Why medical device designers need to become more agile — and how they can do it

To stay competitive, medtech firms must center manufacturing in business optimization plans, while embracing a design-to-value approach, says Jennifer Samproni, Flex’s chief technology officer for its Health Solutions division.

By Jennifer Samproni • Jan. 26, 2023

Medtech regulation outlook in 2023: Faster approvals among priorities as AI moves to fore

Leaders in the medtech field weigh in on the prospects and challenges for product regulation in 2023.

By Peter Green • Updated Jan. 26, 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

Researchers create remote-controlled biological robot that could eventually be used in surgery

The design allows the integration of sensors and other components that could eventually equip the robots to detect biomarkers of disease, carry out biopsies or perform surgery.

By Nick Paul Taylor • Jan. 26, 2023

Getinge heart pump gets third Class I recall after patient death

Customers were alerted to problems with Cardiosave devices late last year after Getinge received complaints about an issue linked to four serious injuries and one death.

By Nick Paul Taylor • Jan. 26, 2023

Abbott sees ‘signs of stability’ for 2023 as hospital staffing, supply chain improves

While the company continues to grapple with supply shortages and procedure restrictions, it sold more COVID-19 tests than expected in the fourth quarter.

By Elise Reuter • Jan. 25, 2023

Cybersecurity ‘more critical than ever’ in era of connected care: BD

The device maker’s annual report on the state of healthcare cybersecurity calls for better transparency and coordination across the industry.

By Susan Kelly • Jan. 25, 2023

Intuitive Q4 profit slips on costs to boost share of robotic surgery market

The investment in innovation comes as Intuitive tries to maintain its dominant position in the face of rivals including Johnson & Johnson and Medtronic.

By Nick Paul Taylor • Jan. 25, 2023

3M’s healthcare unit Q4 earnings drop on nurse shortages, falling hospital budgets

Elective healthcare procedure volumes were about 90% of pre-COVID levels.

By Nick Paul Taylor • Jan. 25, 2023

J&J sees Abiomed adding to revenue in 2024; Q4 sales drop

Foreign-exchange fluctuations helped curb revenue in the period.

By Peter Green • Jan. 24, 2023

Insulet reports personal-data leak of 29,000 insulin pump customers

In a recall communication to users, Insulet shared information with its website performance and marketing partners through cookies and other trackers embedded in its website. 

By Nick Paul Taylor • Jan. 24, 2023

Medtronic asks HVAD users to return batteries with welding defects

The recall is one of several related to battery issues after the heart pump was pulled from the market.

By Elise Reuter • Jan. 23, 2023

3 questions for Michael Snyder, lead inventor of single-drop blood test

The head of a Stanford research team says the test differs from Theranos' defunct product because "ours works."

By Peter Green • Jan. 23, 2023

Ethylene oxide regulation may disrupt device supply, AdvaMed warns White House

The trade group has asked President Joe Biden to consider the potential threat to patient care if facilities are shut down.

By Nick Paul Taylor • Jan. 23, 2023

FDA demands additional data on Abbott rival to Medtronic balloon, setting back approval timeline

Abbott’s partner Surmodics is “evaluating options” to reduce its spending while preparing a response to the regulator’s requests.

By Nick Paul Taylor • Jan. 20, 2023

Dexcom CEO discusses 2023 plans, expanding to more patients with Type 2 diabetes

MedTech Dive caught up with Kevin Sayer for a conversation about forthcoming product launches and long-term plans to expand CGMs to a broader group of patients. 

By Elise Reuter • Updated Jan. 20, 2023

Medtech hazards: Problems with Philips’ recall put safety of home-use devices at top of danger list

Patient safety group ECRI is challenging manufacturers to provide easy-to-follow device registration instructions and write simply worded recall notices.

By Nick Paul Taylor • Jan. 19, 2023

Abbott’s FDA approval for TAVI device tees up challenge to Edwards, Medtronic: analysts

Abbott has captured about 9% of the European market and aims to become a “credible third player” in the U.S.

By Nick Paul Taylor • Jan. 18, 2023

Shockwave to pay $100M for Neovasc, adding refractory angina treatment to device pipeline

Neovasc already has a CE mark for the device and last year said it was targeting a 2025 approval by the FDA.

By Nick Paul Taylor • Jan. 18, 2023

Medtech companies start 2023 on ‘optimistic’ note amid earnings forecasts, staffing: J.P. Morgan

Executive comments at the healthcare conference in San Francisco suggest companies expect staffing pressures and supply constraints to improve in 2023, analysts say.

By Elise Reuter • Jan. 17, 2023

AI predicts lung cancer risk six years into the future using single CT scan: study

A research team has made the deep learning model publicly available and says it has no intention to commercialize it.

By Nick Paul Taylor • Jan. 17, 2023

iRhythm shows signs of progress even as it ‘still has a way to go’ on key challenges: William Blair

The company should come close to its revenue estimate when reporting fourth quarter results, according to analysts.

By Nick Paul Taylor • Jan. 13, 2023

‘Mixed signals’ from medtech management suggest industry had bumpy end to 2022: analysts

The recovery of procedure volumes was “muted and uneven” in the fourth quarter with growth throttled by hospital staffing issues and worker absenteeism.

By Nick Paul Taylor • Jan. 13, 2023

Olympus gets two FDA warning letters over safety of reprocessed endoscopes

The regulator said the companies didn’t adequately test the device assembly process and waited too long to report problems from complaints.

By Elise Reuter • Jan. 12, 2023

Google sibling Verily to lay off about 200 workers as it focuses on precision risk business

The company, which has more than 1,600 employees, will stop work on some products including its healthcare analytics software program.

By Nick Paul Taylor • Jan. 12, 2023

Intuitive forecasts 12%-16% growth in procedures in 2023 even as da Vinci robot sales slowed in Q4

For hospitals that have been reporting growth in robotic procedures, “da Vinci is a relative priority in their capital budgets,” the company said.

By Elise Reuter • Jan. 11, 2023