Hamilton recalls ventilators that may fail to restart

One death and one injury have been tied to the safety problem, the Food and Drug Administration said in a recall notice.

FDA’s lab developed test rule could be first check on agency’s power post-Chevron

The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency regulations, such as the LDT final rule.

J&J limits use of Megadyne electrodes due to burn risk

The FDA said 15 injuries have been tied to the use of three models of Megadyne patient return electrodes.

FDA finalizes guidance on studying opioid use disorder treatments

The Center for Devices and Radiological Health is aiming to help companies manage challenges such as inaccurate participant reports of drug use.

Element raises $277M to challenge Illumina in sequencing market

The startup claims companies that choose its device over Illumina’s sequencer can save almost $1.5 million in three years.

FDA walks back injury, death reports on recent Philips BiPAP recall

The agency now says 10 injuries and seven deaths are associated with the problem. The updated numbers match figures shared by Philips and are significantly below the original report.

Updated July 11, 2024

FDA warns BD blood culture bottle shortage could impact diagnosis

BD said reduced availability of blood culture media bottles due to supplier issues has prevented it from meeting global demand.

Medtronic recalls endotracheal tubes over blockage risk

The Food and Drug Administration has told healthcare providers to stop using the two affected types of endotracheal tubes.

Roche wins CE mark for its first CGM

The clearance positions Roche to challenge Abbott and Dexcom for the European continuous glucose monitor market.

Updated July 10, 2024

Illumina buys Fluent Biosciences, adding single-cell analysis tech

Fluent’s kits compete with products from companies including 10x Genomics, an Illumina partner.

Federal officials step down from health AI group’s board

HHS officials Micky Tripathi and Troy Tazbaz resigned from their roles as non-voting members of the Coalition for Health AI, an industry group working to create standards for artificial intelligence in healthcare.

Philips recall of imaging coils tied to 12 injuries

Several models of coils used in MRI scanners were recalled due to the risk of overheating, which can cause serious burns.

Masimo offered up to $950M for consumer business

Final terms of the deal are still being discussed, and Masimo said it plans to negotiate a higher price.

Pulse drops 510(k) plan for PFA device after FDA requests clinical data

Analysts said the AFib device is now unlikely to come to market before late 2026.

Baxter considers sale of kidney care unit to PE firm: WSJ

Carlyle Group could reportedly pay more than $4 billion for Baxter’s Vantive business.

Quest to buy Lifelabs for $985M

Buying the Canadian laboratory company opens a new front in Quest’s rivalry with Labcorp and marks its third takeover in as many months.

BD to close Ireland facility, putting 170 jobs at risk

A company spokesperson said the decision follows a recent review and reflects a push to improve operational efficiency.

Masimo employees rally around CEO Kiani as proxy fight looms

Hundreds of healthcare engineers have joined managers to support founder and CEO Joe Kiani as he battles an activist shareholder for control of the company.

Medtech layoffs continue in 2024

Dexcom, Agilent Technologies and Cue Health are among the companies added to MedTech Dive’s roundup of layoffs coverage.

Updated July 3, 2024

Alcon buys Belkin Vision for $81M upfront

Alcon will gain access to a laser treatment for glaucoma that it plans to sell in the U.S. by the end of the year.

Roche sues Foresight and Stanford, alleging use of trade secrets

Roche said Stanford applied for patents relating to cancer detection and monitoring technology using its confidential information.