Masimo today promised to accept one of the board members proposed by Politan Capital Management under certain conditions while taking more shots at the activist investor’s leader. The device developer said it would appoint former Johnson & Johnson MedTech executive Michelle Brennan to the board if shareholders voted to expand it from five members to […]
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Hologic CEO MacMillan to chair Illumina’s board
Illumina (NASDAQ: ILMN) announced today that its board has elected Hologic CEO Stephan MacMillan to fill a new seat and become its non-executive chair. Edwards Lifesciences CFO Scott Ullem will fill a second new seat — bringing the number of board seats to 11 at the San Diego–based DNA sequencing and array-based tech developer. The […]
Medtronic names former Amazon consumer robotics VP as chief technology and innovation officer
Medtronic today announced it appointed former Amazon executive Ken Washington as chief technology and innovation officer. In this newly created role, Washington will leverage his extensive experience leading technology development and execution across industries, including robotics, consumer products, automotive and space. He will also become a member of the Medtronic Executive Committee. “This new leadership […]
New FDA clearance will boost Philips and Masimo partnership
Philips and Masimo today announced an FDA clearance that allows the incorporation of Masimo’s advanced monitoring tech into Philips’ existing high-acuity patient monitors. The FDA clearance allows the companies to use SedLine brain function monitoring, Regional Oximetry and CO2 measurements in Philips’ patient monitors, IntelliVue MX750 and MX850. This is the latest extension of Masimo […]
ABK Biomedical receives FDA IDE for tumor-treating microspheres
ABK Biomedical this week announced it received FDA investigational device exemption approval for its Eye90 microspheres yttrium 90 radioembolization therapy. The FDA IDE approval allows the Halifax, Nova Scotia–based company to commence a multi-center pivotal clinical study in the U.S. involving patients with an especially tough-to-treat form of liver cancer. “FDA approval of this pivotal […]
Bayer is making a big digital health play
Bayer announced that it has launched a business unit that will focus on precision digital health products across a range of everyday health categories. Bayer will prioritize developing digital solutions that enable people to make more informed health choices based on personal insights and novel delivery mechanisms, the company said in a news release posted […]
Masimo management trades blows with activist investor Politan
The fight for two seats on the Masimo board is heating up ahead of the medtech developer’s annual shareholder meeting next month. Masimo management and activist investor Politan Capital Management released dueling presentations over the last 24 hours in support of their respective director nominees. Previously: Masimo beats the Street in Q1 ahead of proxy […]
CardioRenal receives FDA breakthrough designation for Tenor at-home blood potassium measuring device
CardioRenal today announced it received FDA breakthrough device designation for its Tenor at-home blood potassium measuring device. Tenor is a connected medical device that combines multiple technologies to assist patients with chronic illnesses, including chronic kidney disease, in measuring their blood potassium levels from the comfort of their homes. Patients can collect blood for testing […]
iRhythm has an FDA warning letter over Zio AT quality systems
iRhythm stock is down today on news of an FDA warning letter involving its Zio AT mobile cardiac telemetry device. In a Form 8-K filed with the SEC yesterday, iRhythm said it received the warning letter on May 25. The warning letter resulted from an FDA inspection at the company’s Cypress, California facility that concluded […]
Exactech announces global release of next-gen GPS Shoulder
Exactech will mark the global release of the latest version of its ExactechGPS shoulder surgery navigation software at the annual Shoulder Masters Course in Amsterdam later this week. The launch is taking place in EMEA and APAC countries. It follows the first surgery in the United Arab Emirates earlier this month, leveraging the company’s Active […]
FDA clears Think Surgical handheld robotic knee surgery device
Think Surgical announced today that it’s received FDA 510(k) clearance for its TMINI miniature robotic system that assists with total knee surgeries. Here’s how Fremont, California–based Think Surgical described the TMINI system in its news release: “The TMINI system includes a wireless robotic handpiece that assists surgeons in performing total knee replacement. Following a CT-based […]
