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Follow the Money: Which U.S. Presidential Candidate Is Medtech Supporting?
Traditionally, the medical device industry's primary interests in Washington have been in the activities of the U.S. Patent and Trademark Office and FDA. However, according to OpenSecrets.org , medtech's rise to prominence in terms of both lobbying and campaign contributions began early in the Obama administration's first term, driven largely by the debate over the Affordable Care Act .
The following data, sourced from OpenSecrets.org shows how much money the pharmaceutical and medical products industry (including medical devices) contributed to each of the U.S. presidential candidates in the 2023-2024 election cycle. For an explanation of OpenSecret's methodology, see information below the chart.
All the numbers in this chart are for the 2024 election cycle and based on Federal Election Commission data released electronically on September 22, 2024.
Methodology: The numbers on this page are calculated from itemized contributions as reported to the Federal Election Commission, which are donations itemized once someone donates over $200 to a campaign. Individual donations under $200 must be itemized if they exceed $200 or are part of an aggregated total of more than $200 when added to other contributions received from the same individual. PAC dollars are not included.
We also looked at the top contributors in the current election cycle from medical device companies. This data was also sourced from OpenSecrets.org .
Is Intuitive the Coca-Cola of Surgical Robotics?
By Omar Ford
There’s no disguising the fact that there’s a great deal of demand for Intuitive Surgical’s Dv5 platform. Executives from the Sunnyvale, CA-based company spoke about the hot demand for the fifth iteration of the da Vinci surgical platform, which received a nod from FDA in March .
News of the demand caused Intuitive’s shares to surge more than 10% last week .
The device is currently in a limited launch with a broader launch scheduled for mid-year in 2025.
Jamie Samath, Intuitive’s CFO, said Dv5 led the surge in demand, according to a Seeking Alpha transcript of the call.
“U.S. system placements in the quarter included 110 DaVinci 5 placements,” Samath said according to a Seeking Alpha transcript of the call. “As supply of Dv5 increases and we move into broad launch mid-next year, we expect that placements in the U.S. will progressively shift toward transactions. Outside the U.S., we placed 160 systems in quarter three, compared with 153 systems last year.”
Ryan Zimmerman, an analyst with BTIG, wrote about the demand and the impact it could have in 2025.
“With a growing slate of regulatory approvals for Dv5 (i.e. new geographic markets) we expect the pace of Dv5 growth to continue even into the broader launch in 2H25,” Zimmerman wrote.
The surgical robotics market is bursting with competitors – especially in the soft tissue segment of the space. Johnson & Johnson became a hot topic of discussion in surgical robotics last week when it announced it submitted Ottava to FDA for an IDE.
Related: 5 Big Moments for Surgical Robotics
The submission comes about three years after the Brunswick, NJ-based company said it was delaying its robotics program. J&J first revealed the platform in November of 2020.
Hologic to Lay Off 86 as Danbury Facility Shutters
领英推荐
By Katie Hobbins , Managing Editor
Hologic CFO Karleen Oberton’s March comments calling mass layoffs a “failure of leadership” is once again coming back to haunt the company. The medical technology company recently notified the Connecticut Department of Labor of the intent to lay off 86 employees from Dec. 20 through Q1 2025 at its closing Danbury, CT facility.
The closure comes after Hologic officials, in October 2021, announced that work being done at the Danbury facility would be relocated to Newark, DE, where the location would be expanded to centralize manufacturing with R&D. Now officially shuttering its doors on Dec. 20, 71 employees will be laid off on that date. After the building closure, a small number of permanent, full-time employees will remain to conduct final post-closure activities, according to the company. Of that number, three workers will be cut on Jan. 31, 2025, and 12 more will be laid off on or around Feb. 14 through Feb. 21, 2025.
Q124 was rife with Hologic announcing company priority shifts, how it was discontinuing certain products, and would close an undisclosed number of international diagnostic division facilities.
In May, the company defined some of its more radical changes, including the closure of its Finland and France facilities , deciding to move key development activities and operations to its San Diego, CA, location. With the closures, 190 total employees across the two locations were terminated.
“During the first quarter of fiscal 2024, the company further refined its strategy for the Mobidiag business, which is within the diagnostics reportable segment,” the SEC filing wrote. “The strategy change included the decision to discontinue the manufacture and sale of certain products, closure of its facilities in Finland and France, and to move the development activities and operations to the company’s San Diego, California location. In connection with this plan, the company finalized its decision to terminate the employees at these locations, totaling 190.”
The ongoing personnel changes with Hologic stand in stark contrast with Oberton’s biting words for medtech executives laying off employees in the industry, telling The Wall Street Journal in March that the company has avoided these actions by carefully managing its hiring. She told the journal that, even before the COVID-19 pandemic, Hologic operated under a “philosophy that mass layoffs are a failure of leadership.”
Seems Hologic may be throwing stones in glass houses.
Trouble in PFA Paradise: Boston Sci Pauses AVANT GUARD Trial
By Omar Ford
Yes, pulsed-field ablation (PFA) is one of the hottest segments of medtech right now, but that doesn’t mean there won’t be bumps in the road.
Boston Scientific reported such a bump when it announced it was temporarily pausing its AVANT GUARD trial. The study is looking at how the company’s Farapulse PFA could treat a new patient population of drug-na?ve persistent atrial fibrillation patients.
Kenneth Stein, Boston Scientific’s Global Chief Medical Officer, commented on the decision to pause the trial, according to a Seeking Alpha transcript of the company’s 3Q earnings call. He noted that this was an entirely new patient population that the Farapulse was treating.
“... Due to a few unanticipated observations in the trial, which is studying a completely new population, which is drug-naive patients with persistent atrial fibrillation, which Farapulse is not currently indicated to treat - we did elect to temporarily pause enrollment until we develop a better understanding of the observations,” Stein said according to a Seeking Alpha transcript of the call. “While none of the observations were life-threatening, we did make a decision to temporarily pause, but it is our intention to resume enrollments in the near term.
Despite having a strong earnings report, news of the temporary pause caused shares of the Marlborough, MA-based company to drop by 4%.
Marie Thibault, an analyst with BTIG, wrote that the delay does not appear to be significant and is overshadowing a strong earnings report that had Boston Scientific increasing its full-year guidance.
“While we do not think there is cause for alarm since the 'unanticipated observations' are not life-threatening, the hyperfocus on Farapulse means Boston Scientific is trading down despite a stellar report,” Thibault wrote in a research note. “We think this is short-sighted, especially since enrollment is expected to resume soon, but acknowledge wariness about anything going wrong with a key product and potential TAM-expanding effort.”
News of the AVANT GUARD trial delay comes a day after the company reported winning a nod for the Farawave Nav Ablation Catheter . The technology provides visualization for Farapulse procedures.
The PFA space is one of the hottest sectors in medtech. Boston Scientific is competing with Medtronic, which was the first company to win FDA approval in the space , and Johnson & Johnson.
Boston Scientific won FDA approval for the Farapulse earlier this year.
Recommended Reads ??
? Troubles Mount for Baxter as Life2000 Slapped with Another Recall Notice: More than one Hillrom-made device continues to be a thorn in the company’s side since the highly publicized acquisition in 2021.
? Medtronic Earns Another PFA Approval, Is J&J Next in Line?: The Dublin-based company’s FDA nod arrives amid a surge of activity in the pulsed-field ablation market.
? Michelle Tarver Is Officially the New Leader at FDA's Center for Devices and Radiological Health: Michelle Tarver has been serving as acting director at CDRH since July, when longtime leader Jeff Shuren stepped down.
? Philips Shares Sharply Decline After Lowering Guidance: The Amsterdam-based company cited a lack of demand in China because of slumping sales.
? Will CHIPS Act Momentum Continue Under the Next President?: The answer is yes, but there are areas where differences in implementation could surface.
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