The election of two new directors to Masimo’s board last month could set the stage for a sale or spinoff of the medtech company’s Sound United consumer audio division, analysts at Needham said in a report on Monday.

Martin Fischer will join Fresenius Medical Care as CFO starting on Oct. 1. Previous CFO Helen Giza was promoted to CEO. buff.ly/3PMsfCV

CMS is set to propose outpatient reimbursement that will increase sales of Shockwave Medical’s heart disease device, Morgan Stanley analysts wrote in a note. buff.ly/3NLfGoD

Researchers and physicians at the University of Pittsburgh and UPMC developed a machine learning model that can identify patients who are at high risk for complications after surgery, according to a study published Friday in JAMA Network Open. buff.ly/43pGwZk

The European Commission on Wednesday fined gene sequencing pioneer Illumina about €432 million ($480 million), the maximum penalty it could impose, for closing the 2021 acquisition of cancer test developer Grail without first gaining the commission’s approval.

Tandem Diabetes Care received FDA clearance for its Mobi insulin pump, a smaller form-factor device that could drive growth for the company next year. buff.ly/44rHUMn

Megadyne’s recall of electrode pads was classified by the U.S. Food and Drug Administration as a Class I event due to the risk of serious burn injuries. buff.ly/3PSenXG

The FDA has found paclitaxel-coated devices are unlikely to increase the risk of death when used to treat peripheral arterial disease, leading it to work with device-makers to update labeling. buff.ly/3NQvqGT

The U.S. International Trade Commission (ITC) has delayed a decision on a patent dispute between Apple and Masimo until October. buff.ly/3DbjVF9

The FDA approved Urotronic’s minimally invasive surgical treatment of symptoms linked to benign prostatic hyperplasia (BPH), offering another option to devices made by Teleflex and Boston Scientific. buff.ly/3NY7Ica

Becton Dickinson disclosed that it has identified eight cybersecurity vulnerabilities in its Alaris infusion pump system. buff.ly/44M7Gun

QuidelOrtho’s recall of a test to detect heart attacks was labeled Class I by the FDA. The company received reports that the tests showed lower than expected troponin levels, and advised clinicians to immediately stop using them. buff.ly/44sUz1H

Responding to concerns about the safety of hernia mesh devices, the FDA analyzed the adverse event reports it has received over the past 22 years and reviewed 45 research papers published in the past 11 years. buff.ly/44L5iEk

ViewRay, a company that makes an MRI-guided radiation therapy system for cancer treatment, filed for Chapter 11 bankruptcy. buff.ly/3DksBJw

Big Health has bought Limbix to add a treatment for adolescent depression to its portfolio of digital therapeutics. buff.ly/3XYJR0q

Medtronic is recalling nearly 350,000 implantable defibrillators because the devices may deliver a reduced-energy shock, or no shock at all, when therapy is needed, the FDA said Tuesday. buff.ly/3ryAkRw

A clinical trial found that overall, treating hearing loss in older adults had no effect on the rate of cognitive decline over three years. But a smaller analysis showed a big difference in adults who were at increased risk for cognitive decline. buff.ly/3Onr7oh

J&J subsidiary Abiomed's heart pumps can potentially interact with transcatheter aortic valve replacement (TAVR) stents, causing damage to the heart pump’s motor, according to a recall notice. buff.ly/46WEgM7

J&J raised its full-year earnings forecast for the second quarter in a row, reflecting improved procedure volumes and new product launches in its medtech segment. buff.ly/3K5wkyi

GE HealthCare raised its revenue and earnings expectations for 2023 as it plans to cut costs. buff.ly/44KSpun