Friday Q&A: Fujifilm’s Henry Izawa on navigating a tough hospital equipment market

The CEO of Fujifilm Healthcare Americas discusses integrating Hitachi’s diagnostic imaging business, new product launches and how hospital budgets are changing the market for imaging.

By Elise Reuter • April 7, 2023

Sernova defends record after investors attack ‘sluggish’ progress of regenerative medicine implant

The investors accused Sernova’s board of “complacently” overseeing “a period of eroding shareholder value.”

By Nick Paul Taylor • April 7, 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

Abbott faces Class I recall of 4.2M glucose readers on battery fire risks

Readers for Abbott’s FreeStyle Libre glucose monitoring systems could catch fire if improperly stored or charged, the FDA says.

By Peter Green • Updated April 7, 2023

Bioventus CEO departs after CartiHeal acquisition unravels

Ken Reali was asked to leave after a deal to buy CartiHeal fell apart. Bioventus’ share price has fallen more than 90% in the past two years. 

By Susan Kelly • April 6, 2023

Medtech servicing timelines and costs improve as technician turnover creates skills challenge

With experienced technicians retiring faster than their replacements are getting up to speed, the sector faces a potentially costly skills challenge.

By Nick Paul Taylor • April 6, 2023

Medtronic’s Hugo too similar to Intuitive’s surgical robot to displace the market incumbent: analysts

The analysts expect Medtronic to “find a place in specific markets” that Intuitive is yet to dominate.

By Nick Paul Taylor • April 5, 2023

Philips Trilogy Evo ventilators face another Class I recall

More trouble for Philips’ Respironics business as the company flags a problem with ventilators that could lead to under-delivery of oxygen due to inaccurate readings.

By Elise Reuter • April 4, 2023

Masimo receives De Novo nod from FDA for device designed to detect signs of opioid overdose

The system detects patterns associated with opioid-induced respiratory depression and sends alerts that escalate in line with the risk level.

By Nick Paul Taylor • April 4, 2023

Bain acquires Olympus life sciences unit for $3.1B

The company aims to expand its position as a workflow solution provider in life science and industrial markets.

By Susan Kelly • April 3, 2023

Medtronic, DaVita launch kidney care joint venture

The new company, called Mozarc Medical, will focus on kidney care technology including home dialysis.

By Elise Reuter • April 3, 2023

Grassroots innovation: How a patient-driven device for diabetes won FDA clearance

Tidepool Loop, an automated insulin dosing app based on one developed by the DIY diabetes community, received FDA clearance in January. 

By Elise Reuter • April 3, 2023

Getinge’s quality woes continue: FDA categorizes another heart pump recall as Class I event

The recall is the latest in a series of compliance problems for Getinge, which has had CE marks for two products suspended.

By Nick Paul Taylor • April 3, 2023

Philips CEO Jakobs expects first settlement on respirators this year, Dutch newspaper says

Jakobs said he “hopes and expects” to reach a settlement with the Food and Drug Administration this year; settling suits over alleged medical damages may take longer.

By Peter Green • March 31, 2023

Friday Q&A: Nevro CMO tells how the spinal device maker will defend its turf in diabetic pain relief

Dr. David Caraway says Nevro’s device stands apart from competing treatments for painful diabetic neuropathy with its clinical data and approach. The company is also launching a new product.

By Elise Reuter • March 31, 2023

Safety of fixed palatal expanders probed by FDA amid patient lawsuits

The investigation follows lawsuits from patients who say the device damaged their teeth and gums, and eroded their jawbones. 

By Nick Paul Taylor • March 31, 2023

FDA qualifies tool for predicting temperature rise when orthopedic implants enter MRI scanners

Device makers can use the tool to identify femoral nail designs that would be less suitable for use in people who may undergo MRI.

By Nick Paul Taylor • March 31, 2023

FDA drafts guidance to ease path to updates for AI-enabled devices

The guidance describes a framework for changes to medical devices that use machine learning.

By Elise Reuter • March 30, 2023

Surmodics receives FDA feedback weeks after layoffs

Last month, Surmodics laid off 13% of its workforce, blaming regulatory approval delays, which also halted a $24 million milestone payment from Abbott as the firms work on a treatment for peripheral arterial disease.

By Susan Kelly • March 30, 2023

ICU Medical challenges GE HealthCare for Medtronic units valued at $8B: report

Medtronic wants to spin off or sell the two units to focus on faster-growing parts of its business and is talking to potential buyers.

By Nick Paul Taylor • March 30, 2023

FDA says it won’t issue ‘refuse to accept’ letters on cyber devices before Oct. 1

Until October 1, the FDA will work with device makers to ensure pre-market submissions have adequate cybersecurity information.

By Elise Reuter • Updated March 30, 2023

In a threat to diabetes tech market, scientists use implanted glucose-run fuel cell to power insulin release

If commercialized, the technology could disrupt continuous glucose monitor and insulin pump markets fought over by companies including Abbott and Medtronic.

By Nick Paul Taylor • March 29, 2023

Getinge heart pump has CE mark suspended by second notified body, halting sales for 3 months

TÜV SÜD took the action over concerns related to risk management, post-market surveillance and vigilance, and the timeliness of field safety corrective actions.

By Nick Paul Taylor • March 28, 2023

Implantable heart failure sensors cut death risk in study: Abbott

Philip Adamson, chief medical officer for Abbott’s heart failure business, called the finding “profound.”

By Susan Kelly • March 27, 2023

Hospitals expect procedures, capital equipment budgets to grow next year: survey

Cash-strapped hospitals say they will continue to ask medical device companies for price reductions and payment flexibilities, a survey by BTIG found. 

By Elise Reuter • March 27, 2023

Bill would require Medicare to cover breakthrough devices for four years

The bipartisan legislation, if enacted, would speed the coverage determination process for FDA-approved devices.

By Susan Kelly • March 27, 2023