Your Go-To Source for MedTech Industry News
Welcome to MedTech Monitor, your weekly update on the latest news and trends in the medtech industry.
?? Want more industry news? Sign up for our daily newsletter to receive an enhanced edition of MedTech Monitor directly to your inbox.
?? Discover the pulse of innovation in healthcare with Let's Talk MedTech, MD+DI's podcast featuring industry leaders from across the world of medtech and healthcare.
Let's dive into the weekly news...
What the Heck is Going on at Baxter?
By Katie Hobbins, Managing Editor
Baxter International, on the heels of its Life2000 ventilator recall, yesterday announced the recall of certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly.
The Volara system, when used in conjunction with a ventilator and without a nebulizer connected to the blue ventilator adapter, is required to have the handset plug to help ensure proper operation and ventilator gas flow. The company is recalling the blue ventilator adapter after reports the handset plug may disconnect from the nebulizer port on the blue ventilator adapter. If this were to happen and go unnoticed prior to or during therapy, it could lead to an interruption or delay in care, resulting in “reduced ventilation and oxygenation due to the ventilator leaking gas flow from the nebulizer port on the blue ventilator adapter,” according to the recall notice.
Baxter has instructed customers to stop using the blue ventilator adapter. If a patient does not have another therapy option, the company said, “they may continue to use it with caution. Customers are instructed to visually inspect the nebulizer port prior to therapy and check for any ventilator gas flow leaks for the duration of therapy.”
The recall applies to the Volara system single-patient use circuit with product codes M08473 and M08474, and the blue ventilator adapter assembly with product code M07937. The affected product was distributed between Aug. 26, 2022, and Dec. 30, 2023. Currently, no injuries have been connected to the issue.
Earlier this week, MD+DI reported that Baxter also initiated a recall for its Life2000 ventilators with an attached battery charger dongle.
The company informed customers that when damaged, the battery charger dongle is unable to charge the ventilators internal battery. If it fails to charge, a patient would not be able to use the device. For patients requiring Life2000 support, an inability to use the device could result in oxygen desaturation episodes that range from mild to potentially life-threatening.
Both the Volara and Life2000 ventilators are no strangers to FDA ire. In 2022, Baxter was embroiled in a Class I recall of the Volara after receiving reports of two device-associated deaths. In early 2023, Life2000 had a device correction due to the risk of patient oxygen desaturation when connected with a third-party oxygen concentrator.
Baxter declined MD+DI's request for comment.
Masimo-Politan Proxy War Goes from Bad to Ugly
In what were supposed to be the final days of its proxy war against Masimo, Politan Capital Management may have found itself in zugzwang this week, with no good options to counter the company's latest move. Masimo has delayed its shareholder vote by eight weeks. Ultimately, we now have two lawsuits to follow, and the vote is postponed from July 25 to September 19.
Masimo's board approved the postponement of the company's annual shareholder meeting (and subsequently, the shareholder vote) on Monday. The company noted that the Securities Exchange Commission requires a broker search to be conducted 20 business days before the meeting, so the company also had to conduct a new broker search. The new record date for determining Masimo stockholders entitled to receive notice of and vote at the 2024 annual meeting will be August 12.
Masimo also launched a lawsuit against Politan, asking a federal court to intervene and make Politan correct alleged material misstatements and omissions from its proxy materials.
Masimo said the board postponed the meeting to accommodate Politan's request for a new record date for the meeting and to give shareholders sufficient time to review revised proxy materials before the vote. But Politan countered with a lawsuit against Masimo and three of its directors to ensure that the annual meeting is held as soon as possible with no further delays. In the complaint, Politan alleges that the two-month delay is unnecessary, in violation of Masimo's own bylaws, and a "manipulation of the corporate machinery to entrench the incumbent board."
Below is a timeline of key developments that have taken this proxy war from bad to ugly:
*MD+DI independently verified that at least some engineers who signed the letter of support for Kiani were pressured into doing so. It seems most of the engineers did not feel pressured to sign, but this is based on just 18 responses to our survey of nearly 300 engineers.
Politan accuses Masimo of empty voting tactics
Politan had previously called Masimo out for alleged "empty voting" tactics, but the activist investor claims a record date could have been set as early as July 18 (today), in which case the annual meeting could have been postponed by just a couple of weeks (until the first week of August) instead of two months. Politan also denies Masimo's allegations of misstatements in its proxy materials.
Politan raised concerns in its proxy materials that an investor who had voted for Masimo's nominees may have engaged in what is known as "empty voting" or "record date capture" – voting shares without economic exposure, achieved by borrowing the shares, then shorting them.
Politan asked Masimo to move the record date without moving the annual meeting date. Politan has also asked the board to look into whether a 13D/SEC violation has occurred.
Masimo claimed in an SEC filing responding to Politan's request that neither Kiani nor any other member of management nor the non-Politan members of the board had or has any agreement, arrangement, or understanding with regard to the trading or voting of Masimo stock by any third-party investor.
领英推荐
GE HealthCare Emphasizes AI with New M&A
By Omar Ford
GE HealthCare is making an acquisition to expand its portfolio of artificial intelligence-enabled devices in imaging.
The Chicago, IL-based company said it has entered into an agreement to acquire the clinical AI business from Intelligent Ultrasound for $51 million.
Intelligent Ultrasound specializes in integrated AI-driven image analysis tools designed to make ultrasound smarter and more efficient. Intelligent Ultrasound said it ?has pioneered the ScanNav Assist AI technology, which powers SonoLystlive?and SonoLyst X/IR, available on GE HealthCare’s Voluson Expert and Voluson Signature ultrasound devices.
"We are pleased to bring innovative technology from Intelligent Ultrasound into GE HealthCare’s Ultrasound portfolio, allowing us to fully integrate these solutions into our systems to help clinicians improve workflow, reduce repetitive tasks, and simplify exams,” said Phil Rackliffe, president and CEO of Ultrasound and Image Guided Therapies, GE HealthCare said in a release. “This technology and the experts who developed it will help enhance our portfolio of AI-enabled devices and accelerate our pace of development of next-generation AI tools.”
The deal comes a little more than a year after GE HealthCare added another piece to its growing AI puzzle by acquiring Caption Health. The San Mateo, CA-based company specializes in using AI to assist in conducting ultrasound scans.
Related: GE Healthcare to Stand on Its Own
In September of last year, Jan Makela, President and CEO of imaging at GE HealthCare, was a guest on the Let’s Talk Medtech podcast to discuss the company’s plans for imaging and AI.
You can access the episode here.
What Does the Future Hold for ZimVie?
By Omar Ford
ZimVie was one of the hottest companies to come out of the ‘spinoff era’ that defined medtech during the ‘middle’ days of the pandemic.
However, the company – which was once part of Zimmer Biomet, struggled to find its footing. Now the dental implant maker is looking at a potential sale, according to a report from Bloomberg.
The report said ZimVie is exploring alternatives after receiving interest from potential buyers, which include buyout firms and companies in the industry.
The move comes a few months after ZimVie sold its spine business to H.I.G. Capital in a deal valued at $375 million. The deal was first announced in December of 2023. The spine business’s name was changed to Highridge Medical.
ZimVie has a market capitalization of $521.90 million.
Recommended Reads ??
?? Advancements in Digital Biomarkers & Medical Diagnostics: Can ethical considerations keep up with evolving AI and AIML technology?
?? How to Navigate FDA's Medical Device Cybersecurity Recommendations: FDA is cracking down on medical device cybersecurity. These experts will help you stay compliant.
?? BD Bactec Blood Culture Media Bottles in Shortage: FDA today added the product to the Medical Device Shortage List after projections that supplier issues could cause disruptions in availability.
?? 5 Things Medtech Is Talking About in July: Your visual roadmap to the hottest medtech topics this month.
?? Tufts Medical Center to Adopt Molli Surgical Breast Cancer Tech: The system has been lauded as one of the next best things in medtech for its approach to mark breast cancer lesions for surgical removal.
Upcoming Industry Events ??
MEDevice Boston | Sept. 25-26, 2024 | Boston, MA
MD&M Minneapolis | Oct. 16-17, 2024 | Minneapolis, MN
MEDevice Silicon Valley | Nov. 20-21, 2024 | Santa Clara, CA
MD&M East | June 10-12, 2025 | New York, NY