Illumina’s ‘inevitable’ split from Grail likely by mid-2024, analysts say

Canaccord Genuity analysts, commenting on a Financial Times article predicting a record EU fine against the DNA sequencer for closing its Grail acquisition, said it looks “almost certain” regulators will force a divestiture.

By Susan Kelly • July 6, 2023

FTC intervenes to correct Medtronic’s ‘erroneous assertions’ in antitrust case

The FTC filed an amicus brief because it said Medtronic made “wrong” arguments with “broad implications for antitrust enforcement.”

By Nick Paul Taylor • July 6, 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

European guidelines offer support for renal denervation in hypertension, boosting Medtronic, ReCor

Medtronic hailed the updated guidelines as a “turning point” for the use of renal denervation in treating high blood pressure.

By Nick Paul Taylor • July 6, 2023

Medtronic identifies cybersecurity vulnerability in cardiac data system

Cyber attackers could exploit the vulnerability if healthcare organizations have enabled its optional messaging service, the device maker said.

By Susan Kelly • July 5, 2023

Abbott secures FDA approval for dual-chamber leadless pacemaker

With the new device, Abbott is ramping up competition with Medtronic in the leadless pacemaker market.

By Elise Reuter • July 5, 2023

Startup’s fast-acting wound treatment gel gets FDA nod for use in humans

Cresilon raised $25 million last year as part of a push to expand its wound-gel product for animals into human health.

By Nick Paul Taylor • July 5, 2023

Q&A: Dexcom’s Lawver shares strategy behind CGM for non-insulin users

The continuous glucose monitor in development for people with Type 2 diabetes who don’t take insulin could expand the CGM market to 25 million more people in the U.S., the company’s new chief commercial officer said.

By Elise Reuter • June 30, 2023

Diabetes remains fastest-growing medtech market despite some risk from new drugs: analysts

The medicines could apply “short-lived pressures” to medtech companies by affecting the use of insulin, Mizuho analysts say. 

By Nick Paul Taylor • June 30, 2023

EU MDR costs could cause device shortages for children, medical groups warn

The cost of certification under new medical device regulations in Europe is a barrier to manufacturers that make devices for small groups of patients, medical associations said.

By Elise Reuter • June 29, 2023

FDA seeks feedback on technologies that can enable healthcare at home

The FDA is asking the medtech industry for input on how the agency can support development of devices for use in non-clinical care settings and by diverse patient populations.

By Nick Paul Taylor • June 29, 2023

FDA repeats restrictions on NuVasive limb-lengthening device after clearing pediatric use

The agency in March cleared NuVasive to market its Precice limb-lengthening system for use in the femur and tibia of children aged 12 years and up.

By Nick Paul Taylor • June 29, 2023

Former J&J sales rep indicted on charges of defrauding Boston hospital

The former J&J employee is accused of bilking the hospital out of hundreds of thousands of dollars’ worth of spine products.

By Susan Kelly • June 28, 2023

Teleflex recall of separating vascular catheters labeled Class I event

The company began the recall in May after receiving 83 complaints, including 18 reports of injuries, related to the fault.

By Nick Paul Taylor • June 28, 2023

Invacare names Kai Zhu as CFO

The promotion positions Zhu to help lead the manufacturer of non-acute care medical equipment as it works to recover from a bankruptcy filing.

By Nick Paul Taylor • June 28, 2023

Proposed EtO limits garner criticism from device industry, praise from occupational health groups

Lobbyists representing medical device companies say the proposed policy would reduce capacity at commercial sterilizers by as much as 50%.

By Elise Reuter • June 27, 2023

Masimo shareholders elect activist investor’s two board candidates

The vote approving Politan Capital’s nominees is “a clear mandate from shareholders that significant change is needed at Masimo,” said newly elected director Quentin Koffey.

By Susan Kelly • Updated June 27, 2023

Restor3d inks Conformis buyout, adding hip and knee implants to portfolio

Restor3d, which makes 3D-printed devices for spine, ankle and upper extremity procedures, is buying Conformis at a 96% premium. 

By Nick Paul Taylor • June 27, 2023

More than 1 billion people could have diabetes by 2050, study says

A pair of studies published in the Lancet show that spending on diabetes care is expected to rise, but more work is needed to address structural inequities that affect access to treatment.

By Elise Reuter • June 26, 2023

Medtronic links 780G insulin pump to benefits in kids as it works to grow sales

A clinical trial found adolescent users of the pump can achieve improved blood glucose control without precisely counting carbohydrates.

By Nick Paul Taylor • June 26, 2023

Dexcom targets 25M Americans with new CGM aimed at non-insulin-using diabetics

The device will last for 15 days, include a cash-pay option and come with software designed for the needs of people who are yet to require insulin.

By Nick Paul Taylor • June 26, 2023

Showdown at Masimo: Proxy battle targets CEO Kiani’s leadership, board

Shareholders are voting on whether to add investor Politan Capital’s picks to the board of the pulse oximeter maker, a move that could change the company’s direction.

By Susan Kelly • June 23, 2023

Intuitive’s Ion platform may provide ‘most exciting advancements in robotic technology’: analysts

Intuitive’s da Vinci robotic surgery platform is the most widely used robot in the industry and analysts expect demand for bronchoscopy and tumor ablation to fuel growth for the company’s Ion system. 

By Nick Paul Taylor • June 23, 2023

Sterigenics moves closer to end of ethylene oxide lawsuit as most claimants accept $408M deal

The agreement allows the company to put the lawsuits behind it, while leaving Sterigenics’ future open as U.S. regulators push to limit the use of the medical device sterilization chemical.

By Nick Paul Taylor • June 23, 2023

Medtronic will distribute Allurion’s swallowable weight-loss balloon

An innovation in obesity treatment can extend the benefits of bariatric intervention to the overweight without the need for surgery, and will be tried in developing markets of eastern Europe, the Middle East and Africa.

By Susan Kelly • June 22, 2023

GE HealthCare partners with J&J to push spine imaging system

Striking the deal to bring its OEC 3D systems and DePuy Synthes devices to U.S. surgeons continues the streak of partnerships formed by GE HealthCare to broaden the distribution of its products.

By Nick Paul Taylor • June 22, 2023