FDA grants emergency authorization to system that decontaminates N95 respirator masks for re-use

The global coronavirus pandemic has meant that there’s a widespread effort to develop and advance creative solutions to new problems, like worldwide shortages of necessary front-line medical equipment. One piece of gear that’s necessary for protecting the health of medical workers treating COVID-19 patients are N95 respirator masks, which are masks that specifically filter out very fine particles, including shed virus, with high efficacy. These are in extremely short supply, but a new FDA emergency use authorization could help significantly lessen that burden by opening a path to re-use of N95 masks originally intended for one-time use.

Research, development and lab management company Battelle has received special emergency authorization from the U.S. healthcare regulator to put into use a system it developed to decontaminate used N95 respirator masks using concentrated hydrogen peroxide. The system is able to turn single use respirators into masks that can be used up to 20 times, with a 2.5-hour decontamination process between each use.

The Battelle system is already in operation at its Ohio facility, with a decontamination capacity of up to 80,000 masks per day. That’s a considerable dent in a supply need that will be faced by essentially every healthcare facility faced with a high concentration of COVID-19 patients. The company is working with Columbus -based OhioHealth as its first healthcare system partner, but says that it’ll also start decontaminating masks for three other new major healthcare systems in the area beginning this week.

In order to ensure that everything is done as safely and transparently as possible, the N95 masks that Battelle collects for decontamination and re-use will all go back to the same healthcare facility from which they were collected, and they’ll be labeled with a serial number that provides tracking, which will also include the number of times they’re re-used.

Battelle actually worked with the FDA in 2015 to develop and demonstrate this technology – specifically in anticipation of a scenario where a global pandemic caused a shortage of available equipment. They’re also not the only ones using this technology: Duke University is also using vaporized hydrogen peroxide to decontaminate used respirators, and it’s making the protocols that it established widely available, with compatibility with a number of existing decontamination systems already in use in healthcare facilities.

This technology and method actually aren’t new, and are frequently used in decontamination of equipment used in labs that deal with biohazardous material. Its use specifically for turning single-use N95 masks into reusable gear is new, however – but this EUA from the FDA could pave the way for broader authorized, safe use of the technology to help with the growing need for more equipment.

Saudi spies tracked phones using flaws the FCC failed to fix for years

Lawmakers and security experts have long warned of security flaws in the underbelly of the world’s cell networks. Now a whistleblower says the Saudi government is exploiting those flaws to track its citizens across the U.S. as part of a “systematic” surveillance campaign.

It’s the latest tactic by the Saudi kingdom to spy on its citizens overseas. The kingdom has faced accusations of using powerful mobile spyware to hack into the phones of dissidents and activists to monitor their activities, including those close to Jamal Khashoggi, the Washington Post columnist who was murdered by agents of the Saudi regime. The kingdom also allegedly planted spies at Twitter to surveil critics of the regime.

The Guardian obtained a cache of data amounting to millions of locations on Saudi citizens over a four-month period beginning in November. The report says the location tracking requests were made by Saudi’s three largest cell carriers — believed to be at the behest of the Saudi government — by exploiting weaknesses in SS7.

SS7, or Signaling System 7, is a set of protocols — akin to a private network used by carriers around the world — to route and direct calls and messages between networks. It’s the reason why a T-Mobile customer can call an AT&T phone, or text a friend on Verizon — even when they’re in another country. But experts say that weaknesses in the system have allowed attackers with access to the carriers — almost always governments or the carriers themselves — to listen in to calls and read text messages. SS7 also allows carriers to track the location of devices to just a few hundred feet in densely populated cities by making a “provide subscriber information” (PSI) request. These PSI requests are typically to ensure that the cell user is being billed correctly, such as if they are roaming on a carrier in another country. Requests made in bulk and excess can indicate location tracking surveillance.

But despite years of warnings and numerous reports of attacks exploiting the system, the largest U.S. carriers have done little to ensure that foreign spies cannot abuse their networks for surveillance.

One Democratic lawmaker puts the blame squarely in the Federal Communication Commission’s court for failing to compel cell carriers to act.

“I’ve been raising the alarm about security flaws in U.S. phone networks for years, but FCC chairman Ajit Pai has made it clear he doesn’t want to regulate the carriers or force them to secure their networks from foreign government hackers,” said Sen. Ron Wyden, a member of the Senate Intelligence Committee, in a statement on Sunday. “Because of his inaction, if this report is true, an authoritarian government may be reaching into American wireless networks to track people inside our country,” he said.

A spokesperson for the FCC, the agency responsible for regulating the cell networks, did not respond to a request for comment.

A long history of feet-dragging

Wyden is not the only lawmaker to express concern. In 2016, Rep. Ted Lieu, then a freshman congressman, gave a security researcher permission to hack his phone by exploiting weaknesses in SS7 for an episode of CBS’ 60 Minutes.

Lieu accused the FCC of being “guilty of remaining silent on wireless network security issues.”

The same vulnerabilities were used a year later in 2017 to drain the bank accounts of unsuspecting victims by intercepting and stealing the two-factor authentication codes necessary to log in sent by text message. The breach was one of the reasons why the U.S. government’s standards and technology units, NIST, recommended moving away from using text messages to send two-factor codes.

Months later the FCC issued a public notice, prompted by a raft of media attention, “encouraging” but not mandating that carriers make efforts to bolster their individual SS7 systems. The notice asked carriers to monitor their networks and install firewalls to prevent malicious requests abuse.

It wasn’t enough. Wyden’s office reported in 2018 that one of the major cell carriers — which was not named — reported an SS7 breach involving customer data. Verizon and T-Mobile said in letters to Wyden’s office that they were implementing firewalls that would filter malicious SS7 requests. AT&T said in its letter that it was in the process of updating its firewalls, but also warned that “unstable and unfriendly nations” with access to a cell carrier’s SS7 systems could abuse the system. Only Sprint said at the time that it was not the source of the SS7 breach, according to a spokesperson’s email to TechCrunch.

T-Mobile did not respond to a request for comment. Verizon (which owns TechCrunch) also did not comment. AT&T said at the time it “continually works with industry associations and government agencies” to address SS7 issues.

Fixing SS7

Fixing the problems with SS7 is not an overnight job. But without a regulator pushing for change, the carriers aren’t inclined to budge.

Experts say those same firewalls put in place by the cell carriers can filter potentially malicious traffic and prevent some abuse. But an FCC working group tasked with understanding the risks posed by SS7 flaws in 2016 acknowledged that the vast majority of SS7 traffic is legitimate. “Carriers need to be measured as they implement solutions in order to avoid collateral network impacts,” the report says.

In other words, it’s not a feasible solution if it blocks real carrier requests.

Cell carriers have been less than forthcoming with their plans to fix their SS7 implementations. Only AT&T provided comment, telling The Guardian that it had “security controls to block location-tracking messages from roaming partners.” To what extent remains unclear, or if those measures will even help. Few experts have expressed faith in newer systems like Diameter, a similar routing protocol for 4G and 5G, given there have already been a raft of vulnerabilities found in the newer system.

End-to-end encrypted apps, like Signal and WhatsApp, have made it harder for spies to snoop on calls and messages. But it’s not a panacea. As long as SS7 remains a fixture underpinning the very core of every cell network, tracking location data will remain fair game.

Divesting from one facial recognition startup, Microsoft ends outside investments in the tech

Microsoft is pulling out of an investment in an Israeli facial recognition technology developer as part of a broader policy shift to halt any minority investments in facial recognition startups, the company announced late last week.

The decision to withdraw its investment from AnyVision, an Israeli company developing facial recognition software, came as a result of an investigation into reports that AnyVision’s technology was being used by the Israeli government to surveil residents in the West Bank.

The investigation, conducted by former U.S. Attorney General Eric Holder and his team at Covington & Burling, confirmed that AnyVision’s technology was used to monitor border crossings between the West Bank and Israel, but did not “power a mass surveillance program in the West Bank.”

Microsoft’s venture capital arm, M12 Ventures, backed AnyVision as part of the company’s $74 million financing round which closed in June 2019. Investors who continue to back the company include DFJ Growth and OG Technology Partners, LightSpeed Venture Partners, Robert Bosch GmbH, Qualcomm Ventures, and Eldridge Industries.

Microsoft first staked out its position on how the company would approach facial recognition technologies in 2018, when President Brad Smith issued a statement calling on government to come up with clear regulations around facial recognition in the U.S.

Smith’s calls for more regulation and oversight became more strident by the end of the year, when Microsoft issued a statement on its approach to facial recognition.

Smith wrote:

We and other tech companies need to start creating safeguards to address facial recognition technology. We believe this technology can serve our customers in important and broad ways, and increasingly we’re not just encouraged, but inspired by many of the facial recognition applications our customers are deploying. But more than with many other technologies, this technology needs to be developed and used carefully. After substantial discussion and review, we have decided to adopt six principles to manage these issues at Microsoft. We are sharing these principles now, with a commitment and plans to implement them by the end of the first quarter in 2019.

The principles that Microsoft laid out included privileging: fairness, transparency, accountability, non-discrimination, notice and consent, and lawful surveillance.

Critics took the company to task for its investment in AnyVision, saying that the decision to back a company working with the Israeli government on wide-scale surveillance ran counter to the principles it had set out for itself.

Now, after determining that controlling how facial recognition technologies are deployed by its minority investments is too difficult, the company is suspending its outside investments in the technology.

“For Microsoft, the audit process reinforced the challenges of being a minority investor in a company that sells sensitive technology, since such investments do not generally allow for the level of oversight or control that Microsoft exercises over the use of its own technology,” the company wrote in a statement on its M12 Ventures website. “Microsoft’s focus has shifted to commercial relationships that afford Microsoft greater oversight and control over the use of sensitive technologies.”

 

 

Detroit Auto Show canceled in preparation for FEMA to turn venue into field hospital

The North American International Auto Show, which was scheduled for June in Detroit, has been canceled as the COVID-19 pandemic continues to spread and the city prepares to repurpose the TCF Center into a temporary field hospital.

NAIAS is held each year in the TCF Center, formerly known as the Cobo Center. Organizers said they expected the Federal Emergency Management Agency to designate the TCF Center as a field hospital.

“Although we are disappointed, there is nothing more important to us than the health, safety and well-being of the citizens of Detroit and Michigan, and we will do what we can to support our community’s fight against the coronavirus outbreak,” NAIAS Executive Director Rod Alberts said in an emailed statement.

The NAIAS is the latest in a long line of events and conventions that have been canceled as COVID-19, the disease caused by the coronavirus, has spread from China to Europe, and now the U.S. and the rest of the world.

More than 100 convention centers and facilities around the country are being considered to potentially serve as temporary hospitals. Alberts said it became clear that TCF Center would be an inevitable option to serve as a care facility.

The NAIAS, also known as the Detroit Auto Show, will be held in June 2021. Organizers are discussing plans for a fundraising activity later this year to benefit the children’s charities that were designated as beneficiaries of the 2020 Charity Preview event.

This year’s show was highly anticipated because it had moved from January to summer, following years of encouragement to schedule it during the warmer months.

All tickets purchased for the 2020 NAIAS show, including tickets for the Public Show, Industry Preview and Charity Preview will be fully refunded, organizers said. Charity Preview ticket holders will be given the option of a refund, or the opportunity to donate the proceeds of their refund to one of the nine designated Charity Preview beneficiaries. The NAIAS ticket office will be in contact with all ticket holders, according to the organizers.

A new FDA-authorized COVID-19 test doesn’t need a lab and can produce results in just 5 minutes

There’s a new COVID-19 test from healthcare technology maker Abbott that looks to be the fastest yet in terms of producing results, and that can do so on the spot right at point-of-care, without requiring a round trip to a lab. This test for the novel coronavirus causing the current global pandemic has received emergency clearance for use by the U.S. Food and Drug Administration, and will begin production next week, with output of 50,000 per day possible starting next week.

The new Abbott ID NOW COVID-19 test uses the Abbott ID NOW diagnostics platform, which is essentially a lab-in-a-box that is roughly the size of a small kitchen appliance. It’s size, and the fact that it can produce either a positive result in just five minutes, or a negative one in under 15, mean that it could be a very useful means to extend coronavirus testing beyond its current availability to more places including clinics and doctor’s offices, and cut down on wait times both in terms of getting tested and receiving a diagnosis.

Unlike the rapid tests that have been used in other countries, and that received a new type of authorization under an FDA guideline that doesn’t confirm the accuracy fo the results, this rapid testing solution uses the molecular testing method, which works with saliva and mucus samples swabbed from a patient. This means that it works by identifying a portion of the virus’ DNA in a patient, which means it’s much better at detecting the actual presence of the virus during infection, whereas other tests that search the blood for antibodies that are used in point-of-care settings can only detect antibodies, which might be present in recovered patients who don’t actively have the virus.

The good news for availability of this test is that ID NOW, the hardware from Abbott that it runs on, already “holds the largest molecular point-of-care footprint in the U.S.,” and is “widely available” across doctor’s offices, urgent care clinics, emergency rooms and other medical facilities.

In total, Abbott now says that it believes it will produce 5 million tests in April, split between these new rapid tests and the lab tests that it received emergency use authorization for by the FDA on March 18.

Testing has been one of the early problems faced by the U.S. in terms of getting a handle on the coronavirus pandemic: The country has lagged behind other nations globally in terms of per capita tests conducted, which experts say has hampered its ability to properly track and trace the spread of the virus and its resulting respiratory disease. Patients have reported having to go to extreme lengths to receive a test, and endure long waits for results, even in cases where exposure was likely and their symptoms match the COVID-19 profile.

The FDA just okayed multiple 15-minute blood tests to screen for coronavirus, but there are caveats

On Thursday, the FDA amended their emergency policy around diagnostic testing for SARS-CoV-2, the novel coronavirus that causes COVID-19. Following on a change made March 16, the agency opened the door for a number of specific private entities and labs to develop and distribute tests that can provide results on the spot in as little as 15 minutes – but there are some pretty big caveats to keep in mind as you hear about more of these coming to market.

The tests, which are ‘serological,’ meaning they identify the presence of antibodies in a person’s blood, differ considerably from the molecular testing that is currently in use under Emergency Use Authorization (EUA) by FDA-approved labs and drive-through testing sites. The serological tests show that a person has developed antibodies to SARS-CoV-2, which means they very likely came into contact with it (and either have it, or have already recovered from having it). The molecular tests actually detect the presence of viral DNA in the blood stream, which is a much more definitive indicator that they currently have an active infection (at least at the time the swab was taken).

Serological tests have still been used widely in countries where the response to the COVID-19 pandemic has been shown to be effective, including in China, Taiwan and Singapore. They’ve also been used in different communities in the U.S., based on earlier guidelines around private lab diagnostics, but on March 26 the FDA named 29 entities who had provided notification to the agency as required and are now therefore able to distribute their tests.

It’s important to note that these tests have not been reviewed or validated by the FDA, unlike those molecular tests that are included in the organizations emergency use category. Instead, the FDA “does not intend to object to the development and distribution by commercial manufacturers” of these tests, provided they meet a number of criteria, including qualifying the results of their reported test results with the following information:

  • This test has not been reviewed by the FDA.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

The FDA specifically notes in its emergency use FAQ that these entities have reported their own validation of these tests, and that they won’t be pursuing Emergency Use Authorization. That said, there’s now nothing stopping the entities on this list from distributing their tests, which means they will be able to be put to use in testing Americans and painting a larger picture of the potential spread of the novel coronavirus – with the caveat noted above that the FDA doesn’t consider these tests used alone to be positive confirmation of a definite SARS-CoV-2 case, or conversely, a sure indicator that someone doesn’t have the virus.

Still, in the absence of better options like expanded available of the tests that are approved under the EUA, these serological tests (many of which can provide on-site results with just a pinprick of blood) will be useful in painting a more accurate picture of the overall spread and reach of the coronavirus, especially for smaller clinics, GP clinics and local labs that don’t have priority access to the equipment and supplies needed for the molecular testing efforts.

For instance, ne test on this list, the Healgen Scientific COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device, requires no instrumentation and can provide results in just 15 minutes. Distributor Ideal Rehab Care is working with its legal representation Fox Rothschild to begin importing the tests from Singapore for use “as soon as possible.”

The FDA updating its website with Healgen as one of the entities that have notified it of intent to use its serological test is what unlocked the ability for the company to begin distribution: It’s still illegal for anyone not on this list to do so, and the FDA still also specifically prohibits the use of at-home serological tests on its official guidelines.

OneWeb to file for bankruptcy as effort to securing funding, including from investor Softbank, falls through

Broadband constellation satellite operator OneWeb has officially filed for bankruptcy protection in the U.S., after attempts to secure new funding, including from existing investor SoftBank, fell through, TechCrunch has learned. The Financial Times also reported on the failure of its funding attempt on Friday, based on its own separate sources. The company will be laying off most of its staff, with a team remaining in place to continue to operate its existing satellites in space, according to our sources.

OneWeb, founded in 2012 as WorldVu Satellites, had been seeking to build out a constellation of broadband internet satellites that would operate in low Earth orbit, providing low-cost connections to customers on the ground with coverage that extends into more remote and hard-to reach areas that are not addressed by current ground-based networks.

Earlier this month, Bloomberg reported that OneWeb had been considering a bankruptcy protection filing, while also weighing other options. One of those other options was a new funding round targeting a raise of around $2 billion. The company had previously raised $3 billion over multiple rounds, including a $1.3 billion and $1.2 billion round in 2019 and 2016 respectively, both of which had SoftBank as lead investor.

OneWeb also just completed a launch earlier in March, bringing the total number of its satellites in orbit to 74. The company then reduced its headcount by as much as 10% through layoffs we reported last week.

This latest step essentially means that OneWeb had exercised all other options for continued cash to stay afloat, and it required considerable reserves in order to continue its planned rapid pace of launches, with the ultimate aim of putting over 650 satellites in orbit in order to provide its service globally. SoftBank backing away as an investor leaves a big hole that’s difficult to fill in terms of scale and depth of pockets among the rest of the VC field, and the company has been stepping away from a number of its more high-profile investments since encountering difficulties of its own in terms of returning value on the biggest checks its cut, including for WeWork .

OneWeb’s funding situation can’t have been helped by the current global comic climate, also, rocked as it has been by the ongoing coronavirus pandemic. Reports suggest that at least some investors are taking a more conservative approach, suggesting that traditional routes to securing more investment may have proven more difficult to unlock than usual.

Tesla to reduce on-site staff at Nevada gigafactory by 75%

Tesla is reducing number of on-site workers at its Nevada gigafactory by 75% in response to the growing spread of COVID-19, according to an update from Storey County, where the massive plant is located.

The information, which was first reported by Bloomberg, was part of a larger update on the Tahoe Reno Industrial Center and its response to COVID-19, a disease caused by coronavirus. The privately owned privately owned 107,000-acre industrial park, known as TRIC, is home to the Tesla gigafactory, Google and Switch as well as a Walmart distribution center and Petsmart.

Tesla could not be reached for comment.

Companies in TRIC are taking COVID-19 serious and are regularly report measures being taken to adhere to the established guidelines while maintaining essential operations, Storey County Manager Austin Osborne said in the letter posted on the county’ website. Those measures include checking employee temperatures, creating central access, allowing remote work and creating distance between work stations.

Tesla’s decision to reduce staff follows a move by its gigafactory partner Panasonic to pull all 3,500 of its employees from the site over concerns about the spread of COVID-19. Panasonic said March 20 that it would ramp down operations this week and then close for 14 days. That move only affected Panasonic employees. Tesla also employs thousands of workers at the so-called Gigafactory 1 in Sparks, Nevada.

Gigafactory 1, which broke ground in June 2014, is a critical ingredient in Tesla’s goal to accelerate the world’s transition to sustainable energy by expanding global battery capacity and reducing the cost of electric vehicles. And Panasonic has been its most important partner as a supplier and partner in that project.

The factory produces Model 3 electric motors and battery packs, in addition to Tesla’s energy storage products, Powerwall and Powerpack. Panasonic makes the cells, which Tesla then uses to make battery packs for its electric vehicles.

Tesla has several two factories in the U.S., including in Fremont, Calif., where it produces the Model X, Model S, Model 3 and now the Model Y. Tesla has reduced staff at the Fremont plant from more than 10,000 workers to about 2,500.

Earlier this week, the company sent out an email informing workers that two Tesla employees had tested positive for COVID-19. The internal email, which was viewed by TechCrunch, didn’t indicate where these employees worked.

Tesla employs more than 48,000 people at locations throughout the U.S. These two employees had been working at home for nearly two weeks, according to the email. The employees were not symptomatic in the office, and both are quarantined at home and recovering well, according to the email from Tesla’s EHS department head Laurie Shelby.

Clearstep’s COVID-19 chat-based screener goes in-depth to preserve healthcare resources

There are a growing number of symptom checker and screening tools that you can use at home if you suspect you might have contracted the new coronavirus that is causing the global COVID-19 pandemic. Most of these are relatively simple, including around three or four questions that basically cover the top reported symptoms experienced by anyone who has confirmed to have had the disease. Chatbot-based symptom checking software startup Clearstep has created its own COVID-19 screener, which goes more in-depth to combine symptom checking with screening for potential exposure to the virus.

The reason Clearstep’s tool is designed to go a step further than most is simple, according to co-founder and COO Bilal Naved – the symptoms reportedly suffered by those affected by COVID-19 include many that could indicate other serious conditions, including an impending heart attack. More effective and comprehensive screening can also help reduce the burden on an already heavily-taxed healthcare system, which seems likely to only get busier over time as the number of cases across the U.S. continues to climb.

Naved and cofounder Adeel Malik, both of whom have worked in health at Johns Hopkins University and been involved in a number of academic scientific publications, developed Clearstep as a front-line way to connect patients with the right care, using remote screening facilitated via chatbot on their desktop or mobile device. Clearstep’s aim fits naturally with one of the key needs in the ongoing coronavirus pandemic – effective screening that can provide individuals with clear and accurate guidance about what steps they need to take to seek care, and when.

“Our country is entering a time of a lot of uncertainty, but but also a time where there could be a true, critical threat to the integrity of the healthcare system,” Naved said in an interview. “If the rate of infection of this really reaches some projections, we might not have enough hospital beds or ICU beds to deal with all of this […] So it’s all about urgency and speed here and rapid response, but also being able to deliver the highest quality product. We are built off of nurse protocols, and we’re the only ones that have access to this in a publicly available chatbot format that has been used in over 200 million encounters in over 95% of the call centers around the country.”

Clearstep’s screener asks a range of questions about symptoms, travel, potential contact with anyone either diagnosed with COVID-19 or likely to have it based on their own travel and other factors. Once you go through the questions, which are presented in a fairly standard and easy-to-follow chat message format, the tool provides you an evaluation of what next steps you should take. It’ll provide you advice about whether or not you need testing for COVID-19 based on current CDC guidelines about who should be tested – and alert you about whether you should seek care for any other reason, independent of your potential coronavirus exposure.

The Clearstep team is also making sure to stay on top of new research as it emerges regarding the presentation and likelihood of symptoms in COVID-19 patients. Their approach focuses on data-driven representation of the symptoms that most people are likely to have, and then also taking the less likely presenting symptoms and building a model wherein those compound and add up to a total. The team is “keeping a pulse in the literature” published in peer-reviewed sources and adapting its screener as it needs to, as well, Naved says.

Ultimately, Naved thinks that where Clearstep can contribute is in its ability to integrate quickly with healthcare providers, providing a triage tool that can give frontline responders a way to interface with the public safely, while also helping to ensure that all the health issues that are not related to COVID-19 but that are still serious and require care don’t get left behind.

“We were able to go from first conversation to contract signed to configured and implemented in total of nine days,” Naved says about their speed of response. “The contracts took six days and in three days, we we customized, put in behind their branding, integrate itd and deployed it out to an entire population in Florida for a health system there […] The symptom checkers that are being put out there need to be able to integrate with those places that are seeing the massive influx of volume and may not be able to handle it, because that’s our responsibility right now.”

TuSimple partners with supplier ZF to mass produce self-driving truck tech

Self-driving truck startup TuSimple is partnering with automotive supplier ZF to develop and produce autonomous vehicle technology such as sensors on a commercial scale.

The partnership, slated to begin in April, will cover China, Europe and North America. The two companies will co-develop sensors needed in autonomous vehicle technology such as cameras, lidar, radar and a central compute. As part of the partnership, ZF will contribute engineering support to validate and integrate TuSimple’s autonomous system into the vehicle.

TuSimple launched in 2015 and has operations in China, San Diego and Tucson, Ariz. The company has been working on a “full-stack solution,” an industry term that means developing and bringing together all of the technological pieces required for autonomous driving. TuSimple is developing a Level 4 system, a designation by the SAE that means the vehicle takes over all of the driving in certain conditions.

TuSimple has managed to scale up its operations and attract investors even as other companies in the nascent autonomous vehicle technology industry have faltered. The company has raised nearly $300 million to date from investors such as Sina, UPS and Tier 1 supplier Mando Corporation. It’s now making about 20 autonomous trips between Arizona and Texas each week with a fleet of more than 40 autonomous trucks. All of the trucks have a human safety operator behind the wheel.

The partnership is an important milestone for TuSimple as the startup prepares to bring autonomous-ready trucks to market, TuSimple chief product officer Chuck Price said in a statement. The plan is for TuSimple to combine its self-driving software with ZF’s ability to build automotive grade products.

The partnership doesn’t remove every barrier for TuSimple. Moving from development to deployment takes millions of dollars of investment. If a company can move from testing to commercial deployment, it must still navigate daily operations efficiently in the aim of becoming profitable.