Medical Innovation Exchange

Medical Device

FDA warns against using smart wearables that claim to measure blood sugar

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Dive Brief:

The Food and Drug Administration warned patients against using smartwatches or smart rings that claim to measure blood sugar without piercing the skin. 
Officials published the safety notice Wednesday after learning that people are selling wearables that claim to noninvasively monitor blood glucose. The devices are “manufactured by dozens of companies and sold under multiple brand names,” according to the agency. 
The FDA has never authorized a noninvasive wearable that measures or estimates blood glucose values on its own and is concerned inaccurate readings could lead to errors in the management of diabetes.

Dive Insight:
Samsung is working to add noninvasive glucose monitoring to its smartwatches and Apple reportedly set up a group focused on the challenge years ago. Google’s life science group,Verily, disclosed a push to create a contact lens that can measure blood sugar in 2014 but stopped work in 2018 after tests showed “insufficient consistency” between the concentration of glucose in tears and blood.
While some of the biggest companies on earth have so far failed to create noninvasive glucose monitors, little-known brands are selling smartwatches and rings that claim to track blood sugar for less than $50 online. The FDA became aware of unauthorized products being marketed to consumers through routine monitoring of the medical device market. 
Because the FDA has never assessed the devices, the smartwatches and smart rings may give inaccurate blood glucose measurements that “lead to errors in diabetes management, including taking the wrong dose of insulin, sulfonylureas or other medications that can rapidly lower blood glucose,” the agency said. Dosing errors can lead to “mental confusion, coma or death within hours.”
In response, the agency told consumers not to buy such devices and be aware that it has not reviewed their safety and effectiveness. The FDA is asking healthcare providers to talk to their patients about the risks of using unauthorized devices. Officials are encouraging anyone who has a problem with inaccurate blood sugar findings or adverse events linked to unauthorized wearables to file a report. 
As well as alerting consumers and physicians to the issue, the FDA is working to ensure “manufacturers, distributors and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels,” the agency said.

New GT Medical CEO Per Langoe on driving adoption of brain tumor therapy

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Per Langoe has started a new position as CEO of GT Medical Technologies, the company announced this week, replacing its founding CEO Matthew Likens.
Langoe was the co-founder and former CEO of Palette Life Sciences, which Teleflex acquired for $600 million in July 2023, and he will now lead GT Medical’s strategy to accelerate the adoption of its implantable treatment to eradicate brain tumor cells.
The company’s cancer-fighting treatment, called GammaTile, delivers radiation therapy within the cavity left in the brain after a tumor has been removed. The resorbable collagen tiles used to line the brain cavity are embedded with brachytherapy seeds that emit radiation to eliminate residual tumor cells.

The device received Food and Drug Administration clearance in 2018 for recurrent brain tumors and in 2020 for newly diagnosed malignant tumors. It is now available to patients at more than 100 of the country’s top cancer treatment institutions, including the University of Texas MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center, according to GT Medical.
The Tempe, Arizona-based company is armed with $45 million raised in a 2023 financing round led by Gilde Healthcare Partners. Existing investors include MVM Partners.
MedTech Dive spoke with Langoe about his plans for advancing the adoption of the company’s GammaTile treatment.
This interview has been edited for length and clarity. 
MEDTECH DIVE: How will GT Medical look to spread the word about this relatively new option for brain cancer patients?
PER LANGOE: GT Medical is in the same situation as many other medical device companies that are trying to change guidelines and influence standard of care. When you come with innovation, it always takes a bit of time for hospitals and health systems to start adopting that and making it a part of that standard practice. We’re going to continue to ramp up our efforts in that space.
The key way that we’re going to do it is by partnering with healthcare providers, so we are not only selling the product, but we understand how we can help them to better fit into their workflow. It’s really important to understand how we can minimize those conflicts in terms of workflow in the clinical practice.

And we’re going to make sure that we are front and center in these clinics, that we visit them perhaps more than we have done in the past to make sure that we are top of mind when they have an appropriate patient for a GammaTile treatment. 
For example, this weekend, here in Phoenix, we are arranging what we call an annual GPS meeting. It stands for GammaTile practitioner society. It’s a medical event that we sponsor, and we have users of GammaTile from all over the United States that have one and a half days of scientific interaction.
Then, of course, we’re going to continue to provide clinical evidence about the effectiveness of our product.
Why do you think your device will change the standard of care for brain cancer treatment?
Once you have resected the tumor from the brain, in some cases it’s possible to use external beam radiation. But the issue with that approach is that you need to wait several weeks before you can initiate it, because that wound you have created in the skull when you resected the tumor needs to heal. If you use GammaTile, you can introduce it immediately after you have resected the tumor, so the patient gets a high-dose radiation boost immediately following the resection. Resection is great, but in most cases, there’s going to be tumor cells left that you want to kill off with radiation. Unfortunately, some of these tumors are so aggressive that there will be fairly significant regrowth in many cases already after a few weeks.
How does the GammaTile treatment work?
Before the procedure, the radiation oncologist and the dosimetrist will calculate what the dose of radiation should be. And then we specify that to our manufacturing crew that comes up with a specific number of tiles for this particular patient. These tiles are then sent to the hospital just in time for the procedure, and the surgery crew inserts them once they have resected the tumor. It’s a fairly complicated procedure. 
You will see that for our patients, both radiation oncologists, physicists and neurosurgeons are involved. The surgeons will conduct and do the operation, and the radiation oncologist will calculate the dose and make sure that they sign off on the treatment plan and that the patient receives the tiles in time for the operation.
These treatments are customized to each and every patient that receives them.
In what other ways is the company ramping for expansion?
We have a plan to vertically integrate our manufacturing operations, bringing more of these different manufacturing steps in-house and also making sure that most steps of our supply chain are conducted here in the U.S. or North America. That’s important for our reliability of supply and that we have a steady, secure flow of product, so you’re going to see significant ramp-ups there as well.
How do you think about the size of the market you are pursuing?
When it comes to institutions that potentially could be customers, there’s a limitation to that number simply because brain tumors are fairly uncommon. Less than 1% of the population will ever develop some sort of a brain tumor. Which is really good, but it also limits the market to some extent. There might be around 200 institutions in the U.S. in total that could potentially do these procedures. And we are right now in about 100, 120 institutions.

For us, it’s not so much adding new customers — you will definitely see new customers onboarding — but it’s about improving the service to the customers that we already have. And also making sure that they have the comfort to continue to use GammaTile in more of their already existing patient cases.
What are your goals for revenue growth?
We don’t talk about revenue and all of that publicly, but our objective is to have a significant step-up in revenue this year and during the coming two years. That’s going to be our focus, to make sure that we have a steady and secure supply of products that we can deliver to customers as quickly as possible, but also to make sure that our customers are appropriately trained and have the appropriate clinical data to use our products in more and more patients.
As long as you meet those criteria, revenue will come at some point. That’s why we are so focused on making sure that we really fit into the workflow of hospitals and that we have provided the kind of clinical evidence that practitioners ask for.

Zimmer receives FDA clearance for robotic shoulder system

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Zimmer Biomet received 510(k) clearance for a shoulder feature for its Rosa surgical robot, positioning it as the first company to market for robotic-assisted shoulder replacements.
The Food and Drug Administration’s decision came earlier than expected, Evercore ISI analysts wrote in a research note. They had expected a mid-year clearance and launch.
Competitor Stryker plans to launch a shoulder feature for its Mako robot at the end of the year, CEO Kevin Lobo said in an earnings call last month.

Dive Insight:
Zimmer plans a commercial launch for the Rosa shoulder in the second half of 2024, the company said in the Thursday announcement. It’s the company’s fourth robotics application, in addition to its knee and hip platforms. 
Rosa shoulder is designed to allow surgeons to perform anatomic or reverse shoulder replacements. It’s also designed to help with precise glenoid and humeral placement, which can be critical for outcomes after surgery and the durability of the implant. 
The system also integrates with Zimmer’s surgical planning system, which allows surgeons to visualize a surgery in advance and create patient-specific guides. 
Evercore analysts posed questions about the training requirements, adoption curve for shoulder procedures, and whether the application could lead to share gains. 
Zimmer CEO Ivan Tornos said in a recent earnings call that the company expects to place about 300 Rosa robots per year, with about a third of those installations in ambulatory surgery centers. 
Stryker is also working on a shoulder application for its Mako robot, which it expects to release at the end of the year. It plans to start with reverse shoulder procedures, which make up two thirds of the shoulder market, and focus on bone preparation as a differentiating factor, RBC Capital Markets analyst Shagun Singh wrote in a research note.
Stryker has said that with Mako, it can reduce recovery time to six days instead of six weeks and make it easier to do complex procedures, added Singh.

Agilent’s McDonnell to succeed retiring CEO McMullen

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Name: Padraig McDonnell
New title: CEO-elect and chief operating officer, Agilent
Previous title: President of Agilent CrossLab Group
Scientific instruments maker Agilent Technologies has promoted Padraig McDonnell to CEO-elect and chief operating officer. He will become president and CEO in May, and will also join the company’s board of directors at that time.
McDonnell, current president of the Agilent CrossLab Group, succeeds President and CEO Mike McMullen, who is retiring, the company said Wednesday.

McDonnell has been in the instruments industry for 26 years, having begun his career with Agilent predecessor Hewlett-Packard. Agilent was spun off from Hewlett-Packard in 1999. He was named president of the CrossLab Group in 2020 and also appointed Agilent’s chief commercial officer in 2021. Before that, McDonnell was vice president and general manager of the company’s chemistries and supplies division.
“I am both honored and energized to succeed Mike and become Agilent’s next CEO,” McDonnell said in a statement. “Mike has been a great mentor to me, and I welcome his continued support.”
McMullen, who spent nearly 40 years at Agilent and Hewlett-Packard, will remain CEO and a director until May 1, and serve as an adviser to the company until his retirement on Oct. 31.
During McMullen’s nine-year tenure as CEO, the market capitalization of Agilent nearly tripled, according to the Santa Clara, California-based company.
Late last year, the company initiated a restructuring plan that included a 2% reduction of its workforce as sales slowed amid ongoing market challenges stemming from the COVID-19 pandemic. Agilent also agreed to sell its Resolution Bioscience business, which makes blood-based diagnostic tests, to Exact Sciences.
Angelica Riemann, vice president and general manager of the CrossLab Group’s services division, was named president of the group. Jonah Kirkwood, vice president of global sales, will become chief commercial officer.

3M to spin off health unit April 1

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3M plans to spin off its healthcare business Solventum on April 1, the conglomerate said Wednesday.
The company shared the date, which narrows its earlier target of the first half of 2024, alongside a registration statement that describes Solventum and the risks it could face as an independent firm.
3M expects Solventum’s adoption of its own information technology systems to be “expensive and time consuming.” Transitioning away from 3M systems could cause “temporary interruptions in business operations” and “create risks to Solventum’s relationships with customers.”

Dive Insight:
3M disclosed plans to spin off its healthcare operation in July 2022. The company initially aimed to complete the process by the end of 2023, but the separation has taken longer than anticipated.
In preparation for the spinoff, 3M has published a form to register securities for potential trading on a U.S. stock exchange. The U.S. Securities and Exchange Commission form is intended to help people make decisions about whether to invest in Solventum and, as such, it provides the closest look to date at the standalone business and the challenges it may face.
The healthcare business had total sales of $8.2 billion and net income of $1.35 billion in 2023, according to the filing, with similar marks in 2022 and 2021.
Solventum, which will include about 22,000 employees, will feature four businesses. Medsurg is the largest unit, with its portfolio of devices in wound care, intravenous site management and other areas accounting for 56% of total sales last year. Dental solutions, health information systems, and purification and filtration each accounted for 12% to 16% of total sales. 
3M believes Solventum will benefit from aging populations, the optimization of care workflows, rising use of digital technology, the shift from hospitals to ambulatory surgery centers and increasing demand for personalized care. The company sees health information systems as the fastest growing area, with a 6% to 8% growth rate forecast through 2026, and medsurg the slowest at 3% to 5%.
Solventum’s ability to match or exceed the growth rates of its end markets will depend, in part, on how it manages challenges that 3M believes it may face as a standalone company. As part of 3M, the healthcare unit has benefited from “economies of scope and scale in costs, employees, vendor relationships and customer relationships,” the company said. 
The healthcare unit relies on 3M for R&D support, information technology infrastructure and systems, and accounting and reporting systems. Solventum will create its own systems or engage third parties but the transition “could be disruptive” and hurt profitability, 3M said. As 3M moves contracts to Solventum, some partners may seek “more favorable contractual terms” such as price increases. 
3M’s filing also covers potential liabilities related to PFAS, also known as “forever chemicals,” which can be used in some medical devices such as surgical sutures and wound dressings. Animal studies suggest the chemicals, which do not break down in the environment, may affect reproduction, thyroid function, the immune system and injure the liver. 3M is exiting PFAS production by the end of 2025 and will defend Solventum against “certain liabilities” linked to the chemicals. 
However, Solventum could still face liabilities related to PFAS. Solventum will “generally be responsible for” PFAS-related liabilities linked to healthcare business conducted “at or after the separation.” There is a chance Solventum will continue to use PFAS from other suppliers after 3M stops production.
After 2025, the 3M indemnification will not apply to sales of Solventum products that contain PFAS.
In July, 3M agreed to a $10.3 billion settlement over allegations it contaminated public water supplies in the U.S. with PFAS.

Ex-Mazor exec convicted of insider trading conspiracy linked to $1.6B Medtronic deal

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A federal jury has convicted a former medtech executive in an insider trading conspiracy linked to Medtronic’s $1.6 billion acquisition of Mazor Robotics, the U.S. Attorney’s Office for the District of Minnesota said Tuesday.
The defendant, Doron Tavlin, was vice president of business development at Mazor when Medtronic stuck a deal to buy the company in 2018. According to the prosecution, Tavlin gave a friend nonpublic information about the upcoming deal.
After a nine-day trial, a federal jury found Tavlin guilty on one count of conspiracy to commit insider trading and 10 counts related to securities fraud. Tavlin is yet to be sentenced.

Dive Insight:
Tavlin and two other people were indicted for insider trading and securities fraud in July 2022. The U.S. Securities and Exchange Commission charged Tavlin and the other two men with unlawful insider trading in a civil case at the same time. 
One of the indicted men, Afshin Farahan, pleaded guilty to one count of conspiracy to engage in insider trading in August 2022. The other two people went to trial, where the jury found David Jay Gantman not guilty on one count of conspiracy to commit insider trading and six counts of securities fraud, but found the ex-Mazor executive Tavlin guilty on multiple counts.
Tavlin was present at meetings with Medtronic to discuss a potential acquisition in January 2018, Mazor told shareholders in a financial regulatory filing about the timeline of the talks. The prosecution accused Tavlin, who worked as a consultant for Medtronic before joining Mazor in 2017, of providing details of the proposed acquisition to Farahan and telling him to keep the information secret. 
Farahan bought more than $1 million of Mazor stock throughout August and September 2018, according to the prosecution, and sold the stock for a $500,000 profit the morning after the acquisition was announced. The two men were accused of agreeing to trade information for money. In October 2019, Farahan allegedly gave Tavlin a $25,000 check in exchange for information about the Mazor-Medtronic deal.
Sentencing hearings for both defendants will be scheduled at a later time.

Better Therapeutics wins breakthrough status for health app to treat liver disease

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Better Therapeutics has received breakthrough device status for a digital therapeutic designed to treat adults with advanced liver disease, the company said Tuesday.
The Food and Drug Administration awarded the designation after seeing the results of a clinical trial that linked the digital cognitive behavioral therapy (CBT) to reductions in liver fat.
Better Therapeutics won FDA authorization in Type 2 diabetes in July but, like the wider digital therapeutics sector, has struggled to allay concerns about commercialization. The company has discussed substantial doubts about its ability to continue as a going concern.

Dive Insight:
The breakthrough designation covers the use of Better Therapeutics’ platform in the treatment of adults with metabolic dysfunction-associated steatohepatitis (MASH). Studies have found behavioral changes that reduce body weight and increase physical activity can slow or reverse the buildup of fat and scarring of the liver in patients with MASH, a condition that was previously called nonalcoholic steatohepatitis.
However, lifestyle changes have proven hard to maintain. Clinicians report that they lack the “training, tools and time to effectively deliver lifestyle interventions,” and adherence to changes that help reduce body weight is a long-standing problem.
The situation is analogous to other conditions, such as substance use disorder, where behavior change is needed but challenging to facilitate and maintain because of healthcare capacity constraints. Digital CBT is designed to alleviate those constraints by using apps, rather than individuals, to deliver therapy.
Better Therapeutics’ work to establish the model in MASH advanced in October, when a paper published in the journal Gastro Hep Advances described results from a 22-subject, single-arm clinical trial. Subjects had lower liver fat after using software designed to improve dietary quality and physical activity for 90 days. The authors tracked a more than 16% reduction in the 14 subjects included in the efficacy analysis.
Last month, Better Therapeutics filed for breakthrough device designation on the strength of the data. The receipt of the designation this week positions the company to interact with FDA experts as it works to generate and submit data to support authorization in MASH.
In early November, Better Therapeutics told investors it had enough cash to fund operations into the first quarter of 2024. Changes disclosed at the end of November were expected to extend the runway enough to show “commercial traction” for the Type 2 diabetes product. 
Other companies, notably Pear Therapeutics, have struggled to commercialize digital therapeutics. Pear filed for bankruptcy in April 2023 after failing to meet revenue goals for its FDA-authorized insomnia and substance use disorder apps. Diane Gomez-Thinnes, chief commercial officer at Better Therapeutics, set out how she has approached commercialization of the diabetes app AspyreRx on an earnings call. 
“Our strategy has always been to be extremely focused, really carefully managing our resources,” Gomez-Thinnes said in November. “The work we’ve done has really been to identify where the highest concentration of high-volume targeted providers are. We expect to be these early adopters of AspyreRx.”
The company also disclosed a rebate agreement with a pharmacy benefit manager two weeks ago.

Navigating Sterilization Options for Silicone Medical Implants

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AI Oversight of Growing Interest to Health Care Executives

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QuidelOrtho fires CEO Doug Bryant

Dive Brief:

QuidelOrtho’s board fired CEO Doug Bryant on Wednesday after nearly 15 years with the company. Bryant also resigned from the company’s board. 
The diagnostics firm made the decision after a challenging quarter in which its revenue and net income declined year over year. Analysts expressed disappointment with the company’s 2024 forecasts, and QuidelOrtho’s shares lost nearly a third of their value on Feb. 14. 
The board is searching for a new CEO. Chief Commercial Officer Michael Iskra will serve as interim CEO, and Chief Operating Officer Robert Bujarski will serve as interim president.

Dive Insight:
Bryant had been CEO of Quidel since 2009. In that time, he oversaw the launches of Quidel’s Sofia and Savanna diagnostics platforms, the acquisition of Alere, and the company’s COVID-19 testing efforts, William Blair analyst Andrew Brackmann wrote in a research note.
Bryant also led the company through its $6 billion acquisition of Ortho Clinical Diagnostics in 2022, which received a chillier reception from investors. 
“His time, however, had its challenges, with sometimes overly optimistic messaging and delays on efforts such as new product launches (Savanna) or synergy capture (Ortho acquisition),” Brackmann wrote.
The analyst flagged changes QuidelOrtho made to its 2024 forecast three days after its earnings announcement, widening the range for its expected earnings per share. 
“Following last week’s 2024 guidance debacle and the ensuing calls from many investors advocating for a change in management, we understand why the board made this move,” Brackmann wrote. 
Bryant will be able to receive severance payments specified in his contract, according to a regulatory filing. 
QuidelOrtho stated the changes were made with the goal of “enhancing operational efficiency, driving revenue growth and delivering shareholder value.” The company created a new office of the CEO, which Iskra, Bujarski and CFO Joseph Busky will occupy. 
The number of board seats will decrease from 11 to 10, and Kenneth Buechler will remain chairman while the company searches for a new candidate.