Health
FDA approves first at-home sterile insemination kit to help with infertility: 'Gives me goosebumps'
It’s now possible for women to get pregnant via insemination in the comfort of their own homes.
The FDA recently approved the first-ever, at-home sterile insemination kit.
PherDal Fertility Science received clearance last month after various tests did not raise “any new questions on the safety or effectiveness” of the product, as stated in the FDA’s approval letter.
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PherDal’s creator and CEO, Dr. Jennifer Hintzsche of Dixon, Illinois, confirmed to Fox News Digital that there have been 34 babies born from the first 200 proof-of-concept kits that were released.
“Even saying that still gives me goosebumps,” Hintzsche said in an interview.
Dr. Jennifer Hintszche is pictured with her husband, Ryan Westphal, and their two children, Lois and Zackary, in a 2019 portrait. (Brittany Moore )
The at-home kit is intended for users who are struggling to conceive or have chosen not to conceive naturally.
The kit includes three sterile, circular cups and three syringes, all packaged separately, for an independent-use option.
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While other brands offer at-home insemination kits, PherDal is the only multi-patented, sterile, FDA-cleared at-home insemination device on the market, according to the company.
“Sterility matters because studies show that disruptions (dysbiosis) in the reproductive microbiome are linked directly to infertility,” said Hintzsche.
The Hintszches are pictured with their daughter, Lois, on the left. Right, the PherDal syringe and circular sterile cup enable full access to samples. “If you’re paying $3,000 for a few milliliters of a sample, every drop counts,” Hintzsche said. (Don Umland Photography/PherDal)
PherDal’s first batch of kits sold out in just 90 days, which is when Hintszche realized she might be “on to something.”
“It really is a simple device, but there’s so much science behind its effectiveness,” she said.
Driven by desire for family
Hintzsche said she assumed that after she married her husband in Oct. 2016, she would get pregnant, have multiple babies and live happily ever after “behind a white picket fence.”
But after 14 months of unsuccessful conception efforts, she sought out a fertility specialist who ran some tests.
That’s when Hintzsche discovered that she had “unexplained infertility,” as the doctor said that “everything looks normal” and “we don’t know what’s wrong.”
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The doctor then handed Hintzsche an application for a $10,000 loan to begin IVF treatment.
As a biologist with a PhD, Hintzsche started digging into infertility research in search of an alternative to “invasive” treatments.
After marrying her husband in Oct. 2016, Hintzsche tried unsuccessfully for 14 months to get pregnant before seeking out a fertility specialist. (PherDal)
“Instead of going into the uterus, if you put [sperm] right at the opening of the cervix, and it was done [in a] sterile [manner] in the clinic, it had the same live birth rate [as IVF],” she said. “And I was like, ‘Why has no one ever offered me this?’”
The scientist ordered lab supplies and gave her prototype a try.
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Hintzsche got pregnant in Dec. 2017, after only two attempts with the kit.
Her daughter, Lois, was born on Sept. 11, 2018.
Motivated by that success, Hintzsche launched a new career with the goal of helping other people who were facing the same struggles.
Dr. Jennifer Hintszche of Illinois and her family are pictured cheering on the Chicago Bears in 2023. (Dr. Jennifer Hintzsche)
“I think everyone deserves something they can try first, and it shouldn’t take $10,000 just to [have the chance] to become a mother.”
Through feedback from PherDal customers, Hintzsche has fine-tuned her product to accommodate a variety of scenarios.
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Many women report feeling “shame” when they face infertility, Hintzsche said — which is something PherDal aims to eliminate.
From other PherDal moms, Hintzsche has also heard that at-home insemination “takes the pressure off” couples who have gone to great lengths to conceive without success.
Many PherDal dads have reported that they’d rather not return to a clinic to provide a sample, since “that’s not the way they envisioned growing a family,” Hintszche said.
Another family, shown here, used PherDal to conceive their child. (Camber Lynn Ostwinkle, Wink Photographs)
“It gives people this private, safe option that doesn’t [involve] any drugs,” Hintzsche said. “It’s not going to work for everyone … but for a lot of people, maybe the sperm just needs a little boost.”
It’s important for people to confirm with their doctor that it is healthy for them to become pregnant before attempting a method like PherDal, she added.
Infertility specialist sees promise, warns of potential pitfalls
Dr. Remm Sabouni, a reproductive endocrinologist and infertility specialist at Aspire Houston Fertility Institute, shared with Fox News Digital her appreciation for reproductive products that allow “more choice while maintaining safety.” (She was not involved in PherDal’s development.)
The expert noted that PherDal is potentially useful for members of the LGBTQIA+ community who would like to try at-home insemination.
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It is also useful for patients who have undergone infertility evaluation and are seeking more natural options, she said, or for male partners who have erectile issues or who want to avoid intercourse as a means of producing sperm.
Sabouni did point out one “major caveat” of a product like PherDal, which is the challenge of understanding who qualifies as a good candidate for its use.
Dr. Hintzsche, pictured with her husband, named the product PherDal because she used her PhD to “prove” she was fertile, she said. (Dr. Jennifer Hintzsche)
The fertility expert cautioned about “some pitfalls,” including lack of fertility assessment and limited efficacy for certain medical conditions such as male factor infertility, tubal blockages or ovulatory disorders in women.
Sabouni also mentioned a lack of randomized controlled trials “demonstrating the viability of this treatment” — as well as the lack of medical supervision and the risk of misuse.
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“While I recognize the potential benefits of such devices for at-home use, particularly for individuals and couples trying to conceive, I would strongly caution that they not be seen as a replacement for consulting with a fertility specialist,” she said.
“If conception is not achieved after using these methods for a recommended period (typically a year for those under 35, and six months for women over 35 or with irregular periods), it is advisable to seek professional medical advice,” the doctor added.
“I think everyone deserves something they can try first, and it shouldn’t take $10,000 just to [have the chance] to become a mother,” said the company’s founder (not pictured). (iStock)
Customers do not need a prescription to purchase.
FDA clearance advises that consumers should only purchase the product for up to six months before seeking other options.
“It really is just an affordable and accessible way that people can try if they’re struggling,” Hintzsche said.
Fox News Digital reached out to the FDA requesting comment.
The company said that pre-orders for PherDal kits, which are 100% made in the USA, are currently available at pherdal.com for $199.
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In a dramatic turn of events that’s captured the attention of animal lovers worldwide, Punch — the young macaque at a zoo in Japan famous for his inseparable bond with a stuffed orangutan toy — has reached a major milestone in his journey toward social integration.
On Thursday, visitors and staff at the Ichikawa Zoological and Botanical Garden witnessed a breakthrough: Punch was seen cuddling with and hitching a ride on the back of a fellow macaque.
Punch’s story began with hardship. He was abandoned by his mother shortly after his birth in July 2025 — and to ensure his survival, zookeepers stepped in to hand-rear the primate.
On Jan. 19, 2026, the zoo officially began the process of reintegrating Punch into the “monkey mountain” enclosure.
The transition was initially fraught with tension.
Punch’s story began with hardship when he was abandoned by his mother shortly after he was born. To help him, zookeepers gave him a stuffed toy that he began dragging around everywhere he went. (David Mareuil/Anadolu via Getty Images)
As a hand-reared infant, Punch was bullied and ignored by the established group of monkeys.
He was often seen huddled alone with his orange plush companion while the rest of the troop interacted.
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In an official statement released Feb. 27, the Ichikawa Zoological and Botanical Garden detailed the meticulous care behind this process.
Previous viral videos showed Punch bullied by the rest of the troop, running to his plushy toy for comfort. (David Mareuil/Anadolu via Getty Images)
“From an animal welfare perspective, our primary goal is to reintegrate Punch with the troop,” the zoo said.
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The strategy involved nursing Punch within the enclosure, so the troop could recognize him as one of their own, and pairing him with a gentle young female macaque prior to his full release to build his confidence.
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The latest footage, captured by X user @tate_gf, suggested the zoo’s patience is paying off.
The video shows Punch seeking physical contact not from his toy, but from another monkey — eventually climbing onto its back for a vital social behavior for young macaques: the “piggyback ride.”
The zoo’s strategy appears to be paying off: Punch, shown at far left, was recently seen riding on the back of a fellow macaque. (David Mareuil/Anadolu via Getty Images)
While Punch still carries his stuffed toy for comfort during moments of perceived danger, the zoo remains optimistic about his progress.
The organization cited the successful 2009 case of Otome, another hand-reared macaque who eventually outgrew her stuffed toy, successfully integrated — and went on to raise four offspring of her own.
The zoo has had crowds coming to see Punch, with hundreds of people lining up to get inside to see the young star, according to reports.
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“I’m hoping Punch has a good life like everybody else does, and think he’s a cute little guy,” one person commented online.
“Such a precious baby,” another person wrote.
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This story discusses suicide. If you or someone you know is having thoughts of suicide, please contact the Suicide & Crisis Lifeline at 988 or 1-800-273-TALK (8255).
Artificial intelligence has been touted as a boon to healthcare, but a new study has revealed its potential shortcomings when it comes to giving medical advice.
In January, OpenAI launched ChatGPT Health, the medical-focused version of the popular chatbot tool.
The company introduced the tool as “a dedicated experience that securely brings your health information and ChatGPT’s intelligence together, to help you feel more informed, prepared and confident navigating your health.”
But researchers at the Icahn School of Medicine at Mount Sinai have found that the tool failed to recommend emergency care for a “significant number” of serious medical cases.
The study, published in the journal Nature Medicine on Feb. 23, aimed to explore how ChatGPT Health — which is reported to have about 40 million users daily — handles situations where people are asking whether to seek emergency care.
Artificial intelligence has been touted as a boon to healthcare, but a new study has revealed its potential shortcomings when it comes to giving medical advice. (iStock)
“Right now, no independent body evaluates these products before they reach the public,” lead author Ashwin Ramaswamy, M.D., instructor of urology at the Icahn School of Medicine at Mount Sinai in New York City, told Fox News Digital.
“We wouldn’t accept that for a medication or a medical device, and we shouldn’t accept it for a product that tens of millions of people are using to make health decisions.”
Emergency scenarios
The team created 60 clinical scenarios across 21 medical specialties, ranging from minor conditions to true medical emergencies.
Three independent physicians then assigned an appropriate level of urgency for each case, based on published clinical practice guidelines in 56 medical societies.
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The researchers conducted 960 interactions with ChatGPT Health to see how the tool responded, taking into account gender, race, barriers to care and “social dynamics.”
While “clear-cut emergencies” — such as stroke or severe allergy — were generally handled well, the researchers found that the tool “under-triaged” many urgent medical issues.
The team created 60 clinical scenarios across 21 medical specialties, ranging from minor conditions to true medical emergencies. (iStock)
For example, in one asthma scenario, the system acknowledged that the patient was showing early signs of respiratory failure — but still recommended waiting instead of seeking emergency care.
“ChatGPT Health performs well in medium-severity cases, but fails at both ends of the spectrum — the cases where getting it right matters most,” Ramaswamy told Fox News Digital. “It under-triaged over half of genuine emergencies and over-triaged roughly two-thirds of mild cases that clinical guidelines say should be managed at home.”
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Under-triage can be life-threatening, the doctor noted, while over-triage can overwhelm emergency departments and delay care for those in real need.
Researchers also identified inconsistencies in suicide risk alerts. In some cases, it directed users to the 988 Suicide and Crisis Lifeline in lower-risk scenarios, and in others, it failed to offer that recommendation even when a person discussed suicidal ideations.
“ChatGPT Health performs well in medium-severity cases, but fails at both ends of the spectrum.”
“The suicide guardrail failure was the most alarming,” study co-author Girish N. Nadkarni, M.D., chief AI officer of the Mount Sinai Health System, told Fox News Digital.
ChatGPT Health is designed to show a crisis intervention banner when someone describes thoughts of self-harm, the researcher noted.
OpenAI launched ChatGPT Health, the medical-focused version of the popular chatbot tool, in January 2026. (Gabby Jones/Bloomberg via Getty Images)
“We tested it with a 27-year-old patient who said he’d been thinking about taking a lot of pills,” Nadkarni said. “When he described his symptoms alone, the banner appeared 100% of the time. Then we added normal lab results — same patient, same words, same severity — and the banner vanished.”
“A safety feature that works perfectly in one context and completely fails in a nearly identical context … is a fundamental safety problem.”
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The researchers were also surprised by the social influence aspect.
“When a family member in the scenario said ‘it’s nothing serious’ — which happens all the time in real life — the system became nearly 12 times more likely to downplay the patient’s symptoms,” Nadkarni said. “Everyone has a spouse or parent who tells them they’re overreacting. The AI shouldn’t be agreeing with them during a potential emergency.”
Fox News Digital reached out to Open AI, creator of ChatGPT, requesting comment.
Physicians react
Dr. Marc Siegel, Fox News senior medical analyst, called the new study “important.”
“It underlines the principle that while large language models can triage clear-cut emergencies, they have much more trouble with nuanced situations,” Siegel, who was not involved in the study, told Fox News Digital.
ChatGPT and other LLMs can be helpful tools, a doctor said, but they “should not be used to give medical direction.” (iStock)
“This is where doctors and clinical judgment come in — knowing the nuances of a patient’s history and how they report symptoms and their approach to health.”
ChatGPT and other LLMs can be helpful tools, Siegel said, but they “should not be used to give medical direction.”
“Machine learning and continued input of data can help, but will never compensate for the essential problem – human judgment is needed to decide whether something is a true emergency or not.”
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Dr. Harvey Castro, an emergency physician and AI expert in Texas, echoed the importance of the study, calling it “exactly the kind of independent safety evaluation we need.”
“Innovation moves fast. Oversight has to move just as fast,” Castro, who also did not work on the study, told Fox News Digital. “In healthcare, the most dangerous mistakes happen at the extremes, when something looks mild but is actually catastrophic. That’s where clinical judgment matters most, and where AI must be stress-tested.”
Study limitations
The researchers acknowledged some potential limitations in the study design.
“We used physician-written clinical scenarios rather than real patient conversations, and we tested at a single point in time — these systems update frequently, so performance may change,” Ramaswamy told Fox News Digital.
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Additionally, most of the missed emergencies happened in situations where the danger depended on how the condition was changing over time. It’s not clear whether the same problem would happen with acute medical emergencies.
Because the system had to choose just one fixed urgency category, the test may not reflect the more nuanced advice it might give in a back-and-forth conversation, the researchers noted.
ChatGPT Health is designed to show a crisis intervention banner when someone describes thoughts of self-harm. (iStock)
Also, the study wasn’t large enough to confidently detect small differences in how recommendations might vary by race or gender.
“We need continuous auditing, not one-time studies,” Castro noted. “These systems update frequently, so evaluation must be ongoing.”
‘Don’t wait’
The researchers emphasized the importance of seeking immediate care for serious issues.
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“If something feels seriously wrong — chest pain, difficulty breathing, a severe allergic reaction, thoughts of self-harm — go to the emergency department or call 988,” Ramaswamy advised. “Don’t wait for an AI to tell you it’s OK.”
The researchers noted that they support the use of AI to improve healthcare access, and that they didn’t conduct the study to “tear down the technology.”
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“These tools can be genuinely useful for the right things — understanding a diagnosis you’ve already received, looking up what your medications do and their side effects, or getting answers to questions that didn’t get fully addressed in a short doctor’s visit,” Ramaswamy said.
“That’s a very different use case from deciding whether you need emergency care. Treat them as a complement to your doctor, not a replacement.”
“This study doesn’t mean we abandon AI in healthcare.”
Castro agreed that the benefits of AI health tools should be weighed against the risks.
“AI health tools can increase access, reduce unnecessary visits and empower patients with information,” he said. “They are not inherently unsafe, but they are not yet substitutes for clinical judgment.”
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“This study doesn’t mean we abandon AI in healthcare,” he went on. “It means we mature it. Independent testing and stronger guardrails will determine whether AI becomes a safety net or a liability.”
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