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Medical Innovation Exchange

Elise Reuter

GE Healthcare closes $1.45B acquisition of BK Medical

GE Healthcare will expand its ultrasound business into the operating room. The company closed its planned $1.45 billion acquisition of surgical visualization company BK Medical.
BK Medical, which has headquarters in Boston and Copenhagen, currently has more than 650 employees. It has been experiencing double-digit revenue growth, the companies said in a news release. 
While GE Healthcare currently uses ultrasound for preoperative and postoperative visualization, the acquisition would also give it the ability to use ultrasound in real-time during a procedure, to help surgeons make decisions. BK Medical would also be able to reach new customers in new markets as part of GE. 
BK Medical CEO Brooks West will continue to lead the company, and it will operate as part of GE Healthcare’s $3 billion ultrasound business. 
 “We have been on a journey to change the standard of care for surgery by making it possible for surgeons to make critical decisions in the operating room using real-time advanced visualization, allowing for better care, faster surgeries and reduced complications,” West said in a news release. “Together with GE this journey will continue, and we can look forward to making a greater impact in healthcare around the world.”
GE is currently in the process of spinning out its healthcare division as part of a broader restructuring. Last year, the division brought in $18 billion in revenue. GE Healthcare would become a separate, publicly traded company in 2023, with GE keeping a 20% stake.
Photo: crazydiva, Getty Images

Medtronic hit with FDA warning letter for diabetes devices

Medtronic recently expanded a recall of its MiniMed 600 series insulin pumps due to broken retainer rings.
The Food and Drug Administration slapped Medtronic with a warning letter related to inadequate medical device quality requirements for its diabetes business. Specifically, the warning letter refers to issues with risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events.
In July, the FDA inspected Medtronic’s Northridge facility, the headquarters for its diabetes business, after a recall of Medtronic’s MiniMed 600 series insulin pumps.
Medtronic disclosed the warning letter in a Wednesday news release, and said it would implement corrective actions and process improvements in response. However, the company shared few details on what those actions would entail.
“We are committed to fully resolving all observations as effectively and quickly as possible, Sean Salmon, president of Medtronic’s diabetes business, said in a news release. “Nothing is more important to us than providing the highest quality products to people living with diabetes.”
Recalls of the insulin pumps began in 2019, when broken retainer rings resulted in patients receiving the incorrect dose of insulin. Medtronic recently expanded the recall to include all of its MiniMed 600 series insulin pumps, to replace the retainer ring with a more durable version.
Separately, Medtronic also recalled the remote controller for its MiniMed 508 and Paradigm pumps for potential cybersecurity risks.
Medtronic’s stock fell 6% on the news Wednesday, while competitors Tandem and Insulet saw their stocks rise 10% and 5% respectively.
 In a filing, Medtronic said it expects its diabetes business will be affected, with a revenue decrease in the high-single digits for the third quarter, and in the mid-single digits for fiscal year 2022. The company does not expect to change its overall earnings guidance for next year, but could potentially see a slight impact to its revenue growth in 2023.

Philips gets FDA clearance for two acute patient monitors 

An IntelliVue MX850 monitor displays  patient’s vitals. Philips recently received FDA 510(k) clearance for its IntelliVue MX750 and MX850 devices. Photo credit: Philips
A year after they were given an emergency nod to be used during the pandemic, two of Royal Philips’ newest patient monitors now are cleared by the Food and Drug Administration. The agency recently granted 510(k) clearance to Philips’ IntelliVue MX750 and MX850, which are designed to provide real-time information on a patient’s vitals and support remote monitoring in a hospital setting.
The FDA initially gave Philips an emergency use authorization for the devices in April of last year, shortly after the start of the Covid-19 pandemic. Given that the devices could be used to remotely monitor hospitalized patients, the intent was to use them to watch hospitalized Covid-19 patients’ vitals without exposing healthcare workers to the virus during a time where masks and other protective equipment were scarce.
Philips says the devices feed encrypted patient data into a hospital’s EMR, offering a real-time view of their conditions. They can connect to devices, such as IV pumps, anesthesia machines and ventilators. The monitors can also support clinical decision support tools, such as one that Philips developed to show changes in vital signs and provide context about a patient’s condition.
The FDA clearance just includes the two monitors, but add-on display screens and a module server rack were also included in the emergency use authorization. The full system has been used in Europe since it received a CE mark in 2019.

Ascension Ventures leads $77M fundraise in wearable for tremors

Cala’s Trio device is FDA cleared to be used by patients with essential tremor to manage their symptoms. Photo credit: Cala Health
Ascension Ventures recently led a $77 million funding round in Cala Health, a startup with a wearable device for essential tremor. The Burlingame, Calif.-based company makes a wrist-based device that uses electrical stimulation to temporarily relieve tremor symptoms.
Essential tremor, characterized by the involuntary shaking of the hands, affects about 7 million people in the U.S.  A few treatment options currently exist, such as beta blockers, but they’re not always well tolerated.
Cala plans to use the funds to expand to additional indications and seek broader coverage of its device.
“We are honored to have Ascension Ventures join us on our journey to realize the power of bioelectronic medicine,” Cala CEO Renee Ryan said in a news release. “This investment allows us to build upon our strong foundation in treating essential tremor and develop new therapies to help more patients living with chronic disease. Our team is dedicated to closing the massive gap in patient care.”
Cala was founded in 2014 by engineer and neuroscientist Kate Rosenbluth. Ryan, a former Johnson & Johnson Innovation venture capitalist, later joined as its CEO.
The startup first received de novo FDA clearance in 2018 to aid in tremor relief, and is now looking to expand to additional indications. It received a breakthrough device designation last year to treat action tremors in adults with Parkinson’s disease.
At the same time, it’s also looking to build out relationships with payers, as it seeks reimbursement options in Medicare, commercial plans, and “payviders.” Cala recently shared the results of a post-market analysis that it plans to use to win over payers, showing a reduction in tremor strength for people that used the device more often.

CMS scraps coverage rule for breakthrough devices

Medicare is no longer required to cover “breakthrough” devices after they are cleared or approved by the Food and Drug Administration.  The Centers for Medicare and Medicaid Services rescinded a final rule on Friday, citing safety concerns.
“Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries,” CMS Administrator Chiquita Brooks-LaSure said in a news release. “The Medicare program needs to implement policies that balance access and appropriate safeguards.”
The Medicare Coverage of Innovative Technology rule has been in limbo for months, since it was first published in the final days of the previous administration. Medicare would have covered devices for up to four years that had received a breakthrough designation, and subsequently received marketing authorization from the FDA.
The FDA’s breakthrough devices program is intended to speed up the review of devices that provide more effective treatment or diagnosis for life-threatening or debilitating health conditions. It applies to a substantial number of devices: nearly 300 as of last year, according to MedTech Dive. 
Medical device companies, especially those with cleared breakthrough devices, were proponents of CMS’ rule. However, physician and insurance groups were more skeptical, noting that patients covered by Medicare are often underrepresented in clinical trials, and the requirement could remove some protections for patients.
After bumping back the implementation date to December, CMS had talked about scrapping the final rule. On Friday, that decision became final.
The agency said that the kinds of clinical studies needed for FDA market authorization might not consider the specific needs of Medicare patients, including the differences in clinical profiles or complex medical conditions.
“Under the rule we are repealing, CMS may have covered devices without adequate evidence to demonstrate that the device would be reasonable and necessary to diagnose or treat the Medicare population for particular medical conditions,” Dr. Lee Fleisher, CMS chief medical officer and director for the Center for Clinical Standards and Quality, said in a news release.
For now, device manufacturers will still need to get local coverage determinations or a national coverage determination to be covered by Medicare. However, CMS is leaving the door open for creating new policies to expedite this process.
The agency said it plans to work with the FDA, the Agency for Healthcare Research and Quality, and medical device manufacturers, to develop a process to more quickly cover innovative devices that benefit Medicare patients. It plans to hold stakeholder meetings next year as it drafts future policies.
Photo credit: zimmytws, Getty Images

GE plans to spin out healthcare business in 2023

As part of a broader restructuring, General Electric plans to spin out its healthcare segment in 2023.
GE Healthcare, which includes medical devices, software and diagnostics, will become a separate, publicly traded entity. GE would keep a 20% stake in the company.
In a press release announcing the spin-out, GE said it would become a “pure-play company at the center of precision health.”
By spinning off two of its segments into new companies, the conglomerate hopes its efforts will be more focused, and that the new entities would have more flexibility to pursue growth opportunities. GE Healthcare would be headed up by Peter Arduini, who was tapped to become the CEO of the division starting in January of next year.
GE CEO and Chairman Larry Culp said in a news release that the changes would allow GE to “realize the full potential of each of our businesses.”
Last year, GE’s healthcare division brought in $18 billion in revenue. It develops MRI, CT scan, X-ray machines and other diagnostic devices. It also sells software to be used for clinical monitoring, ICU management and anesthesia delivery.
As with other medical device companies, the pandemic had an effect on GE’s business. It saw increased demand for ventilators, x-ray machines, monitoring solutions and other products related to the pandemic. At the same time, it saw reduced demand for other products, such as MRI machines and contrast agents.
In September, the company bought BK Medical, expanding its ultrasound business into the operating room.
The spinoff is part of a broader restructuring by GE as it looks to turn around its business and reduce its debt. In 2019 GE sold its pharmaceutical business for $21.4 billion to Danaher. The company also plans to spin out its energy business in 2024, leaving GE’s core business focused on aviation.
Photo Credit: Scott Olson/Getty Images

Philips builds on cardiac monitoring with Cardiologs acquisition

Royal Philips is adding another remote-monitoring platform to its portfolio with its planned acquisition of Cardiologs.
The Paris-based company uses ECG data to detect potential cardiac arrhythmias. While there are a plethora of companies looking to tap into ECG data, including KardiaMobile’s consumer-facing devices and the Apple Watch, Cardiologs sets itself apart with a device-agnostic platform.
Cardiologists can upload ECG information to Cardiologs’ cloud platform from a variety of compatible devices, from Holter monitors to smartwatches and ECG patches. The company’s software platform is FDA-cleared and CE-marked to screen for atrial fibrillation and other arrhythmias as a physician aid, not as a standalone diagnostic tool.
The companies have not disclosed the terms of the deal, which is expected to close in the coming months. Cardiologs’ 70 employees, largely engineers and data scientists, will be able to join Philips and work with its R&D lab in Paris. Yann Fleureau, Cardiologs’ CEO and co-founder, emphasized that the company would continue to work with third-party vendors after the acquisition.
Roy Jakobs, chief business leader of connected care at Philips, said in a news release that the deal would add to Philips’ growing portfolio of cardiac solutions for hospital and ambulatory settings.
“Philips’ global footprint can accelerate the availability of Cardiologs’ technology to patients all over the world and further deliver on the quadruple aim of an improved patient care experience, better health outcomes, improved staff experience, and lower cost of care,” he said.
Philips made another significant remote monitoring acquisition in late 2020, when it bought BioTelemetry for $2.8 billion. Philips said the deal would add cardiac diagnostics and monitoring to its existing capabilities.
Other medical technology companies have also bought into arrhythmia-detecting devices recently. At the beginning of the year, Boston Scientific bought Preventice Solutions, which makes Holter monitors and other cardiac monitoring devices. Baxter also bought Hillrom for $10.5 billion, which makes ECG monitors and software.
Photo: BrianAJackson, Getty Images

FDA’s proposal for over-the-counter hearing aids draws mixed response from manufacturers 

Soon, people may be able to buy hearing aids without needing to go through a hearing exam or fitting. The Food and Drug Administration issued a proposed rule on Tuesday that would allow adults to buy the devices over-the-counter, with the goal of making them more affordable and accessible.
With hearing aids costing an average of $2,500 a pop, the FDA’s announcement was welcome news for the millions of people who experience hearing loss. For manufacturers, though, it drew a mixed response.
Currently, six companies make the majority of hearing aids. One of the largest, Switzerland-based Sonova, hasn’t commented directly on the FDA’s rulemaking, but bought headphone-maker Sennheiser’s consumer division in May. Another consumer electronics company, Bose, released an FDA-cleared, self-fitting hearing aid earlier this year.
Starkey Hearing Technologies, a large U.S.-based manufacturer, has been more vocal with its concerns about the proposed changes.
“We support efforts to increase the accessibility and affordability of hearing aids, but we believe better hearing is best achieved through the hearing professional,” CEO Brandon Sawalich wrote in an emailed statement.
He also shared some specific concerns with the proposed rule, saying the recommended output limits should be reduced to 110 decibels, and that there should be a limit on max gain, or a hearing aid’s amplification.
“We are still analyzing the entirety of the proposed regulations on OTC hearing aids from the FDA, however, in addition to not involving the hearing professional, some initial concerns exist around patient safety and satisfaction,” he wrote.
On the other hand, Audicus, a newer entrant that uses a free online hearing test, was more vocally supportive of the proposed rule. It doesn’t make its own hearing aids, but buys them from manufacturers and resells them at a cheaper price than most hearing clinics.
“We welcome the FDA’s proposed rule to create a class of OTC hearing aids and see it as a milestone towards greater access,” CEO Patrick Freuler wrote in an email. “It will only allow us to further reach those in need of hearing solutions, and deliver life-changing devices to them at a fraction of the cost of  traditional channels.”
The specificsThe FDA’s proposed rule would only apply to hearing aids for adults with mild- to moderate- hearing loss. For children, a medical evaluation would still be required before using a hearing aid.
Devices would be limited to a maximum output of 115 decibels, or 120 dB if the device has adjustable volume. The FDA doesn’t plan to limit max gain, saying it would “unduly constrain” the design of devices, and that maximum output levels should be enough for users’ safety.
The agency is also looking at other performance requirements, such as distortion, noise and latency limits.
The idea of over-the-counter hearing aids has been in the works for years. Back in 2015, a report by the President’s Council of Advisors on Science and Technology recommended creating a class of over-the-counter hearing aids, noting that only a fraction of older adults with hearing loss use them. Two years later, Congress passed the Over-the-Counter Hearing Aid Act, creating this class of devices.
The FDA is expected to finalize the rule next year. The Hearing Loss Association of America (HLAA), a consumer advocacy group that supported the legislation, said it expects it will take a year or more for over-the-counter hearing aids to come to market.
“We hope that many adults who qualify for these devices are encouraged to take that important step toward good hearing health,” HLAA Executive Director Barbara Kelley wrote in a news release.
The rule change would effectively remove the requirement that people would need a medical evaluation to buy a hearing aid, and  regulate hearing aids for severe hearing loss or for children as prescription devices.
Photo credit: PIKSEL, Getty Images

Dexcom taps Garmin for first real-time API integration 

Garmin is one of the first companies to integrate with Dexcom’s G6 CGM data after its real-time APIs were cleared by the FDA. Photo Credit: Dexcom
After getting the green light from the FDA this summer to let third parties access its CGM data, Dexcom is bringing on its first partner. The company announced an API integration with Garmin, which makes a wide range of wearables, including several smartwatches designed for serious athletes.
The integration would let people view their blood glucose levels and trends on their smartwatch or one of Garmin’s cycling computers. They can see a three-hour history of their blood glucose levels and where their numbers are heading, as well as performance data from their workouts.
This is helpful as exercise can affect blood sugar levels, making it important to check them before and after working out.
“Users can not only see which way their glucose levels are trending without having to take their phone out, but can even do so while working out, when glucose levels have the potential to fluctuate quickly,” Dan Bartel, Garmin’s vice president of worldwide sales, said in a news release.
Currently, Dexcom’s G6 CGM is FDA cleared for real-time API integrations. The company is working on the newest rendition of its CGM, the G7. Earlier this year, it submitted an application for a CE Mark in Europe and began gathering data from a pivotal study in the U.S., Dexcom COO Quentin Blackford said in a July earnings call. 
As for other planned API integrations, Dexcom didn’t disclose any additional partners. However, when the company first got FDA clearance, it announced both Garmin and Livongo as early partners. Dexcom had been working closely with Livongo since early 2020, when the companies struck a partnership to integrate data from Dexcom’s CGM with Livongo’s platform for diabetes management.
Blackford also said two other digital health platforms for managing chronic conditions are using its real-time connectivity solutions: Welldoc and UnitedHealthcare’s Level2.

INVEST DH Pitch Perfect winner spotlight: Sonavi Labs founder builds on father’s legacy with tech to detect respiratory diseases

Ellington West had been leading a national sales team for a large healthcare company when she got a call from her father. A professor at Johns Hopkins known for inventing the microphones we use today, he had built a device to detect respiratory conditions as part of a Gates Foundation challenge to reduce pediatric mortality from pneumonia.
“My dad said, ‘this device is going to live and die on a shelf at Hopkins unless we did something about it,’” she said. “When you know that there’s this problem, one child dying every 36 seconds, and that you are aware there’s a tool that can help impact those numbers, you can’t not respond. There’s a responsibility that comes with that.”
Sonavi Labs CEO Ellington West holds the company’s smart stethoscope device.
She set out with her co-founder, who had worked as a research assistant on the project, to found Sonavi Labs in 2017. The Baltimore-based startup makes smart stethoscopes that can be used at home or in the clinic, and in the longer term, the company hopes to get FDA clearance to use it to detect respiratory conditions.
The problem Sonavi Labs hopes to solve is massive. Pneumonia is the largest infectious cause of death in children worldwide, according to the World Health Organization. Although the device can be used for adults and children, Sonavi has started with a focus on pediatrics.
“The pediatric device market is so underserved, when you really think about innovation,” West said. “It takes so much more effort and attention and compassion to ensure these devices are commercialized and do reach the patient. From a capital standpoint, it’s an underfunded space. … It really requires specialized hospitals and pediatricians and all of these organizations to come together to see change happen.”
Right now, Sonavi has 510(k) clearance for its Feelix noise-cancelling stethoscope. It recently made a FDA submission to seek breakthrough designation for its device to detect pneumonia. In the future, it plans to expand to other respiratory conditions, such as asthma and COPD.
Judges picked Sonavi Labs as the winner of MedCity INVEST’s Pitch Perfect competition for home health.
“Sonavi Labs has developed a critical solution, especially in today’s unprecedented times,” Lily Huang, a principal at NEA, wrote in an email. “Ellington delivered a strong message on the potential wide-reaching impact of Feelix.”
Nickolas Mark, a managing director and partner at Intermountain Ventures, congratulated the company for its focus on transforming the detection and management of respiratory diseases.
To date, Sonavi has raised a total of $6.5 million, including $3.5 million from seed investors, and another $3 million in grants.
Photo credit: Jackie Niam, Getty Images