Medical device cybersecurity: It’s time to get real

Medical device makers, regulators and healthcare delivery organizations are increasingly working together to strengthen cybersecurity. But are they doing enough?

[Original image courtesy of]

[Original image courtesy of]

Almost no one in the medtech industry disputes the vulnerability posed by cyberattacks. How to go about boosting security is another matter – one on which those stakeholders have recently stepped up their collaboration.

One group, the Healthcare & Public Sector Coordinating Council, thinks it has a solution: Health providers and other customers buying a connected medical device should be able to remotely access a cybersecurity bill of materials (CBOM) that would list all commercial, open-source and custom-code software. Available via remote access for customers, the CBOM would also include commercial hardware such as processers, network cards, sound cards, graphic cards and memory.

The council’s recently issued joint security plan calls for more vulnerability disclosures, notices of breaches, software and hardware upgrades and security patch availability. Companies would also need to notify customers before they end technical support for older devices.

“It’s this voluntary framework that establishes best practice for cybersecurity at a medical technology company,” council member Rob Suarez, director of product security at Becton Dickinson, told Medical Design & Outsourcing. “This joint security plan establishes the common ground which many medical device manufacturers, health IT vendors and healthcare providers agreed on.”

Some manufacturers have grumbled about providing hardware information in a CBOM, but an increasing number have pledged to publicly share vulnerability information should hackers breach one of their devices, including industry giants BD, Abbott, Siemens, Philips, Medtronic, Johnson & Johnson, Boston Scientific and Stryker.

Get the full story on our sister site Medical Design & Outsourcing. 

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Study shows catheter ablation for Afib significantly boosts quality of life

Patients who had catheter ablation for atrial fibrillation (Afib) had fewer symptoms, a significant long-term improvement in quality of life and fewer recurrences and hospitalizations than those who received drug therapy alone, according to a government-funded study.

The same study showed that catheter ablation appeared no more effective than drugs in preventing strokes, deaths, and other complications.

Get the full story on our sister site, Medical Design & Outsourcing.

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Quadriplegic Mayo scientist helps advance spine injury tech

Mayo Clinic

A team of researchers at Minnesota’s Mayo clinic, led by an individual who was left with quadriplegia from a teenage injury, are pushing the boundaries of spinal regeneration, according to a new Star Tribune report.

The group, led by spinal cord injury researcher Peter Grahn, has published findings from a study that suggests that electrical stimulation, over time, can help restore movement to paralyzed limbs.

Results from the study was published in the journal Natural Medicine, according to the report.

The researchers initially set out to replicate a similar study that showed that electrical stimulation could help individuals move paralyzed limbs, according to the Star Tribune.

In the Mayo clinic trial, investigators implanted an individual who had been left with severe spinal cord injuries due to a snowmobile accident with a Medtronic (NYSE:MDT) stimulator intended to treat pain. The device was used to stimulate the individual’s spinal cord, and over time, helped him regain the ability to move his legs.

Over time, the patient in the trial was able to sit up, stand and eventually take multiple steps with the help of a walker during stimulation, according to the Star Tribune report.

The results are joined by similar outcomes from other studies that show that there may be treatments possible for individuals with spinal injuries previously believed to be non-treatable.

“Research is suggesting that, no matter how far out the injury was, it doesn’t seem to matter,” Grahn said, according to the report.

Grahn told the Star Tribune that he had been motivated to research why spinal cord injuries are deemed “complete,” or non-recoverable, after suffering through his own life-changing spinal injury at 18.

“I still recall, early on after my injury, asking some of the medical people helping me, ‘Why does the spinal cord not recover or heart itself like a normal injury to your skin or something?’ They gave me basic answers that I could understand, but they also said it’s not totally understood. That sparked my interest,” Grahn told the paper.

Grahn was left with quadriplegia after sustaining injuries from diving into a shallow lake in 2005, just before he was set to leave to college. As an athlete, Grahn expected he would recover much of his physical capabilities as he had before with other injuries, but became depressed as the permanency of the situation set in, according to the Star Tribune report.

Only a year after the accident, Grahn enrolled in Southwest Minnesota State University with an interest in rehabilitation medicine. Mayo physician and researcher Dr. Anthony Windebank encouraged him to pursue a research program at the world-famous clinical, and Grahn eventually earned a doctorate in neuroscience and joined the Clinic in 2016, according to the report.

Research from Switzerland, released around the same time as the study from the Mayo Clinic, showed a similar case using a Medtronic stimulator, according to the Star Tribune.

Researchers in that study were able to show similar results, with patients able to regain mobility, but took the results a step further, as patients were able to walk even after the implant was shut off, according to the report.

Despite the optimistic outlook from the studies, Grahn told the Star Tribune that he tempers such hopes with the reality of his own experience, suggesting that hopes shouldn’t get too far ahead of actual results.

“I’ve been through enough of these – when these news pieces come out [promising cures] and then five years later it’s just five years down the road. I’m sensitive to the issues of giving false hope to the spinal cord community, even though hope is necessary,” Grahn told the paper.

Grahn and the research team at the Mayo Clinic are seeking additional funding to expand their work. So far, the team has worked with two individuals, though results on the second have not yet been released.

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More information out about One Discovery Square near Mayo Clinic

One Discovery Square will be located at the corner of 4th Street SW and 2nd Avenue SW in Rochester, Minn. [Rendering courtesy of Mortenson]

A new website is providing more details — including a new anchor tenant —for One Discovery Square, the roughly 90,000-square-foot biotech research, collaboration and innovation space under construction near Mayo Clinic in Rochester, Minn.

Slated to open in April 2019, the four-story building is meant to be the first step in the creation of an innovation campus that will eventually encompass 2 million square feet. Discovery Square is part of the 20-year Destination Medical Center project, in which $585 million in state and local government infrastructure funds are expected to leverage about $5 billion of private investment in Rochester.

Get the full story on our sister site Medical Design & Outsourcing. 

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Speakers you need to see at DeviceTalks Minnesota

A Google executive whose own heart problems spurred her to seek medtech innovation, a leader at Abbott who wants to drive healthcare value, the head of an upstart company seeking to transform diabetes care — those are but some of the speakers you will encounter at DeviceTalks Minnesota this June.

Read on to find out more about some of the top speakers we’ve lined up for the show. And register soon to attend.


Attend DeviceTalks Minnesota, June 4–5 in St. Paul>>

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Study: Nanoparticle shrinks tumor size by 80% in mouse model

Mayo ClinicResearchers from the Mayo Clinic have developed a type of cancer-fighting nanoparticle that is designed to shrink breast cancer tumors and prevent recurrence. In a mouse model, the therapy yielded a 70-80% reduction in tumor size and mice treated with the nanoparticles demonstrated resistance to future tumor recurrence a month later.

The nanoparticle is coated with antibodies that target the HER2 receptor – a molecule found on 40% of breast cancers. The particles target tumors by recognizing HER2 and triggering the immune cells to attack the tumor cells.

Get the full story at our sister site, Drug Delivery Business News.

Reducing cardiovascular disease risk with omega-3s

Cardiovascular disease (CVD) remains the number one killer of Americans, and by 2030, nearly 44 percent of U.S. adults will have some form of the disease. [1] It has long been recognized that consumption of omega-3 fatty acids, especially eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), can help reduce the risk of CVD. [2,3]  Indeed, joint recommendations from the American College of Cardiology (ACC) and the American Heart Association (AHA), [4] and the 2015-2020 Dietary Guidelines for Americans [5] advise dietary patterns that include fish and/or an increased intake of EPA and DHA.

Reducing CVD Risk: Recent Findings

Numerous clinical studies and meta-analyses link intake of omega-3 fatty acids with reduced risks for CVD-related events and death. [6,7,8,9,10,11,12,13]  The most comprehensive assessment of the relationship of EPA and DHA (since both are typically found in fish, fish oil, and algal oil supplements) and coronary heart disease (CHD) was recently reported in the Mayo Clinic Proceedings . [14]  Drawing from more than 3,800 studies published from 1947 to 2015, the researchers identified 18 randomized controlled trials (RCTs) and 16 prospective cohort studies (PCSs) that reported CHD outcomes (e.g., myocardial infarction, angina, sudden cardiac death and coronary death) and met other criteria. The two groups of studies included approximately 93,000 and 732,000 participants, respectively.

Using meta-analysis models, the investigators calculated summary relative risk estimates (SRREs) for CHD outcomes. For the RCT analysis, they compared the risk of CHD events for intervention-group participants consuming EPA and DHA, primarily from supplements (a few RCTs used fatty fish), compared to control-group participants who did not; for the PCS analysis, they compared the risk of CHD events associated with high vs. low intakes of EPA and DHA from all sources, including diet and supplementation. The analysis showed EPA and DHA reduced the risk for CHD events, especially in people with high serum triglycerides or LDL cholesterol (see Figure).

“The 6 percent reduced risk among RCTs, coupled with an 18 percent risk reduction in prospective cohort studies — which tend to include more real-life dietary scenarios over longer periods — tell a compelling story about the importance of EPA and DHA omega-3s for cardiovascular health,” said lead author Dominik Alexander, PhD, MSPH, Principal Epidemiologist for EpidStat, Ann Arbor, MI. [15] An accompanying editorial in Mayo Clinic Proceedings also acknowledged the importance of the findings. [16]

Scaling Up Fish Intake

On average, Americans 19 years and older consume an average of only 23 mg EPA and 63 mg DHA per day, [17]  far below the 250 mg omega-3s per day recommended in the Dietary Guidelines for Americans. [18] Moreover, about 95.7 percent of Americans have plasma omega-3s below the concentration associated with cardiovascular protection. [19] Knowing the high prevalence of this nutrient gap should encourage practitioners to advise their patients on ways to increase omega-3 intake to recommended levels.

Dietary recommendations for omega-3 intake differ among local and regional authoritative bodies. In the US, the 2015-2020 Dietary Guidelines for Americans advises consuming about 8 ounces per week of a variety of seafood to obtain an average of approximately 250 mg per day of EPA and DHA, an amount associated with reduced cardiac deaths in people with and without preexisting CVD. [20]  The joint AHA/ACC guideline for secondary prevention recommends 1 g a day of omega-3 fatty acids from fish or fish oil capsules for CVD prevention and risk reduction in patients with coronary and other atherosclerotic vascular disease. [21]  For patients who need to lower triglyceride levels, the AHA recommends 2 to 4 g of EPA and DHA per day. [22]  Based on these recommendations, physicians should advise patients to achieve the intake of omega-3s appropriate for their health needs through simple measures, such as incorporating fish rich in omega-3s as part of a heart-healthy diet and/or taking a dietary supplement that provides adequate amounts of EPA and DHA.

To learn more about omega-3s and Know Your Ω™, an educational campaign by DSM Nutritional Products, visit or visit booth #1717 at the ACP Internal Medicine Meeting in San Diego, CA March 30 – April 1. The Know Your Ω™ website has helpful tools for both physicians and patients, sharing more information on how to best recommend omega-3 EPA and DHA and incorporate them into a balanced lifestyle.



[1]Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26; 133(4):e38-e360. doi: 10.1161/CIR.0000000000000366.

[2]Mozaffarian D, Lemaitre Rn, King IB et al. Plasma phospholipid long-chain ?-3 fatty acids and total and cause-specific mortality in   older adults: a cohort study. Ann Intern Med. 2013;158:515-25. doi: 10.7326/0003-4819-158-7-201304020-00003.

[3]Krauss RM, Eckel RH, Howard B et al. AHA Dietary Guidelines: revision 2000: A statement for healthcare professionals from the  Nutrition Committee of the American Heart Association. Circulation. 2000;102:2284–99. doi: 10.1161/01.CIR.102.18.2284.

[4]Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S76-99. doi: 10.1161/01.cir.0000437740.48606.d1.

[5]U.S. Department of Health and Human Services and U.S. Department of Agriculture. 2015 – 2020 Dietary Guidelines for Americans. 8th Edition. December 2015. Available at:

[6]Delgado-Lista J, Perez-Martinez P, Lopez-Miranda J, Perez-Jimenez F. Long chain omega-3 fatty acids and cardiovascular disease: a systematic review. Br J Nutr. 2012;107(Suppl 2):S201-S213. doi: 10.1017/S0007114512001596.

[7]Kotwal S, Jun M, Sullivan D, Perkovic V, Neal B. Omega 3 fatty acids and cardiovascular outcomes: systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes. 2012;5(6):808-818. doi: 10.1161/CIRCOUTCOMES.112.966168.

[8]Kwak SM, Myung SK, Lee YJ, Seo HG; Korean Meta-analysis Study Group. Ef?cacy of omega-3 fatty acid supplements  eicosapentaenoic acid and docosahexaenoic acid) in the secondary prevention of cardiovascular disease: a meta-analysis of randomized, double-blind, placebo-controlled trials. Arch Intern Med. 2012;172(9):686-694. doi: 10.1001/archinternmed.2012.262.

[9]Rizos EC, Ntzani EE, Bika E, Kostapanos MS, Elisaf MS. Association between omega-3 fatty acid supplementation and risk of major cardiovascular disease events: a systematic review and meta-analysis. JAMA. 2012;308(10):1024-1033. doi: 10.1001/2012.jama.11374.

[10]Chen Q, Cheng LQ, Xiao TH, et al. Effects of omega-3 fatty acid for sudden cardiac death prevention in patients with cardiovascular disease: a contemporary meta-analysis of randomized, controlled trials. Cardiovasc Drugs Ther. 2011; 25(3):259-265. doi: 10.1007/s10557-011-6306-8.

[11]Wen YT, Dai JH, Gao Q. Effects of Omega-3 fatty acid on major cardiovascular events and mortality in patients with coronary heart disease: a meta-analysis of randomized controlled trials. Nutr Metab Cardiovasc Dis. 2014;24(5):470-475. doi: 10.1016/j.numecd.2013.12.004.

[12]Casula M, Soranna D, Catapano AL, Corrao G. Long-term effect of high dose omega-3 fatty acid supplementation for secondary prevention of cardiovascular outcomes: a meta-analysis of randomized, placebo controlled trials [corrected]. Atheroscler Suppl. 2013;14(2):243-251. doi: 10.1016/S1567-5688(13)70005-9.

[13]Wang C, Harris WS, Chung M, et al. n-3 Fatty acids from fish or fish-oil supplements, but not alpha-linolenic acid, benefit  cardiovascular disease outcomes in primary- and secondary prevention studies: a systematic review. Am J Clin Nutr. 2006; 84(1):5-17. Available at:

[14]Alexander DD, Miller PE, Van Elswyk ME, Kuratko CN, Bylsma LC. A Meta-Analysis of Randomized Controlled Trials and Prospective Cohort Studies of Eicosapentaenoic and Docosahexaenoic Long-Chain Omega-3 Fatty Acids and Coronary Heart Disease Risk. Mayo Clin Proc. 2017 Jan;92(1):15-29. doi: 10.1016/j.mayocp.2016.10.018. doi: 10.1016/j.mayocp.2016.10.018.

[15]Global Organization for EPA and DHA Omega-3 (GOED). Press Release. New Study Finds EPA and DHA Omega-3s Lower Risk of Coronary Heart Disease. January 3, 2017. Available at:  

[16]O’Keefe JH, Jacob D, Lavie CJ. Omega-3 Fatty Acid Therapy: The Tide Turns for a Fish Story. Mayo Clin Proc. 2017 Jan;92(1):1-3. doi: 10.1016/j.mayocp.2016.11.008.

[17]Papanikolaou Y, Brooks J, Reider C, Fulgoni VL. U.S adults are not meeting recommended levels for fish and omega-3 fatty acid intake: results of an analysis using observational data from NHANES 2003-2008. Nutrition Journal. 2014;13:31. doi: 10.1186/1475-2891-13-31. doi: 10.1186/1475-2891-13-31.

[18]U.S. Department of Health and Human Services and U.S. Department of Agriculture. 2015 – 2020 Dietary Guidelines for Americans. 8th Edition. December 2015. Available at:

[19]Murphy RA, Yu EA, Ciappio ED, Mehta S, McBurney MI. Suboptimal Plasma Long Chain n-3 Concentrations are Common among Adults in the United States, NHANES 2003–2004. Nutrients. 2015;7:10282-9. doi: 10.3390/nu7125534.

[20]U.S. Department of Health and Human Services and U.S. Department of Agriculture. 2015 – 2020 Dietary Guidelines for Americans. 8th Edition. December 2015. Available at:

[21]Smith SC Jr, Benjamin EJ, Bonow RO et al. AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients With Coronary and Other Atherosclerotic Vascular Disease: 2011 Update: A Guideline From the American Heart Association and American College of Cardiology Foundation. Circulation. 2011;124:2458-73. doi: 10.1161/CIR.0b013e318235eb4d.

[22]Kris-Etherton PM, Harris WS, Appel LJ. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation. 2002;106:2747-57. doi: 10.1161/01.CIR.0000038493.65177.94.

Mayo Clinic’s CEO attempts a do-over

Dr. John Noseworthy (l), CEO of Mayo Clinic being interviewed by Dave Lee, morning host of WCCO radio in Minneapolis at the Economic Club of Minnesota.

The CEO of Mayo Clinic, castigated recently for telling staff to prioritize care for privately insured patients over those with government insurance, said Wednesday that his remarks had been taken out of context.

Dr. John Noseworthy, added that he regrets having used the word “prioritization” in the videotaped talk he gave to employees and first reported by the Star Tribune in Minneapolis.

“I can see why it may have led to a sense that there must be a policy change, but nothing was meant,” Noseworthy told reporters following an address to the Economic Club of Minnesota. “I regret the heartache that that has caused to many patients, because our Minnesota Medicaid and our contracted Medicare patients have exactly the same access to Mayo Clinic for serious and urgent medical issues.”

Noseworthy added that he meant Mayo employees should focus on measures that will help generate savings to cover the cost care for patients whose government-provided reimbursement falls short of private payers’ rates.

“There will be continuous pressure and reduced reimbursement for the work that we do,” Noseworthy told club members. “All the healthcare providers will have to find a way to improve quality and reduce their costs.”

Noseworthy implied that Mayo and other healthcare systems that produce good outcomes should be reimbursed better for their efforts.

“You would think that in healthcare, that if you get the diagnosis right and if you do better procedures with less morbidity and mortality, if you change people’s lives, if you reduce their medications, if you support them and so on, that there would be value added to that and the reimbursement might reflect that,” he said. “That’s not currently the case. We’re working with CMS on this.”

The agency should employ risk adjustment to properly reimburse health systems that care for patients who are most likely to have the most expensive hospitalization, Noseworthy told reporters separately. That analysis should include a consideration that the patient’s home hospital could not provide the level of care that a system like Mayo could, he added.

Mayo has also been working with the Trump administration on reforming the Veterans Administration health system. It has not been asked for advice on the American Health Care Act, but Noseworthy offered it anyway.

He expressed concern about President Trump’s plan to cut funding of the National Institutes of Health by 18.3 percent, or about $5.8 billion. Noseworthy said he spoke with President Trump, emphasizing the importance of stable research funding to produce new treatments, commercialize biomedical discoveries and foster medical research careers. Under President Barack Obama, NIH gave Mayo a $142 million grant to serve as the nation’s precision medicine biobank.

He also took said Trump’s immigration policies could harm medical research and patients’ health.

“I made the point to Reince Priebus that the nation needs a global talent pool for research and medicine and that sick patients from all over the world must be able to come to America and to the Mayo Clinic for their health,” Noseworthy recalled saying to Trump’s chief of staff.

Headquartered in Rochester, Minnesota, Mayo Clinic employs 64,000 in five states. It treats 1.3 million patients per year from 50 states and 140 countries, and invests more than $900 million in research and education annually, Noseworthy noted. 

Mayo has been making strategic investments in improving quality and reducing costs since 2009, according to Noseworthy. It weathered the recession and changes wrought by the Affordable Care Act, and continues to work with CMS to demonstrate how it has been cutting costs while providing care to patients with complex medical needs.

“It’s been a wild ride, a time of unprecedented change, but these challenges present wonderful opportunities for Mayo Clinic and its staff to make organizational adjustments and to innovate,” he said.

Photo: Economic Club


Old video surfaces showing Mayo Clinic CEO prioritizing patients with private insurance

Left to right, Mayo Clinic CEO John Noseworthy, VA Under Secretary for Health Dr. David J. Shulkin and former VA Secretary James B. Peake discuss telemedicine at ATA 2016.

Looks like Paul Ryan isn’t the only one being embarrassed by the surfacing of old videos.

Mayo Clinic CEO Dr. John Noseworthy is under fire after telling employees of the Rochester, Minnesota-based health system they should “prioritize” treating patients with commercial insurance over those with Medicare or Medicaid if their conditions are the same.

In a 2016 videotaped speech to employees, of which the Star Tribune obtained a transcript, Dr. Noseworthy said,


We’re asking … if the patient has commercial insurance, or they’re Medicaid or Medicare patients and they’re equal, that we prioritize the commercial insured patients enough so … we can be financially strong at the end of the year to continue to advance, advance our mission.

Addressing employees, Dr. Noseworthy noted the Mayo Clinic had reached a
“tipping point” with a 3.7 percent increase in Medicaid patients. He cautioned that without balancing out the number of commercially insured patients, Mayo’s finances would suffer.

“If we don’t grow the commercially insured patients, we won’t have income at the end of the year to pay our staff, pay the pensions, and so on, so we’re looking for a really mild or modest change of a couple percentage points to shift that balance,” he said.

In 2016, Mayo Clinic, which sees more than 1.3 million patients annually, reported net operating income of $475 million. The same year, the health system also said it provided $629.7 million in care to individuals in need, including $83.3 million in charity care and $546.4 million that wasn’t covered by Medicaid or other programs that care for the uninsured or underinsured.

Last Friday, Dr. Noseworthy released a statement in response to the Star Tribune article:

Patient medical need will always be the primary factor in determining and setting an appointment. In an internal discussion I used the word ‘prioritized’ and I regret this has caused concerns that Mayo Clinic will not serve patients with government insurance. Nothing could be further from the truth. In fact, about half of the total services we provide are for patients who have government insurance, and we’re committed to serving those patients.

Changing demographics, aging of Americans and budgetary pressures at state and federal government pose challenges to the fiscal sustainability in healthcare today. While these discussions are uncomfortable, they are critical for us to be able to meet the needs of all our patients.”

Mayo Clinic confirmed to MedCity Dr. Noseworthy’s comment is the most up-to-date statement.

Minnesota Department of Human Services Commissioner Emily Piper told the Star Tribune the department will be examining whether Mayo violated patients’ rights or its Medicaid contracts with the state.

Dr. Noseworthy’s comments are especially ironic in a state that expanded the Medicaid program under the Affordable Care Act.

Photo: Twitter user Arizona Telemedicine 

AliveCor launches clinical app with AI function for early detection of AFib to prevent stroke

Screenshot from AliveCor Kardia Pro app for clinicians from AliveCor.

AliveCor, which has developed an FDA-cleared smartphone-enabled ECG device, has launched a clinician-facing app using artificial intelligence to pick up signs of atrial fibrillation earlier, according to a company news release. It’s an interesting development for the business because it can alert physicians to patients with an elevated risk of having a stroke.

The Kardia Pro app is for clinical use. But the goal is to analyze data from patients that includes weight, activity and blood pressure with AI to personalize the heart profiles of each patient, the news release said.


Last year, AliveCor partnered with Omron Healthcare to add Omron’s hypertension screening capabilities to AliveCor’s app.

An estimated 795,000 people suffer a stroke each year, the majority of them for the first time. If you factor in hospitalization, medications and time off of work, strokes cost the U.S. roughly $33 billion each year, according to data from the Centers for Disease Control.

AliveCor also closed a $30 million Series D round led by Omron Healthcare and Mayo Clinic. The funding will be used to speed up innovation in heart health and grow the business.

The launch of the company’s Kardia Pro app is an important milestone for AliveCor. But at a time when the hype around AI has reached a fever pitch, clinical validation will be critical to demonstrate how effective the company is at spotting early signs of life-threatening conditions such as stroke and whether these interventions improve patient outcomes.

Features Photo: Bigstock