The FDA has approved software that will make it easier for healthcare staff to take echocardiograms.
The technology, developed by San Francisco-based artificial intelligence startup Caption Health, will help more hospitals take ultrasound pictures of the heart, a skill that is usually limited.
Echocardiograms are one of the most widely used tools to help in the diagnosis and treatment of heart disease. Killing around 647,000 people every year, heart disease is the leading cause of death in the United States.
Deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Centre for Devices and Radiological health praised the move.
He said: “Today’s marketing authorization enables medical professionals who may not be experts in ultrasonography, such as a registered nurse in a family care clinic or others, to use this tool.
“This is especially important because it demonstrates the potential for artificial intelligence and machine learning technologies to increase access to safe and effective cardiac diagnostics that can be life-saving for patients.”
The new software, called Caption Guidance, will help doctors and nurses to carry out the echocardiogram procedure before a trained cardiologist reviews the images.
It is the first software authorized to guide users through ultrasound images of the heart.
Caption Guidance was developed using machine learning, which trained the software to establish a difference between acceptable and unacceptable echocardiogram image quality.
The knowledge, equipped with an interactive AI user face, provides guidance to untrained healthcare professionals on how to maneuver the ultrasound probe for the best results. The software provides real-time feedback, can auto-capture video clips and can select and automatically save the best clip for review.
Caption Guidance is currently used with an FDA-cleared ultrasound system developed by Teratech Corporation. However, it has the potential to be rolled out across more systems.
Studies carried out by the FDA to test the technology proved 50 trained sonographers could obtain similar images both with and without the help of the Caption Guidance software.
Following this, eight registered nurses, who are not experts in sonography, used the software to obtain images. All images captured were ‘of diagnostic quality’, according to five cardiologists who assessed the work.
The results showed that Caption Guidance would enable registered nurses to successfully acquire echocardiography images and videos.
The software was reviewed through the De Novo premarket pathway, created by the FDA to regulate low to moderate risk devices
Captions CEO Andy Page said in a statement: “No patient should have to forgo a potentially lifesaving cardiac ultrasound. Through the power of artificial intelligence, Caption Guidance will provide patients with unprecedented access to ultrasound when and where they need it most.”
The FDA has said it will soon be sharing more information on the role of artificial intelligence in the healthcare industry.
Along with the authorization, the FDA is working to release special controls for devices of this type which will include requirements related to labeling and performance testing.
The move will create a new regulatory classification so that subsequent similar devices could go through the administration’s 510(k) premarket process. This would allow companies developing new devices to obtain authorization by demonstrating their similarities to technology already on the market.
In a statement, the FDA said it was ‘dedicated to ensuring medical device regulation keeps pace with technological advancements’ and will be hosting a workshop titled “Evolving Role of Artificial Intelligence (AI) in Radiological Imaging”.
It also wants to discuss emerging AI in radiological imaging to focus on best practices for the validation of AI-automated radiological imaging software.
NRC Health was hit with a ransomware attack Feb. 11 and it still working to restore its systems and services.
The company, which works with 75% of the 200 largest U.S. hospital chains, administers patient survey tools to hospitals.
The cyberattack was first reported by CNBC’s Chrissy Farr on Thursday.
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NRC Health works with 9,000 healthcare organizations, including Adventist Health, Jefferson Health, Cedars Sinai, Phoenix Children’s Hospital, Ochsner, and Providence Health, according to the company’s website. NRC Health collects data from more than 25 million healthcare consumers a year across the U.S. and Canada.
In a statement provided to FierceHealthcare, Paul Cooper, Chief Information Officer at NRC Health, said on Feb. 11 the company experienced a ransomware attack on certain computer systems and immediately shut down its “entire environment,” including client-facing reporting portals, to contain the issue.
“We also immediately launched an investigation with the assistance of a leading forensic investigation firm to determine the nature and scope of the incident and notified the FBI,” Cooper said.
Since last week’s attack, NRC Health has made “significant progress” in restoration to its systems and services to its customers.
The company anticipates full restoration in the coming days, according to Cooper.
Cooper said in his statement that there is no evidence, to date, of unauthorized access to or acquisition of any data from NRC Health’s systems, including protected health information or other confidential information.
The company started notifying its hospital customers with an email alerting them to the attack, according to CNBC.
Despite the company’s assurances, some hospitals notified of the cyberattack have raised concerns that private patient data was accessed, according to sources who spoke with CNBC’s Farr.
One health system CEO, who requested anonymity, said that they were concerned about hackers having access to confidential information about their hospital including its market share, Farr reported.
Measures from patient satisfaction surveys are not only used for patient loyalty, but the majority of senior health care executives have compensation tied to patient satisfaction scores. Hospital reimbursement is also being directly affected by inpatient satisfaction ratings as a part of the Centers for Medicare and Medicaid Services (CMS) value-based purchasing program and private payer initiatives, according to the American Medical Association Journal of Ethics.
“With NRC’s systems shut down, one chief information officer at a hospital said that it’s been a ‘major source of irritation internally,’ because the systems are used to determine how much its physicians are getting paid,” Farr reported. The executive requested anonymity because they were not authorized to speak about the attack
If private patient information was accessed, hospitals will need to notify their patients.
“Our resources are singularly dedicated to regaining full operability and investigating this matter to completion,” Cooper said. “NRC Health takes our customers’ information and security very seriously, and we have and will continue to share additional updates on progress with customers on a daily basis until the issue is completely resolved.”
A recent report from Protenus found that over 41 million patient records were breached in 2019, almost triple what the healthcare industry experienced in 2018. Incidents involving business associates impacted 24 million patient records.
One incident alone, a massive security breach at third-party billing collections firm American Medical Collection Agency (AMCA), exposed the sensitive data of 21 million patients.
Akamai Technologies‘ research highlights a troubling trend: Cybercriminals are targeting application programming interfaces (APIs) at financial services firms. In the “Akamai 2020 State of the Internet Security” report, the company said up to 75% of all credential abuse attacks against the financial services industry targeted APIs directly.
In API targeting, Akamai said in an email, criminals use bots and tools that allow threading, or multiple simultaneous connections, to attempt multiple logins at once. By targeting the APIs, they hope to avoid some front-end defenses and speed up their validation times.
The research findings reveal that from May 2019 until the end of the year, there was a dramatic shift toward criminals targeting APIs.
From December 2017 through November 2019, Akamai observed 85.42 billion credential abuse attacks. Nearly 20%, or 16.55 billion, were against hostnames that were clearly identified as API endpoints. Of these, 473.5 million attacked organizations in the financial services industry.
Credential abuse attacks start when criminals take lists of usernames/passwords, called combo lists, and attempt to log into services and platforms of all kinds. The attacks are conducted via bot or all-in-one applications and are designed to mimic a person logging into a given service or platform — much as a server would view you logging into your email account or bank. The goal of these attacks is fraud and account takeover. Sometimes they are used to steal information, and they can also be used to commit financial fraud.
But not all attacks were exclusively API-focused. On August 7, 2019, Akamai recorded the single largest credential stuffing attack against a financial services firm in its records. The attack consisted of 55.1 million malicious login attempts and used a mix of API targeting and other methodologies. On August 25, in a separate incident, the criminals targeted APIs directly in a run that consisted of more than 19 million credential abuse attacks.
Steve Ragan, Akamai security researcher and principal author of the 2020 report, said in a statement that criminals are getting more creative in obtaining access to the information they need. He said criminals targeting the financial services industry pay close attention to the defenses used by these organizations and adjust their attack patterns accordingly. They’re also willing to adapt, which is why API attacks have grown by 75% over recent months, why local file inclusion (LFI) became the top web attack method, and why more than 40% of the unique distributed denial of service (DDoS) attacks observed in the report were against financial services.
Indicative of this fluid attack dynamic, the report shows that criminals continue to employ a number of methods in order to gain a stronger foothold on the server and ultimately achieve success.
SQL Injection (SQLi) accounted for more than 72% of total attacks when looking at all verticals during the 24-month period observed by the report. That rate is halved to 36% when looking at financial services attacks alone. The top attack type against the financial services sector was LFI, with 47% of observed traffic.
The report also shows that criminals continue to leverage DDoS attacks as a core component of their arsenal, particularly in targeting financial services organizations. Akamai’s observations from November 2017 to October 2019 show the financial services industry ranking third in attack volume, with gaming and high tech segments the most common targets. However, more than 40% of the unique DDoS targets were in the financial services industry, which makes this sector the top target when considering unique victims.
“Security teams need to constantly consider policies, procedures, workflows, and business needs — all while fighting off attackers that are often well organized and well-funded,” Ragan said. “Our data shows that financial services organizations are constantly improving by adopting fluid security postures, forcing criminals to change their tactics.”
Maven Clinic, a digital health startup focused women’s health services, closed a $45 million series C round on Wednesday. Icon Ventures led the funding round, bringing the New York-based startup’s fundraising total to $88 million to date.
CEO Katherine Ryder founded the company in 2014, with the idea of making women’s health services easier to access. While working for VC firm Index Ventures, she noticed many women made health decisions for their families, but few products were directed at them.
“It was just amazing to me that there was nothing there,” she said.
The company lets users conduct telehealth visits with OB/GYNs, mental health practitioners, pediatricians and other specialists. Maven also has a family benefits platform for health plans, including programs around fertility, maternity, adoption and returning to work.
In the last year, the startup has tripled its client base, striking partnerships with more than 100 companies. Ryder said Maven has gained momentum as employers look to retain working parents, and offer family benefits that include LGBTQ families and single parents.
“Employers are looking to help new moms return to work. They see a huge drop off,” Ryder said.
Maven says 90% of its members return to work, compared to the national average of 57%. The company also claims its services can reduce ER visits and lead to savings on maternity spending.
Maven Clinic has expanded its network to 1,700 providers across more than 20 specialties, the company said on Wednesday. It also recently launched a new service called Maven Wallet to help users keep track of expenses related to fertility services, egg freezing, adoption and surrogacy.
Maven plans to use the new funds to build out its existing platforms and expand into adjacent areas of care, including pediatrics, another area where new parents are seeking help.
The company will also gain a new board member in Icon Ventures General Partner Tom Mawhinney.
“Maven is addressing critical gaps in care by offering the largest digital health network of women’s and family health providers,” Mawhinney said in a news release. “With its virtual care and services, Maven is changing how global employers support working families by focusing on improving maternal outcomes, reducing medical costs, retaining more women in the workplace, and ultimately supporting every pathway to parenthood.”
Past investors Sequoia, Oak HC/FT, Spring Mountain Capital, Female Founders Fund and Harmony Partners also participated in the funding round. Maven has also drummed up a few familiar names as its investors, including actresses Reese Witherspoon, Natalie Portman, Mindy Kaling, and 23andMe CEO Anne Wojcicki.
A company developing a drug that targets a protein overexpressed on the surface of cancer cells and enables them to evade the immune system has raised more than $100 million in its latest funding round.
Burlingame, California-based ALX Oncology said Wednesday that it had raised $105 million in a Series C equity financing. Vivo Capital led the round, while Logos Capital, Janus Henderson, Foresite Capital, Cormorant Asset Management, BVF Partners and HBM Healthcare Investments are among the company’s new investors. Existing investors venBio and Lightstone Ventures also participated.
The company plans to invest the money in its lead drug candidate, ALX148, a CD47-targeting checkpoint inhibitor that it is developing in combination with other therapies in solid tumors and blood cancers. The drug is designed to maximize the clinical benefit of other monoclonal antibodies.
The drug is currently in a Phase I clinical trial of 184 participants. In the first part of the study, patients receive the drug as a single agent at escalating dose levels; in the second part, they will receive it in combination with other cancer therapies, including Merck’s PD-1 checkpoint inhibitor Keytruda (pembrolizumab) and others. It is enrolling patients with solid tumors and also with non-Hodgkin’s lymphoma, and the company is planning to further move ALX148 into Phase II clinical development.
“We see tremendous opportunity for ALX148 to help cure a wide range of cancer types and become a major new checkpoint inhibitor to combine with a variety of anti-cancer antibodies, checkpoint inhibitors and other anti-cancer agents,” Vivo Capital Managing Director Jack Nielsen said in a statement.
Another company developing a CD47-targeting drug is Menlo Park, California-based Forty Seven, whose lead candidate, magrolimab, is in Phase I and Phase II development for acute myeloid leukemia, myelodysplastic syndrome, non-Hodgkin’s lymphoma and solid tumors like colorectal, ovarian and bladder cancers. Its clinical trials also involve combination with antibody-based therapies.
The checkpoint inhibitors currently on the market – those targeting PD-1 or PD-L1 like Keytruda and Roche’s Tecentriq (atezolizumab) or CTLA-4 like Bristol-Myers Squibb’s Yervoy (ipilimumab) – work by stimulating the body’s adaptive immune system. The strategy of blocking CD47/SIRPa signaling axis works by stimulating the innate immune system’s myeloid cells. CD47 sends what is sometimes called the “don’t eat me” signal and is expressed on normal cells, but overexpressed on cancer cells. Thus, an anti-CD47 antibody works by targeting that protein and allowing myeloid cells to detect and kill cancerous cells via their corresponding receptor, SIRPa. Studies have also indicated that targeting the CD47/SIRPa axis can stimulate the adaptive immune system.