct. 20, 2023

Edwards receives CE mark for tricuspid valve replacement

The company expects to gain U.S. approval late next year.

By Elise Reuter • Oct. 19, 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

Supply disruptions are delaying surgeries and compromising patient care, survey finds

A patient safety nonprofit used the findings to call for “long-term, nationally coordinated solutions” to stop persistent shortages.

By Nick Paul Taylor • Oct. 19, 2023

Interventional Systems gets second 510(k) clearance for miniature robot

The FDA cleared the Micromate system to use CT navigation in procedures such as biopsies and ablations.

By Susan Kelly • Oct. 19, 2023

FDA finalizes COVID-era guidance, extending flexibility for some remote monitoring devices

The agency shortened its list of devices that can continue to undergo limited modifications without 510(k) filings.

By Nick Paul Taylor • Oct. 19, 2023

BD recycles 40,000 pounds of medical waste in circular economy pilot project

The collaborators assessed the feasibility of recycling medical waste such as plastic syringes.

By Nick Paul Taylor • Oct. 18, 2023

Abbott raises outlook amid strong Q3, sees momentum into 2024

Sales of the FreeStyle Libre continuous glucose monitor rose nearly 31% despite investor worries about the potential impact of weight-loss drugs on demand.

By Susan Kelly • Oct. 18, 2023

Siemens Healthineers partners to improve tuberculosis screening using AI

The company will work with the Global Fund to Fight AIDS, Tuberculosis and Malaria, providing free licenses and helping to integrate AI-enabled processes into clinicians’ workflows.

By Nick Paul Taylor • Oct. 18, 2023

J&J to restructure orthopedics business

The company announced the two-year restructuring in its third-quarter earnings call. It expects the changes to accelerate growth and enhance profitability, CFO Joe Wolk said.

By Elise Reuter • Oct. 17, 2023

Medtech can cope with GLP-1s but ‘fear and doubt’ suppressing stocks: analysts

J.P. Morgan analysts caution that stocks could continue to suffer through 2024 and 2025.

By Nick Paul Taylor • Oct. 17, 2023

GE HealthCare cuts formaldehyde levels in neonatal incubators with revised process

The FDA previously alerted healthcare providers to the potential for neonatal incubators to emit airborne chemicals.

By Nick Paul Taylor • Oct. 17, 2023

FDA: ‘We have had a very loud voice’ on EtO

The agency said it is working closely with the Environmental Protection Agency, which is slated to implement a final rule in March limiting ethylene oxide emissions for medical device sterilizers.

By Elise Reuter • Oct. 16, 2023

Masimo wins de novo authorization for measure of high blood oxygen levels

The ORi device is intended to support standard pulse oximetry by providing additional insights into patients with higher than normal oxygenation.

By Nick Paul Taylor • Oct. 16, 2023

J&J receives 510(k) clearance for foot fixation device, targets growing bunion market

The clearance comes shortly after Stryker introduced a minimally invasive system for treating bunions.

By Nick Paul Taylor • Oct. 16, 2023

FDA prioritizes guidance on AI, cybersecurity, pulse oximeters in stacked schedule for 2024

The administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for the upcoming financial year.

By Nick Paul Taylor • Oct. 13, 2023

GE HealthCare wins $44M BARDA contract to develop AI-enabled ultrasound

BARDA sees challenges with using ultrasound in trauma care, leading it to task GE HealthCare with developing an automated 4D system and AI algorithms.

By Nick Paul Taylor • Oct. 13, 2023

European Commission orders Illumina to divest Grail

The order includes an undisclosed timeline and potential additional fines. Illumina, which has been anticipating the decision, maintains the commission does not have jurisdiction over the completed merger.

By Susan Kelly • Oct. 12, 2023

Boston Scientific wins diabetic neuropathy approval, joining rivals in growing market

The expanded indication positions Boston Scientific to challenge Abbott, Medtronic and Nevro for the emerging opportunity in spinal cord stimulation to treat the condition.

By Nick Paul Taylor • Oct. 12, 2023

J&J’s Abiomed hit with FDA warning letter over Impella heart pump

The letter identifies quality system problems in a group of recalled devices and says monitoring software used with the pump requires premarket authorization.

By Susan Kelly • Oct. 12, 2023

Top medtech conferences remaining in 2024

With several key conferences already wrapped, some of the biggest industry events left this year include the American Diabetes Association’s 84th Scientific Sessions and Advamed’s annual meeting.

By Susan Kelly • Updated June 3, 2024

Getinge inks $320M Healthmark takeover to bolster US sterile reprocessing capabilities

Buying Healthmark strengthens the position of Getinge in the U.S., building on two recent acquisitions of sterile reprocessing technology.

By Nick Paul Taylor • Oct. 12, 2023

How Medtronic, Zimmer Biomet and Smith & Nephew are thinking about acquisitions, spinoffs

Executives from the three medical device firms said they expect more deal-making in the long term, but face tough discussions about valuations with targets.

By Elise Reuter • Oct. 11, 2023

Haemonetics inks $253M OpSens buyout, adding cardiology guidewires to portfolio

The takeover will give Haemonetics devices that complement its vascular closure products, analysts said.

By Nick Paul Taylor • Oct. 11, 2023

5 financial challenges facing the medtech sector: EY

Declining stock prices, M&A, investment and revenues are dogging the industry in a difficult year, according to a new report from the consulting firm.

By Elise Reuter • Oct. 10, 2023

J&J-backed HistoSonics gets de novo clearance for liver cancer treatment

The system offers a minimally invasive alternative to surgical resection and thermal ablation in patients with primary and metastatic liver cancers.

By Nick Paul Taylor • Oct. 10, 2023