Keeps parent company Thirty Madison raises $15 million to fight male pattern baldness

Men’s hair loss brand Keeps has raised $15 million in a round co-led by Maveron and Northzone.

Thirty Madison, the healthcare startup behind the hair loss brand Keeps, has brought in a $15.25 million Series A co-led by Maveron and Northzone.

The company provides a subscription-based online marketplace for men’s hair loss prevention medications Finasteride and Minoxidil. Keeps sells these drugs direct-to-consumer, working with manufacturers to keep the costs low.

On Keeps, a subscription of Minoxidil, an over-the-counter topical treatment often referred to as Rogaine, is $10 monthly. A subscription to Finasteride, a prescription drug taken daily, is $25 per month.

It’s an end-to-end platform that is the single best place for guys who are looking to keep their hair,” Thirty Madison co-founder Steven Gutentag told TechCrunch.

Keeps is tapping into a big market. According to the American Hair Loss Association, two-thirds of American men experience some hair loss by the age of 35.

You may have heard of Hims, a venture-backed men’s healthcare company that similarly sells subscriptions to hair loss treatments, as well as oral care, skin care and treatments for erectile dysfunction. Keeps is its smaller competitor. For now, the company is focused solely on haircare, though with the new funds, Thirty Madison plans to launch Cove, a sister brand to Keeps that will provide treatments to migraine sufferers.

The company was founded last year by Gutentag and Demetri Karagas with a plan to develop several digital healthcare brands under the Thirty Madison umbrella.

“Going through this process myself of starting to experience hair loss, I was not sure where to turn,” Gutentag said. “I went online and looked up ‘why am I losing my hair,’ and if you search on Google, really for any medical condition, you usually walk away thinking you’re going to die … I was so fortunate that I got access to this high-quality specialist who could help me with my problem and I was in the position to afford those treatments but most people don’t get that access.”

Keeps also provide digital access to a network of doctors at a cost of roughly $30 per visit.

TechCrunch’s Connie Loizos wrote last year that “it’s never been a better time to be a man who privately suffers from erectile dysfunction, premature ejaculation or hair loss” because of advances and investments in telemedicine. Since then, even more money has been funneled into the space.

Hims has raised nearly $100 million to date and is rumored to be working on a line of women’s products. Roman, a cloud pharmacy for erectile dysfunction, raised an $88 million Series A last month and is launching a “quit smoking kit.” And Lemonaid Health, which also provides prescriptions to erectile dysfunction medications and more, secured $11 million last year.

Greycroft, Steadfast Venture Capital, First Round, Entrepreneurs Roundtable, HillCour and Two River also participated in Thirty Madison’s fundraise, which brings its total raised to date to $22.75 million.

Keeps parent company Thirty Madison raises $15 million to fight male pattern baldness

Men’s hair loss brand Keeps has raised $15 million in a round co-led by Maveron and Northzone.

Thirty Madison, the healthcare startup behind the hair loss brand Keeps, has brought in a $15.25 million Series A co-led by Maveron and Northzone.

The company provides a subscription-based online marketplace for men’s hair loss prevention medications Finasteride and Minoxidil. Keeps sells these drugs direct-to-consumer, working with manufacturers to keep the costs low.

On Keeps, a subscription of Minoxidil, an over-the-counter topical treatment often referred to as Rogaine, is $10 monthly. A subscription to Finasteride, a prescription drug taken daily, is $25 per month.

It’s an end-to-end platform that is the single best place for guys who are looking to keep their hair,” Thirty Madison co-founder Steven Gutentag told TechCrunch.

Keeps is tapping into a big market. According to the American Hair Loss Association, two-thirds of American men experience some hair loss by the age of 35.

You may have heard of Hims, a venture-backed men’s healthcare company that similarly sells subscriptions to hair loss treatments, as well as oral care, skin care and treatments for erectile dysfunction. Keeps is its smaller competitor. For now, the company is focused solely on haircare, though with the new funds, Thirty Madison plans to launch Cove, a sister brand to Keeps that will provide treatments to migraine sufferers.

The company was founded last year by Gutentag and Demetri Karagas with a plan to develop several digital healthcare brands under the Thirty Madison umbrella.

“Going through this process myself of starting to experience hair loss, I was not sure where to turn,” Gutentag said. “I went online and looked up ‘why am I losing my hair,’ and if you search on Google, really for any medical condition, you usually walk away thinking you’re going to die … I was so fortunate that I got access to this high-quality specialist who could help me with my problem and I was in the position to afford those treatments but most people don’t get that access.”

Keeps also provide digital access to a network of doctors at a cost of roughly $30 per visit.

TechCrunch’s Connie Loizos wrote last year that “it’s never been a better time to be a man who privately suffers from erectile dysfunction, premature ejaculation or hair loss” because of advances and investments in telemedicine. Since then, even more money has been funneled into the space.

Hims has raised nearly $100 million to date and is rumored to be working on a line of women’s products. Roman, a cloud pharmacy for erectile dysfunction, raised an $88 million Series A last month and is launching a “quit smoking kit.” And Lemonaid Health, which also provides prescriptions to erectile dysfunction medications and more, secured $11 million last year.

Greycroft, Steadfast Venture Capital, First Round, Entrepreneurs Roundtable, HillCour and Two River also participated in Thirty Madison’s fundraise, which brings its total raised to date to $22.75 million.

Nurse-1-1 lets you text a nurse for health info, learn if a doctor is needed

A new startup wants to help you figure out if your medical issue requires a visit to a doctor’s office, the ER, or can be handled over a telemedicine service, while also providing you with some basic information about the problem and its severity. Nurse-1-1, the latest company from former RunKeeper co-founder Michael Sheeley, is […]

A new startup wants to help you figure out if your medical issue requires a visit to a doctor’s office, the ER, or can be handled over a telemedicine service, while also providing you with some basic information about the problem and its severity. Nurse-1-1, the latest company from former RunKeeper co-founder Michael Sheeley, is launching today to offer a quick, affordable way to get answers from physician assistants, nurse practitioners, and registered nurses via chat.

Sheeley, a serial entrepreneur, sold his shopping app Kickscout to Mobee in 2014, and later worked on a food ordering service before starting Nurse-1-1 around two years ago.

The idea for the startup emerged from an experience he had after the birth of his daughter.

“My daughter was born with a congenital heart defect,” Sheeley explains – a health crisis that involved her having open heart surgery, he tells us. “I was sitting next to her for a week while she was recovering in the hospital….and I was Google searching everything and anything I could to learn about her condition,” he says.

But the more he read, the more confused he became, as it can be hard to parse health information found online.

He ended up connecting with his wife’s friend, a nurse practitioner, over SMS text messaging, in order to ask some of the questions that he hadn’t asked the doctors at the hospital.

“I was having these conversations with my friend, Kim, and I didn’t have to worry about it being a treatment; I didn’t have to worry about it being a prescription; and I didn’t have to worry about interrupting her busy day,” Sheeley says.

That nurse practitioner, Kim Liner, now works at Nurse-1-1 along with Meri Clare, RN; an ER doctor from Boston Children’s Hospital, Igor Shumskiy, MD; and a former marketing exec for TripAdvisor, Steve McAveeney, among others. The team is currently based out of Harvard University’s Innovation Lab.

The team opted for texting instead of calls, after doing some customer research. They found that most people preferred to communicate asynchronously – like through text messages. When offered the choice between phone calls, video chat or texting via the Nurse-1-1 website, patients choose texting at a much higher rate.

The startup also found that, often, what people first want to know when they have a health concern is what level of care they should get.

Ahead of today’s launch, the texting service was tested with over 1,200 patients and received interest from 190 nurses, who have since joined its platform. It’s free to end users if the patient’s provider is signed up on Nurse-1-1. (None have yet – but discussions are underway, Sheeley says.) Otherwise it’s $12.50 per chat.

This is much less than video visits with doctors, which typically go for around $49 or have co-pays of around $30 per visit.

 

“The triage industry is a multi-billion dollar industry. When you call your doctor late at night and get that phone call back, it’s usually a third-party service calling you. They charge $15 per call to these clinics and it’s very low quality,” Sheeley explains. “Our business model is to charge clinics only $12.50 per call…if your provider is on the platform, that money is charged to them, not to [patients.],” he notes.

When your provider is not available, the money customers pay, minus a $2.50 processing fee, will go directly to nurses instead.

In the future, Nurse-1-1 may generate referrals to telemedicine providers, allowing it to earn referral fees, too.

Already, the company found that many of its customers are moms or moms-to-be, asking questions about pregnancy, kid’s ailments, colds, flus, and the like. They’re trying to figure out if they should visit an urgent care now, or see a doctor in the morning, for example.

The service works both via the web and through an iOS app. It’s HIPAA-compliant, and data is encrypted end-to-end.

Nurse-1-1 is immediately available across the U.S. because it’s not actually prescribing or diagnosing. The company hasn’t raised outside funding, but may look to do a seed round in the near future.

Weed in space is going to be a thing now

Scientists interested in cannabis as a subject for pharmaceutical studies may find an unlikely new home for their research into the plant, its byproducts and biochemistry aboard the International Space Station. Yes, weed is going to space thanks to the work of a small Lexington, Ky.-based startup called Space Tango. The company makes a “clean […]

Scientists interested in cannabis as a subject for pharmaceutical studies may find an unlikely new home for their research into the plant, its byproducts and biochemistry aboard the International Space Station.

Yes, weed is going to space thanks to the work of a small Lexington, Ky.-based startup called Space Tango.

The company makes a “clean room” laboratory in a microwave-sized box. Because space is tight on the International Space Station, companies that want to conduct experiments in microgravity have to do more with less. And Space Tango gives them a small environment in which to perform tests and monitor the results.

Using Space Tango’s “CubeLab” modules, which slot into the larger TangoLab containers, companies like Anheuser-Busch can send barley up to the space station to observe how the crop could be cultivated in environments approaching zero gravity.

Now, Space Tango is taking its own steps to develop experiments on how the zero gravity environment could affect cannabis cultivation.

Alongside two Kentucky hemp and cannabis cultivation and retail companies, Atalo Holdings, which provides hemp genetics, and Anavii Market, an online retailer of hemp-derived cannabidiol (CBD) therapeutics, Space Tango has set up its own subsidiary to research how microgravity can be used to better cultivate particular strands of hemp for medical compounds.

“For all entrepreneurial companies in this new space area everyone is trying to hone in [sic] on what is the actual business,” said co-founder and chairman Kris Kimel of Space Tango, in an interview. “We’re trying to figure out here what’s the business now… For us, the model is looking at low earth orbit to actually develop and design applications for life on earth.”

Kimel said the company now has two micro-laboratories installed on the International Space Station and has payloads launching to the space station for corporate and university customers about six times a year.

In its early stages, the company is mainly operating on existing income. “We’re able to meet our operating expenses off of revenue,” says Kimel. “Which is great for a company that is not just three years old.”

As it looks to create these kinds of joint ventures with other companies, Kimel said that additional revenue could come from a profit-sharing agreement rather than just straight contracts for services. The new subsidiaries enhance what the company sees as its broader mission, Kimel said.

“Each time a new type of physics platform has been successfully harnessed such as electromagnetism, it has led to the exponential growth of new knowledge, benefits to humankind and capital formation,” said  Kimel, in a statement. “Using microgravity, we envision a future where many of the next breakthroughs in healthcare, plant biology and technology may well occur off the planet Earth.”

Industrialized hemp production and research and development into the crop was enabled four years ago with the passage of the 2014 U.S. Farm Bill. It was the first time in 70 years that new rules were enacted to promote research into applications for the hemp plant as fiber, food or medicine.

By taking the plants to space, Space Tango hopes to study whether the growth of certain strains can be better controlled in the absence of gravitational stresses on the plant’s development.

“When plants are ‘stressed,’ they pull from a genetic reservoir to produce compounds that allow them to adapt and survive,” said Dr. Joe Chappell, a member of the Space Tango Science Advisory Team who specializes in drug development and design. “Understanding how plants react in an environment where the traditional stress of gravity is removed can provide new insights into how adaptations come about and how researchers might take advantage of such changes for the discovery of new characteristics, traits, biomedical applications and efficacy.”

Founded by former NASA engineer Twyman Clements and Kimel, who was serving as the president of the nonprofit Kentucky Science and Technology Corp., Space Tango was spun up to be the for-profit arm that would commercialize experiments in space as a service for large businesses that wanted to take advantage of the unique properties of manufacturing in microgravity.

There have been few commercially viable products that have come from microgravity research or production, in part because it’s expensive to bring products from space to earth.

That’s why Space Tango has focused on drug discovery and pharmaceuticals and why the company is spinning up its independent subsidiary that will focus exclusively on cannabis. Pharmaceutical compounds are lightweight and can be profitable in production without enormous volumes.

“That’s why biomedicine is attractive,” Kimel said. “You’re dealing with products that are incredibly high value and incredibly low weight.”

Vital Labs’ app can measure changes in your blood pressure using an iPhone camera

Vital Labs has emerged from stealth with $1 million in funding from True Ventures.

If a twinkle in the eye of a venture capitalist could predict the longevity of a startup, Vital Labs is going all the way.

During a quick demo of the Burlingame, Calif.-based startup’s app, called Vitality, True Ventures partner Adam D’Augelli’s enthusiasm was potent. The company, which emerges from stealth today, is pioneering a new era of personalized cardiovascular healthcare, he said.

Vitality can read changes in a person’s blood pressure using an iPhone’s camera and graphics processing power. The goal is to replace blood pressure cuffs to become the most accurate method of measuring changes in blood pressure and eventually other changes in the cardiovascular system.

The app is still in beta testing and is expected to complete an official commercial rollout in 2019.

Here’s how it works: The technology relies on a technique called photoplethysmography. By turning on the light from a phone’s flash and placing a person’s index finger over the camera on the back of the phone, the light illuminates the blood vessels in the fingertip and the camera captures changes in intensity as blood flows through the vessels with each heartbeat. This technique results in a time-varying signal called the blood-pulse waveform (BPW). The app captures a 1080p video at 120 frames per second and processes that data in real-time using the iPhone’s graphics processing unit to provide a high-resolution version of a person’s BPW.

The startup was founded by Tuhin Sinha, Ph.D., the former technical director for the University of California, San Francisco’s Health eHeart Study. He’s been working on the app for several years.

“Part of the reason this project strikes a chord with me is because if I look at the stats of my own family, I probably only have 20 years left,” Sinha told TechCrunch. “Most people on my dad’s side of the family have passed away before 60 from cardiovascular disease.”

Prior to joining UCSF, Sinha was an instructor at Vanderbilt University and the director of the Center for Image Analysis, where he directed and developed medical image analysis algorithms.

He linked up with True Ventures in June 2015, raising a total of $1 million from the early-stage venture capital firm.

“[Sinha] saw an opportunity to improve a stagnant practice and invented a new approach that takes full advantage of today’s technologies,” True’s D’Augelli said in a statement.

Three years after that initial funding, Sinha says Vital Labs is looking to raise another round of capital with plans to create additional digital tools to advance cardiovascular health.

 

 

Not to be overshadowed by the Apple Watch, AliveCor announces a new 6-lead ECG reader

Apple’s announcement last week of a Watch with an FDA-approved ECG reader to track heart health looked to be the undoing of original ECG reader company AliveCor. But, to prove it still has a hearty pulse, AliveCor tells TechCrunch it is coming out with a “never-before-seen” 6-lead electrocardiogram (ECG), pending FDA approval. In a care […]

Apple’s announcement last week of a Watch with an FDA-approved ECG reader to track heart health looked to be the undoing of original ECG reader company AliveCor. But, to prove it still has a hearty pulse, AliveCor tells TechCrunch it is coming out with a “never-before-seen” 6-lead electrocardiogram (ECG), pending FDA approval.

In a care clinic, a patient typically has 12 leads, or stickers placed across their chest to pick up data from their heart. However, other ECG readers typically have one or two leads. The Apple Watch places a single lead system on the wrist. The 6-lead ECG reader is, in theory, more accurate because there are more sensors picking up more information, which could be critical in saving lives.

AliveCor’s and the Apple Watch’s current function is to pick up AFib — or the detection of an irregular heart beat. AliveCor announced earlier this month it had received FDA-approval to use its ECG readers to detect a rare but dangerous blood condition called hyperkalemia.

With 6-lead ECG readers, the AliveCor device could also pick up about 100 different diseases, according to CEO Vic Gundotra, who rattled off a bunch of long-worded maladies I can’t even begin to pronounce but he’s hoping his reader will soon be able to detect.

However, one important detection would be ST elevation — one of the key factors associated with the onset of a heart attack and which could get a person on their way to the hospital before they start displaying other physical symptoms.

Of course, Apple — which already holds 17 percent of the wearables market — could easily decide it, too, needs to add a 6-lead ECG reader to the Watch and beat AliveCor’s market yet again. But Gundotra shrugs at that suggestion.

“They could but we have some pretty good patents in the space,” he told TechCrunch, adding “Apple has done me a great service, actually. We’re a small company but you are talking to me, calling about this [because of their announcement].”

No formal name has been announced yet for the 6-lead product, but AliveCor will be working with the FDA on the regulatory pathway for it and hopes to bring it to over-the-counter consumers by 2019.

Alivecor gets a green light from FDA to screen for dangerously high potassium levels in the blood

The U.S. Food and Drug Administration has granted AliveCor the designation of ‘breakthrough device’ for it’s ability to detect a rare but dangerous blood condition called hyperkalemia without taking any blood from the patient. Hyperkalemia is a medical term describing elevated potassium levels in the blood and is usually found in those with kidney disease. […]

The U.S. Food and Drug Administration has granted AliveCor the designation of ‘breakthrough device’ for it’s ability to detect a rare but dangerous blood condition called hyperkalemia without taking any blood from the patient.

Hyperkalemia is a medical term describing elevated potassium levels in the blood and is usually found in those with kidney disease. The correct amount of potassium is critical for the function of nerve and muscles in the body, including your heart muscle. A blood potassium level higher than than 6.0 mmol/L can be dangerous and usually requires immediate treatment, according to the Mayo Clinic.

A surprising 31 million people in the U.S. suffer from chronic kidney conditions leading to potentially elevated levels of potassium. Nearly 500,000 of those with the condition are on dialysis as their kidneys are no longer able to function.

AliveCor is able to detect elevated levels of potassium in the blood using the company’s specifically trained deep neural network and data from its electrocardiograms (ECG) technology, similar to those captured by AliveCor’s KardiaMobile and KardiaBand devices.

The new designation means the FDA will begin to fast track the technology, enabling patients with kidney disease to use AliveCor for home-based detection of elevated potassium levels.

AliveCor was cleared late last year by the FDA to use its Kardiaband technology as a medical device for the Apple Watch to detect abnormal hearth rhythm. Allowing kidney and heart patients to use this technology at home would potentially save lives by detecting and warning them that something is wrong before heading into the doctor’s office to get checked.

“We are gratified that the artificial intelligence work we’re doing at AliveCor has been deemed so meaningful that it has achieved FDA ‘Breakthrough Device’ status,” AliveCor CEO Vic Gundotra said in a statement. “We view it as a key milestone in our corporate history and look forward to the further development of our non-invasive Hyperkalemia detection tools.”

Fertility startup Future Family switches to a subscription platform

Future Family, the startup offering more affordable plans for fertility services like IVF and egg freezing, is switching its model from small loans for these services to subscriptions. Fertility treatments are out of reach for most middle-income people in the U.S. The typical costs range from $12,000 to $20,000 for IVF, plus another few thousand […]

Future Family, the startup offering more affordable plans for fertility services like IVF and egg freezing, is switching its model from small loans for these services to subscriptions.

Fertility treatments are out of reach for most middle-income people in the U.S. The typical costs range from $12,000 to $20,000 for IVF, plus another few thousand for the genetic testing involved to ensure the fetus is chromosomally normal. To help, Future Family started out offering monthly payment plans for these services. However, after hearing from customers, the company has decided to switch to a subscription plan where customers can choose from several offerings and tailor a package that fits their needs.

You might be wondering what the difference is: Either you get a loan for the services you want or you sign up to pay a certain amount as a subscription for x many months for the services you want. Either way, you get the services you want with an affordable way to pay for them.

What’s new is the ability to pick the services you want, both upfront and and as you go. So, for example, if you go through egg retrieval and later realize you want to add genetic testing, you can now fold that option into your subscription plan.

“We have now moved from a financing product with concierge, to a full subscription model that offers the flexibility of other consumer subscriptions,” a spokesperson for the company told TechCrunch. “Contrast this with other financing products that have no flexibility and no customization, and do not even include services like genetic testing.”

Future Family was co-founded by former Solar City executive Claire Tomkins after she went through six rounds of IVF and spent more than $100,000 to finally get her baby, so Tomkins had some understanding of what someone might go through and how much they could rack up before seeing results.

In the past year, the company has also added male fertility testing and expanded it’s ‘Touchpoint’ fertility program to include more than 200 clinics, and it has doubled its user base in the last six months. While we don’t have firm numbers on just how many have used the company’s services, it did tell TechCrunch it has helped “tens of thousands of women, men, and couples in all 50 states.”

Subscription packages last over the course of five years and start at $150 per month for egg freezing. What you’ll get with that beginner plan is the procedure itself plus concierge care, fertility planning, clinic matching and on-boarding to the company’s digital health platform. You can see other plans for IVF on the site here.

“Subscription fertility is stress-free fertility. We want to transform people’s fertility experiences from what is currently a costly, isolating and confusing experience, to one that is affordable, easy to navigate, and supported at every step of the journey,” Tomkins said.

HP is ‘printing’ drugs for the CDC to speed up antibiotic testing

At least 2 million people in the U.S. become infected with so-called “super bugs” and at least 23,000 people die as a direct result of these infections each year, according to the Centers for Disease Control (CDC). Now, HP’s Biohacker technology is working with the CDC on a pilot program to “print” and test antibiotics […]

At least 2 million people in the U.S. become infected with so-called “super bugs” and at least 23,000 people die as a direct result of these infections each year, according to the Centers for Disease Control (CDC). Now, HP’s Biohacker technology is working with the CDC on a pilot program to “print” and test antibiotics in an effort to catch these antimicrobial resistant strains from spreading faster.

The HP D300e Digital Dispenser BioPrinter technology works by using the same set up as a regular ink printer but instead dispenses any combination of drugs in volumes from picoliters to microliters to be used for research purposes.

Part of the reason these bugs spread so rapidly often comes down to mis-use of antibiotics, leading the bacteria to develop a resistance to the drugs available. The CDC hopes to give hospital providers access to the technology nationwide to cut down on the problem.

“Once a drug is approved for use, the countdown begins until resistance emerges,” Jean Patel, PH.D. D (ABMM), Science Team Lead, Antibiotic Resistance Coordination and Strategy Unit at CDC said in a statement. “To save lives and protect people, it is vital to make technology accessible to hospital labs nationwide. We hope this pilot will help ensure our newest drugs last longer and put gold-standard lab results in healthcare providers’ hands faster.”

The 3D bioprinting sector has been experiencing rapid growth over the last few years and will continue on pace through the next decade, mainly due to R&D, according to market researchers. Innovation in the space includes printing of organs, human tissue and drug research and development.

Further, this potentially valuable antibiotic resistance research could help patient care teams stem a grim future where we experience a regression in health and life spans due to no longer having the ability to treat currently curable diseases.

The HP BioPrinter is currently used by labs and pharmaceutical companies such as Gilead, which tests for drugs used against the Ebola virus. It is also being used in various CRISPR applications. The CDC will use these printers in four regional areas spread throughout the U.S. within the Antibiotic Resistance (AR) Lab Network to develop antimicrobial susceptibility test methods for new drugs, according to HP.

The FDA OK’d an app as a form of birth control

Don’t want to get pregnant? There’s a Food and Drug Administration approved app for that. The FDA has just given the go ahead for Swedish app Natural Cycles to market itself as a form of birth control in the U.S. Natural Cycles was already in use as a way to prevent pregnancy in certain European […]

Don’t want to get pregnant? There’s a Food and Drug Administration approved app for that. The FDA has just given the go ahead for Swedish app Natural Cycles to market itself as a form of birth control in the U.S.

Natural Cycles was already in use as a way to prevent pregnancy in certain European countries. However, this is the first time a so-called ‘digital contraceptive’ has been approved in America.

The app works using an algorithm based on data given by women using the app such as daily body temperature and monthly menstrual cycles. It then calculates the exact window of days each month a woman is most fertile and therefore likely to conceive. Women can then see which days the app recommends they should avoid having sex or use protection to avoid getting pregnant.

Tracking your cycle to determine a fertile window has long been used to either become pregnant or avoid conceiving. However, Natural Cycles put a scientific spin on the age-old method by evaluating over 15,000 women to determine its algorithm had an effectiveness rate with a margin of error of 1.8 percent for “perfect use” and a 6 percent failure rate for “typical use.”

What that means is almost two in every 100 women could likely conceive on a different date than the calculated fertile window. That’s not exactly fool-proof but it is higher than many other contraceptive methods. A condom, for instance, has an 18 percent margin of error rate, according to the Centers for Disease Control (CDC).

And though the app makers were able to convince the FDA of its effectiveness, at least one hospital in Stockholm has opened an investigation with Sweden’s Medical Products Agency (MPA) after it recorded 37 unwanted pregnancies among women who said they had been using the app as their contraception method.

“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” assistant director for the health of women in the FDA’s Center for Devices and Radiological Health Terri Cornelison said in a statement.

However, she also acknowledged there was a margin of error in the app’s algorithm and other contraceptive methods. “Women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device,” she said.