Outro, a neuroscience-based platform, announced last week that it raised $7 million in pre-seed and seed funding.
The New York-based company helps patients discontinue psychiatric medications. Patients visit with clinicians trained in safe deprescribing and receive access to personalized tapering plans. They also gain access to compounded medication doses.
“Roughly 1 in 6 Americans take antidepressants. There are tens of millions of people on these drugs, yet no science-based way to get off safely. … Outro is the off-ramp that should have been built from the beginning. We want getting off a medication to be as supported as getting on it – arguably even more,” said Brandon Goode, co-founder and CEO of Outro.
Outro’s funding included participation from Listen Ventures, Cake Ventures, Jason Calicanis’s LAUNCH, Actions Capital, Hannah Grey Ventures, SemperVirens, Brock Recovery Group and Pave Health Ventures.
According to Listen Ventures, Outro is filling a gap in the healthcare system.
“Outro is building the infrastructure, therapeutic options, and support for deprescribing, starting with antidepressants — a model we believe will become a standard part of modern healthcare,” said Ellen Wilcox, partner at Listen Ventures, in a statement.
With the financing, Outro will expand its network of deprescribing-trained clinicians and create AI clinical decision support for deprescribing, Goode said. It will also expand beyond antidepressants into other areas. Several other drug classes require safe off-ramps, such as benzodiazepines, gabapentinoids and GLP-1s, Goode noted.
Research from Outro’s co-founder, Dr. Mark Horowitz, shows that four in five long-term antidepressant users were unable to stop their medications due to withdrawal symptoms. Horowitz helped create the hyperbolic tapering method that the company’s platform is based on. Hyperbolic tapering is a method of gradually reducing a medication dose by smaller and smaller amounts as the dose gets lower, rather than reducing it by equal increments.
“Deprescribing guidance has existed in countries like the U.K. for years,” Horowitz said in a statement. “Yet in America, where antidepressant use is widespread, tapering support is very hard to come by, so millions of patients are left without support when they are ready to come off. As someone personally impacted by a lack of tapering guidance, I am proud to be building a service to bridge this gap.”
Ultimately, Outro aims to make deprescribing a normal part of healthcare, Goode said.
“More than that, we want to empower patients with a fair opportunity to safely and sustainably transition to a life free from medication, if that’s what they want,” he said.
It’s the second time the HHS has tried to kickstart a 340B rebate program — and the second time hospitals have sued to block it, alleging rebates will threaten their financial viability.
Legislation introduced last week by Rep. Frank Pallone, D-N.J., would get rid of the arbitration process set up by the No Surprises Act entirely, the latest sign of growing interest on the Hill to reform the consumer protection law.
The case for investing in children’s health should be self-evident. As a society we have a responsibility to invest in the next generation, and few investments carry greater long-term benefit than helping children reach their healthiest possible futures.
When we diagnose and treat conditions early, we do more than improve a child’s health in the moment. We are altering the trajectory of their entire life: development of their personal confidence, resilience, mental wellbeing, learning capacity, and in many cases, also reducing decades of downstream public and private healthcare costs.
Yet, pediatric innovation remains chronically and systemically undervalued in healthcare.
That is not because the market for pediatric healthcare is small, it is because the incentives are misaligned. The cost of treating a child’s condition is incurred immediately. However, when early pediatric interventions are effective, their benefits often compound over decades.
No single stakeholder is incentivized to properly and accurately consider the full return on early pediatric interventions and support their adoption. The average tenure of a person staying on the same health plan is two to three years. As a result, private insurers are focused on cost savings that will be realized within that time frame, which for pediatric treatments especially, may only represent a small proportion of the overall benefit.
On the public insurance side, children are largely covered by Medicaid, and while pediatric health is a central tenet of Medicaid’s mission, the program is too often hamstrung by its structure. Unlike Medicare, which is entirely financed at the federal level, Medicaid is jointly financed between the federal government and each individual state. The program is often left underfunded, as its budget is subject to annual appropriations decisions by state legislators who have limited fiscal flexibility. Priorities are constantly changing, making long-term planning next to impossible for Medicaid decision makers.
That misalignment has consequences well before a new technology ever reaches a payer’s desk. When long-term pediatric outcomes are undervalued, the ripple effect moves backward through the entire innovation pipeline, shaping what gets funded, what gets studied, and what ultimately reaches patients.
Investors, wary of uncertain reimbursement and lower near-term returns, often direct capital toward adult indications with clearer paths to market. Drug and device developers may follow the same logic, deprioritize pediatric programs or skip pediatric studies. The result is a self-reinforcing cycle: limited investment leads to fewer pediatric success stories, which then reinforces the false perception that pediatric markets are too small or too risky to justify meaningful investment.
This is why pediatric innovation in healthcare must be evaluated differently.
Payers should require robust clinical evidence to make responsible coverage decisions. But the decision making framework for pediatric products should reflect the unique realities of childhood conditions: the value of early intervention, the long-term costs and consequences of undertreatment, and the potential for a therapy to alter a child’s life path before preventable challenges become permanent ones.
Policy leaders should also examine whether existing pediatric coverage pathways are actually keeping pace with modern innovation. In theory, we already have a powerful mechanism for this: the Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) benefit. Under federal law, EPSDT mandates that Medicaid-enrolled children receive all medically necessary services to correct or ameliorate important pediatric conditions, regardless of whether those services are explicitly covered in a state’s standard plan. It is a visionary policy designed to ensure that no child is left behind by the structural limitations of our healthcare system. In practice, awareness of the EPSDT benefit among Medicaid beneficiaries is low, and Medicaid plans need to do more to streamline the approval process for EPSDT-covered technologies.
Investing in pediatric care is not simply a moral imperative. It is one of the most practical long-term investments the healthcare system can make.
The question is not whether children’s health is worth the investment, that answer is self-evident. The real question is whether our healthcare ecosystem has the foresight to correct these incentive structures before another generation of children bear the cost of our delay.
Scott Xiao is the co-founder and CEO of Luminopia, a therapeutics company developing software-based interventions at the intersection of ophthalmology and neuroscience. Luminopia’s lead product is a novel FDA-cleared prescription digital therapeutic for amblyopia, the leading cause of vision loss in children, affecting approximately 1 in every 30 children. Scott founded Luminopia after leaving Harvard University at age 17, inspired by a classmate’s experience with amblyopia and the limitations of traditional treatment. He has led the company from early development through clinical validation, regulatory clearance and national commercialization, with the therapy now prescribed to more than 12,000 patients by 1,300+ providers at 600+ top eye institutes, children’s hospitals and private practices. Under his leadership, Luminopia became the first FDA-cleared virtual reality–based treatment for any medical condition. Scott has also spearheaded Luminopia’s real-world evidence strategy, including the development of the PUPiL Registry, which has been instrumental in securing both FDA label expansion and major payer coverage decisions. Scott has been recognized on Forbes 30 Under 30 list in Healthcare, MIT Technology Review Innovators Under 35, and Modern Healthcare’s 40 Under 40. Luminopia was also named one of TIME’s Best Inventions of 2023. Scott is a strong advocate for the role of technology in improving patient engagement and outcomes and is focused on expanding Luminopia’s pipeline to address additional neuro-visual conditions, including strabismus and vision loss following stroke or traumatic brain injury.
This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.
In recent years, health plans have invested heavily in improving diabetes care, with expanded access to medications, continuous glucose monitoring (CGM), and digitally enabled care management programs. Yet despite these advances, only around 40% of adults with diabetes achieve recommended glycemic targets, highlighting that important gaps remain despite substantial advances in diabetes care.
If the clinical infrastructure for diabetes care is so much better, but real-world experiences and outcomes are declining, it’s time to consider that there are other powerful factors influencing the ability of people with diabetes to effectively manage their care.
One important factor may be human connection — or the lack thereof.
This includes over 3 in 10 adults with diabetes, who often find that loneliness increases the challenges of completing daily self-care activities, including monitoring glucose levels, taking medications, and making positive choices around diet and exercise.
With emerging research suggesting that loneliness may influence how successfully individuals can manage their chronic conditions, health plans need to consider more comprehensive strategies for identifying and addressing members who could benefit most from additional education and engagement.
How loneliness provides the missing context behind diabetes outcomes
Healthcare organizations have become increasingly sophisticated in identifying clinical risk. Claims data, utilization patterns, medication adherence metrics, and biometric indicators all provide valuable insights into which members may be struggling.
However, those data points do not always explain why two individuals with similar diagnoses, treatment plans, clinical profiles, and access to clinical resources can experience dramatically different outcomes.
Loneliness may help explain part of that difference.
Unlike social isolation, which refers to limited social contact, loneliness reflects a person’s perception of connection. An individual can be surrounded by family members, coworkers, and community networks while still feeling alone in managing a chronic condition.
Loneliness can influence motivation, confidence, resilience, and engagement. Together, these factors shape diabetes self-management. Because the vast majority of diabetes care occurs outside the healthcare setting, people must make dozens of health-related decisions every day, often without immediate clinical support.
At baseline, individuals reporting loneliness demonstrated significantly poorer glycemic profiles than those who did not.
Average blood glucose levels were nearly 185 mg/dL among lonely participants compared with approximately 162 mg/dL among non-lonely participants. Glucose management indicator (GMI), an estimate of A1C derived from CGM data, was also significantly higher, while time in range was substantially lower.
In short, participants experiencing loneliness entered the program at a clear disadvantage. What happened next suggests that individuals experiencing loneliness may have the greatest opportunity to benefit from structured education, coaching, and ongoing human support.
When participants received structured diabetes education and ongoing coaching from certified diabetes care and education specialists, those experiencing loneliness demonstrated some of the most substantial improvements observed in the study.
Within three months, average glucose levels declined by more than 34 mg/dL, GMI improved by nearly one percentage point, and time in range increased by more than 17 percentage points.
While some variation occurred over the remainder of the nine-month study period, outcomes remained improved relative to baseline and narrowed many of the initial differences between lonely and non-lonely participants.
These findings suggest that loneliness is not simply a marker of poor outcomes, but also a valuable data point that can pinpoint individuals who have the most to gain from meaningful support and engagement.
The research shows a promising opportunity for health plans to connect with members who may benefit the most from more personalized engagement with experienced diabetes coaches, educators, and clinicians and therefore reduce the delta in outcomes for people with loneliness in their lives.
Recalibrating how health plans investigate poorly controlled diabetes
The study highlights the need for a more comprehensive understanding of the underlying reasons a person may be experiencing poor control of their chronic disease.
When looking at a member who is having trouble maintaining their health, the first questions usually revolve around how to connect a member with medications, CGM devices, and clinical care management resources.
But if all those are in place and the member isn’t experiencing improvement, it should trigger a deeper dive into the member’s nonclinical circumstances.
Who helps this person manage their diabetes? Do they have a caregiver, or are they trying to juggle being a caregiver for someone else? Are they socially connected outside of the home? Are they struggling with depression, anxiety, or other mental health conditions? Do they have the health literacy and confidence to participate in decision-making around their own health needs?
Asking the right questions about community support, caregiving responsibilities, emotional well-being, and the availability of trusted social networks can establish important context for a person’s outcomes — and spark conversations about social needs that might never otherwise take place.
As healthcare continues moving toward more personalized and holistic models of care, it is important to consider that “success” with diabetes care isn’t just about achieving glycemic control, but also about improving the quality of life for the whole person in multiple dimensions.
Coni Dennis DNP, RN, NE-BC, is SVP and Chief Clinical Officer at CCS, where she leads evidence-based chronic care strategies focused on improving outcomes for health plans, providers, and individuals living with chronic conditions. Prior to CCS, she spent 16 years at Humana leading clinical strategy and population health initiatives at scale, providing deep experience across care delivery, quality improvement, and value-based healthcare operations.
This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.
The annual INVEST Digital Health conference is coming up! Scheduled for October 29 in Dallas at Pegasus Park, in collaboration with Health Wildcatters, consumer influence in healthcare is the theme this year. Consumers are ordering their own diagnostics, tracking their health with wearables, accessing care directly and expecting healthcare to work more like the other services they use every day. The conference will explore how the consumer experience is impacting visits to clinicians, self-insured employers, GLP-1 drug developers and more.
In a preview of the conference, we’ve included an updated list of the speakers and the agenda. In addition to the panel discussions, attendees will also be offered a tour of BioLabs, a state-of-the-art incubator lab and office space for emerging life sciences startups. They will also get the chance to view Bridge Labs, a purpose-built, institutional-quality life sciences building, providing flexible lab and office spaces. An innovation showcase will spotlight health tech companies The conference will conclude in a networking reception in Health Wildcatters offices.
Patients’ evolving preferences and expectations have forced health systems and digital health companies to rethink how care is delivered. This panel will dive into how providers are offering patients the level of consumer-centric convenience they’ve become accustomed to in other areas of their life — and how this shift can lead to improved loyalty, adherence and outcomes.
From gut health analysis to STI check-ups to whole-body biomarker testing, patients are increasingly turning to direct-to-consumer diagnostics platforms for answers about their health. In this session, healthcare experts in this space will talk about the level of personalization, clinical rigor and consumer engagement needed in order for people to navigate this type of personal health data.
Consumers want healthcare to work like retail, with transparent pricing, home delivery, intuitive digital experiences and on-demand access. In response, drugmakers are reshaping how patients access and purchase medications by launching direct-to-consumer platforms, which could bring pharma closer to the patient than ever before. How are consumer-facing models challenging traditional healthcare distribution channels? Can these new platforms improve affordability and adherence?
Shelley Bailey, Strategic Initiatives at the Independent Pharmacy Cooperative (IPC) (moderator)
Jessin Joseph, Vice President, PBA Markets, Judi Health
The Payer’s Role in the Consumer Health Era
As healthcare becomes more and more consumer-driven, how are payers fitting into the equation? From covering direct-to-consumer digital health tools to integrating members’ wearable data to deploying voice AI for navigation and member support, payers are being pushed to go beyond traditional benefit design.
Erica Murdock, Managing Partner, Unseen Capital by Seae Ventures
Rosemary Gammon, Principal Consultant, CMR Healthcare Consultants
How Are Wearables Changing Health Behavior?
Listen to industry leaders discuss how they’re working to validate wearable data and integrate it into care delivery, as well as what they see coming down the pipeline in terms of reimbursement and regulatory pathways for wearable-driven care.
Ken Nelson, Partner, Nelson Jennings Ventures (moderator)
When Consumer Brands Enter Employers’ Benefits Stack
The line between healthcare, consumer technology and employee benefits is blurring. More and more employers are partnering with consumer brands to deliver health services that feel more like retail experiences than traditional insurance offerings. Hear benefits leaders discuss how this trend is changing access and engagement.
Jack Stockert, Managing Director, Health2047 (moderator)
Building the DTC Weight Loss Economy, One GLP-1 Script at a Time
GLP-1 drugs are one of the fastest-growing segments in digital health.This panel will explore how weight loss startups are structuring their businesses and engaging their patients to achieve health goals, as well as how they’re managing drug supply constraints and evolving beyond prescriptions into complete metabolic health offerings.
Mumbai: She was educated, professionally accomplished and financially secure. Yet when she noticed a lump in her breast, she waited eight to nine months before getting it examined. There was no pain, no obvious discomfort and, in her mind, no immediate reason to worry. By the time she sought medical attention, the cancer had progressed to stage IV and spread to her liver, lungs and bones.
The case, recalled by Dr Meenu Walia, Chairman, Medical Oncology, Max Super Speciality Hospital, Patparganj, highlights a troubling reality in breast cancer, which is delayed diagnosis is not confined to women who lack access to information or healthcare. Even educated and financially secure women can dismiss a painless lump or postpone a medical consultation while managing work, children and family responsibilities. And when that delay stretches from weeks into months, the consequences can be devastating.
The numbers reveal the larger gap. In 2024, breast cancer caused approximately 694,000 deaths globally, according to the World Health Organisation (WHO). Around 70 per cent of these deaths occurred in low- and middle-income countries, underlining the stark differences in breast cancer outcomes across healthcare systems.
WHO’s first country-wise survival estimates show five-year survival rates of 87.3 per cent in high-income countries, 88.5 per cent in the Americas and 84 per cent in the European region.
In India, five-year survival during 2017–2021 was 65.7 per cent, compared with a global median of 77.8 per cent.
The gap is therefore not only about what happens after a woman reaches a cancer centre. It is also about what happens before she gets there — whether a symptom is taken seriously, how quickly diagnosis follows and whether timely treatment is accessible.
This Breast Cancer Awareness Month, ETHealthworld examines why India continues to trail the global breast cancer survival curve, the gaps in early detection and screening, and what needs to change.
Why survival is low
Oncologists say survival outcomes are often determined well before treatment begins. Dr Ashwin K R, Head of Department of Surgical Oncology and Consultant, Surgical Oncology and Gynecological Oncology, Aster Whitefield Hospitals, says the single biggest factor behind high mortality among Indian breast cancer patients is the stage at which the disease is diagnosed.
“In India, a large share of women, especially in rural areas, arrive at stage III or IV, when the tumour is locally advanced or has already spread. Often a woman noticed the lump when it was small and treatable, but reached us months later. Low awareness, hesitation to seek care and poor access to cancer centres all play a part.”
But delayed diagnosis is not only a rural or access-related problem.
The case of the Delhi woman recalled by Dr Walia illustrates how a delay can occur even when a woman has education, financial means and access to healthcare.
When asked why she had waited several months despite noticing a lump, the patient said the lump had not caused pain or any other symptoms. By the time she was investigated, the cancer had already spread beyond the breast.
Such cases, doctors say, point to a deeper behavioural and social barrier: the tendency to treat the absence of pain as reassurance and to postpone medical attention until symptoms become disruptive.
Dr Walia says this can be particularly pronounced among women who routinely put family responsibilities ahead of their own health.
“For an Indian woman, everything else comes before her health. She thinks that taking care of herself is selfish. Her children’s exams, family functions and family duties always come first, and her health comes last. As women, we take pride in that, and we feel tremendous guilt if we put ourselves first.”
She says this pattern is reflected in cases seen routinely in clinical practice.
“That is why so many women neglect themselves. Many come to us with a lump in the breast, and when we ask why they waited so long, the answer is often, ‘My child had board exams, and I didn’t want to disrupt the household.’ These are real cases we see in our OPD almost every day.”
The consequence is that a disease that can be managed more effectively when detected early may reach a stage where treatment becomes considerably more complex.
The screening gap
Doctors agree that India needs stronger organised systems for early detection if it is to narrow the survival gap.
Countries with established screening systems have built mechanisms around regular invitations, quality-assured imaging, follow-up and referral. In the UK, women are invited for mammograms every three years from age 50, while US guidelines recommend mammography every two years from age 40.
WHO’s Global Status Report on Cancer 2026, which surveyed 130 countries, classifies India among 45 countries with no breast cancer screening programme or implementation strategy.
India does have a government population-based initiative under the national Non-Communicable Diseases (NCD) programme. The programme includes clinical breast examination by health workers for women over 30. However, coverage remains extremely low.
The National Family Health Survey (NFHS-5, 2019–21) found that only 0.9 per cent of women aged 30 to 49 had ever undergone a breast examination for cancer.
The challenge, however, is not simply about introducing mammography nationwide.
According to Dr Ashwin, India would first need to build the healthcare capacity required to support a quality screening programme from detection through treatment.
“This is very different from a quality-assured mammography programme with invitations, repeat screening and reliable follow-up, like those in many Western countries. Scaling mammography to India’s size would need thousands of machines, trained radiologists and quality control. Most importantly, it would need the capacity to carry out imaging, biopsy, pathology and treatment for every abnormal result.”
There is also an age-related challenge, he points out.
“There is also an age mismatch: mammography works best for women over 50, while many Indian women develop the disease younger.”
That makes the question of what constitutes an effective screening strategy for India more complex than simply replicating programmes designed for Western populations.
Dr Indoo Ammbulkar, Director and Head of Department, Medical Oncology, HCG Cancer Hospital, Mumbai, says the country’s enormous variation in healthcare access is another major barrier.
“India has a very large and diverse population, with major differences in healthcare access between urban and rural areas. This makes implementing a uniform nationwide screening programme challenging. We also need trained healthcare workers at villages, towns and at community levels as well as diagnostic facilities and systems for follow-up.”
In other words, screening cannot work as a stand-alone intervention. Detecting an abnormality is only the first step. Women must also be able to access diagnostic imaging, biopsy, pathology, specialist consultation and treatment without falling out of the system.
Beyond screening: building a prevention mindset
For doctors, closing India’s breast cancer survival gap will therefore require more than increasing the number of machines or launching another awareness campaign. It will require women to seek medical attention earlier, healthcare workers to identify symptoms and refer patients promptly, and health systems to ensure that women who enter the diagnostic pathway are able to complete it.
Dr Walia believes the first hurdle is not necessarily infrastructure, but intent.
“The first thing that stands in the way is intent. There has to be a higher intent to push preventive health forward. We need more organised efforts and need to start valuing human life more.”
That intent will need to translate into sustained public-health action — from improving awareness of breast symptoms and encouraging timely consultations to strengthening screening where appropriate and ensuring that abnormal findings do not disappear into an overstretched healthcare system.
For India, the survival gap is ultimately not just a cancer-care challenge. It is a challenge of timing.
A woman who reaches treatment when the disease is still localised has a very different set of options from one who arrives after the cancer has spread. The difference between the two can begin with something as simple as taking a painless lump seriously.
India has made significant advances in cancer treatment. The next challenge is ensuring that more women reach that treatment early enough for those advances to make a difference.
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New Delhi: Amid growing calls for transparency in healthcare costs, the Ministry of Health and Family Welfare has asked all states and Union Territories (UTs) to ensure that clinical establishments prominently display the rates they charge for their services and facilities.
In a letter to the Chief Secretaries of all states and UTs, Union Health Secretary Punya Salila Srivastava, called for a review of compliance with applicable regulatory provisions and appropriate measures to ensure that information on healthcare service charges is clearly visible and easily accessible to patients and their attendants.
Srivastava noted that the conspicuous display of rates would help patients and their families understand the likely cost of treatment, make informed healthcare decisions and plan their medical expenditure.
The letter refers to the Clinical Establishments (Registration and Regulation) Act, 2010, and the Clinical Establishments (Central Government) Rules, 2012, which provide a regulatory framework for Clinical Establishments.
According to the ministry, “Under the Rules, Clinical Establishments in States and UTs where the Act is applicable are required to display the rates charged for each type of service provided and facilities available at a conspicuous place, in the local language as well as in English, for the benefit of patients and their attendants.”
In States and UTs where the Act is not applicable, Clinical Establishments are regulated under the respective State/UT frameworks, several of which also contain provisions relating to the display of rates for healthcare services and facilities.
Recognising that health is a State subject and that implementation and enforcement of the applicable regulatory provisions rest with the respective States and UTs, the Union Health Secretary has called upon the Chief Secretaries to ensure effective compliance through the authorities concerned.
The letter also places particular emphasis on transparency in healthcare pricing for international patients.
States and UTs have been asked to encourage the prominent display, wherever applicable, of package rates offered to foreign patients travelling to India on Medical or Ayush Visas.
This would enable international patients to make informed choices, help minimise pricing and billing-related grievances and further strengthen India’s position as a trusted destination for medical and Ayush care, the ministry added.
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Robotics are increasingly being incorporated into today’s complex surgeries, and their capabilities are quickly expanding as they take on new tasks and higher levels of autonomy. The FDA recently published draft guidance on pre-market testing for robotically-assisted surgical devices, raising timely discussion around whether hospital infrastructures are capable of supporting increasingly complex systems.
It describes how robotic surgical devices should be tested prior to clinical use, covering everything from the robot’s movements to the design of its software, its reliability and accuracy, its cybersecurity measures, safety and sterility, how it visualizes patient images, and how it interfaces with the surgical team. The guidance is aimed at manufacturers and is currently nonbinding; it is open for comment until November 24.
As surgical technology becomes increasingly connected, the FDA’s guidance asks manufacturers to consider how different software functions within a single operating room interact. This raises a critical question for hospitals: as surgical robots become more sophisticated, what must the operating rooms around them have to successfully integrate the new technology?
Dr. Nadine Hachach-Haram, a surgeon and the founder and CEO of Proximie, argues that the answer lies in understanding the operating room as a connected clinical ecosystem.
“What stands out to me in the FDA’s guidance is that it treats the robot as part of a much wider clinical system,” Hachach-Haram said. “It looks beyond the device itself to the software, connectivity, training and the environment in which it will actually be used. That matters because, as a surgeon, you quickly see that even very advanced technology has to work within the reality of the operating room.”
Proximie, headquartered in London, is a health technology company whose platform is designed to connect operating room devices and support intra-operative video and data capture. The company says its software is used by more than 700 hospitals worldwide.
Hachach-Haram asserts that it’s important for manufacturers to assess whether the addition of more complex capabilities may impact the performance of a new robotic device, a consideration which the FDA guidance also underscores.
“A great robot should still be a great robot once the video and data sit alongside it, not a lesser robot with a video system attached,” said Hachach-Haram.
“Failure to maintain cybersecurity can result in risks such as compromised device functionality, loss of device availability, loss of data (medical or personal) availability and/or integrity, or exposure of other connected devices or networks to security threats. This in turn may have the potential to result in patient injury.”
Human factors are another focus, with the FDA emphasizing that testing should be conducted in realistic contexts to accurately assess performance within real-world operating room conditions.
As surgical robots continue to evolve, the guidance asks manufacturers to prove that these new technologies work smoothly as part of today’s complex human-and-machine operating team.
Mumbai: Obesity was found to be the leading threat to global public health in terms of avoidable years of healthy life lost, as per The Lancet Commission on 21st Century Global Threats to Health.
According to the commission, obesity could account for 23.1 billion cumulative amenable disability-adjusted life years (DALYs) between 2025 and 2100.
The figure is the highest of the 17 catastrophic threats to human health and survival assessed by the Lancet Commission, which include the malicious use of artificial intelligence (AI) and nuclear conflict.
The study draws on new risk analysis from the Institute for Health Metrics and Evaluation covering 204 countries and territories.
The Commission describes the obesity burden as growing and forecast to compound over time. Obesity’s avoidable burden was found to be several times higher than that of climate change (1.89 billion DALYs), pandemics (2.39 billion DALYs) and antimicrobial resistance (3.44 billion DALYs).
Seeking comment on the Lancet Commission’s findings, Mumbai-based diabetologist Dr Rajiv Kovil told ETHealthworld that the findings should be a particular concern for India, where obesity often manifests differently and BMI alone may fail to capture the associated health risk
“India faces a particularly dangerous form of obesity: more visceral fat, less muscle and metabolic disease at lower BMIs. Many Indians may look thin but are metabolically obese. BMI alone cannot capture this risk. With over 100 million Indians living with diabetes, obesity is driving an epidemic of diabetes, fatty liver and cardiovascular disease. India’s biggest threat is not just expanding waistlines, but deteriorating metabolic health, often at younger ages.”
The Commission recommended governments to invest in long-term innovations such as oral obesity medicines, through public-private partnerships to tackle the growing threat of obesity.
Dr Kovil said that while GLP-1 drugs have revolutionised obesity treatment, they alone cannot solve India’s metabolic crisis.
He added, “Alongside GLP-1 therapy, adequate protein, resistance exercise and muscle preservation are essential. Medicines can treat the biology of obesity, but intelligent policies must prevent it.”
Speaking on the finding, Dr Anoop Misra, Chairman at Fortis CDOC Hospital for Diabetes and Allied Sciences told ETHealthworld that India must act now to to strengthen prevention.
He said, “India urgently needs stronger preventive policies, early screening, environmental action and equitable healthcare. Failure to act now will impose an enormous health and economic burden on future generations.”
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