FDA orders Juul to stop selling its vaping products in the US

The axe has fallen for e-cigarette maker Juul.

The FDA ordered the company to stop selling and distributing its ubiquitous vaping devices in the U.S. Thursday, a dramatic end for a company that dominated the e-cigarette market and was valued at $38 billion at the top of its game.

Juul will no longer be able to sell its vapes nor its 5% or 3% tobacco and menthol-flavored pods in the U.S. without “risk[ing] enforcement action” from the U.S. Food and Drug Administration. Retailers will also be prohibited from stocking Juul products in the U.S.

The FDA’s ban against Juul come after the company failed to provide consistent evidence about the safety of its vapes and tobacco pods.

“As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards,” Acting Director of the FDA’s Center for Tobacco Products Michele Mital said. “However, the company did not provide that evidence and instead left us with significant questions.”

In a statement to TechCrunch, Juul’s Chief Regulatory Officer Joe Murillo said that the company would pursue a stay and is exploring its other options to counter the FDA’s ban on its products. The company pushed back against the FDA’s characterization of the information it provided to the regulatory agency.

“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being ‘appropriate for the protection of the public health,’” Murillo said.

The FDA clarifies that its actions don’t directly restrict individual possession or use of Juul products, though obtaining the company’s vapes and pods is about to be much more difficult for U.S.-based users.

Regulatory woes had already cut deeply into the company’s valuation, but the FDA’s actions spell outright doom for its U.S. operations. Juul competitors Reynolds American and NJOY Holdings previously received authorization and will be allowed to continue selling their own products, though the FDA maintains that tobacco is harmful and addictive even when vaped.

Smartphone re-commerce platform Cashify bags $90 million in new funding

Cashify, a marketplace for gadgets trade-ins and buybacks in India, has raised $90 million in a new financing round as it looks to expand its business in the world’s second-largest smartphone market.

Prosus Ventures and NewQuest Capital Partners led the seven-year-old Indian startup’s Series E funding, Cashify said on Thursday. Paramark Ventures and existing backers including Bessemer Venture Partners, Blume Ventures and Olympus Capital also participated in the new round, which included some secondary transactions. The new round, which multiples the startup’s valuation by 2.5 times since Series C funding, takes Cashify’s to-date funding to over $130 million.

Cashify operates an eponymous platform — both online and physical stores and kiosks — for users to sell and buy used smartphones, tablets, laptops and other gadgets. Users sell to and buy devices from the startup by visiting the startup’s website or app.

Additionally, Cashify also works with all top smartphone makers including Apple, Samsung, Xiaomi and Samsung to power their refurbishing programs. The startup repairs and refurbishes those devices, giving them new lives without which they may have likely ended up in the garbage bin, explained Mandeep Manocha, founder and chief executive of Cashify, in an interview with TechCrunch.

“We have covered the full spectrum, offering a full-stack solution,” he said. Smartphones business accounts for roughly 90% of the startup’s revenue, said Manocha.

The startup is tapping into India’s large market, where over 100 million smartphones ship each year and tens of millions of used smartphones get resold.

A significant number of smartphones sold in the country — and beyond — get returned to the e-commerce or retail outlets. Many of these firms work with Cashify as well, said Manocha.

But selling old smartphones requires establishing a high trust factor with consumers. Cashify has been expanding its presence in India through physical retail points in recent years to solidify this trust, Manocha said.

“We have invested heavily in enhanced refurbished capability, and at the same time, selling smartphones to end consumers. We are taking an omnichannel approach, where we have established over 120 stores of our own in 65 cities in the country. We are hoping to increase our presence to 200 cities this year,” he said.

Cashify also has operations outside of India, including in markets including the UAE, Turkey and Bangladesh. In the international regions, the firm licenses its enterprise business. The firm’s enterprise business includes offerings such as a diagnostic tool to evaluate a smartphone’s functional and physical aspects.

“For instance, if you’re an e-commerce firm that wants to start a smartphone exchange program, you can use our diagnostic tool to pick up old phones from customers’ doorsteps. In Turkey, additionally, we have empowered microentrepreneurs to build a buyback business in their market,” he said.

Cashify will also deploy the fresh funds to expand its team. The startup said it has been very cautious about hiring new talent in the past, a factor that has allowed it to not cut workforce even in the uncertain times.

“While there is a large opportunity set in the re-commerce space, Cashify has a clear edge as a category leader with its focus on customer experience and its data and tech-first approach to drive scale and working capital minimization,” said Amit Gupta, partner and head of India and Southeast Asia, NewQuest Capital Partners, in a statement.

“Its leadership position and success of the PhonePro brand are a testament to the quality of the management team and their vision for the sector. We’re excited to be a part of their journey and a part of the consumer revolution that they’re driving.”

Smartphone re-commerce platform Cashify bags $90 million in new funding

Cashify, a marketplace for gadgets trade-ins and buybacks in India, has raised $90 million in a new financing round as it looks to expand its business in the world’s second-largest smartphone market.

Prosus Ventures and NewQuest Capital Partners led the seven-year-old Indian startup’s Series E funding, Cashify said on Thursday. Paramark Ventures and existing backers including Bessemer Venture Partners, Blume Ventures and Olympus Capital also participated in the new round, which included some secondary transactions. The new round, which multiples the startup’s valuation by 2.5 times since Series C funding, takes Cashify’s to-date funding to over $130 million.

Cashify operates an eponymous platform — both online and physical stores and kiosks — for users to sell and buy used smartphones, tablets, laptops and other gadgets. Users sell to and buy devices from the startup by visiting the startup’s website or app.

Additionally, Cashify also works with all top smartphone makers including Apple, Samsung, Xiaomi and Samsung to power their refurbishing programs. The startup repairs and refurbishes those devices, giving them new lives without which they may have likely ended up in the garbage bin, explained Mandeep Manocha, founder and chief executive of Cashify, in an interview with TechCrunch.

“We have covered the full spectrum, offering a full-stack solution,” he said. Smartphones business accounts for roughly 90% of the startup’s revenue, said Manocha.

The startup is tapping into India’s large market, where over 100 million smartphones ship each year and tens of millions of used smartphones get resold.

A significant number of smartphones sold in the country — and beyond — get returned to the e-commerce or retail outlets. Many of these firms work with Cashify as well, said Manocha.

But selling old smartphones requires establishing a high trust factor with consumers. Cashify has been expanding its presence in India through physical retail points in recent years to solidify this trust, Manocha said.

“We have invested heavily in enhanced refurbished capability, and at the same time, selling smartphones to end consumers. We are taking an omnichannel approach, where we have established over 120 stores of our own in 65 cities in the country. We are hoping to increase our presence to 200 cities this year,” he said.

Cashify also has operations outside of India, including in markets including the UAE, Turkey and Bangladesh. In the international regions, the firm licenses its enterprise business. The firm’s enterprise business includes offerings such as a diagnostic tool to evaluate a smartphone’s functional and physical aspects.

“For instance, if you’re an e-commerce firm that wants to start a smartphone exchange program, you can use our diagnostic tool to pick up old phones from customers’ doorsteps. In Turkey, additionally, we have empowered microentrepreneurs to build a buyback business in their market,” he said.

Cashify will also deploy the fresh funds to expand its team. The startup said it has been very cautious about hiring new talent in the past, a factor that has allowed it to not cut workforce even in the uncertain times.

“While there is a large opportunity set in the re-commerce space, Cashify has a clear edge as a category leader with its focus on customer experience and its data and tech-first approach to drive scale and working capital minimization,” said Amit Gupta, partner and head of India and Southeast Asia, NewQuest Capital Partners, in a statement.

“Its leadership position and success of the PhonePro brand are a testament to the quality of the management team and their vision for the sector. We’re excited to be a part of their journey and a part of the consumer revolution that they’re driving.”

Airspace Link’s drone tracking platform gathers government customers before going global

Detroit-based Airspace Link has positioned itself as a provider of increasingly important infrastructure in the burgeoning drone services space, letting operators get local and federal approval quickly. With $23 million in new backing, the company now plans to take its platform to other countries looking to get their drone industries off the ground.

The company’s main offering is an online service that helps anyone working with UAVs to get FAA permission to fly by showing the necessary safety protocols are in place. This process, like any form of red tape, is especially difficult for startups and individuals to manage, and even large companies with compliance teams would like it to be easier.

“The drone industry for beyond line of sight, things like food delivery, have been held back by this,” said CEO Michael Healander. “We all know drones can do these things, but integration in the national infrastructure isn’t there. Operators are building their own systems to prove they have radar and surveillance systems, to calculate the probability of crashing on people, on critical infrastructure … you have to build a safety case to the FAA.”

Airspace Link partially automates this process, tracking ground-based infrastructure like radar coverage, notable other flights and assets in the area, and so on.

“Our goal is to tell the operator, ‘there’s a crop duster coming into your area, so stand down, and here’s a place to land,’” Healander said. But unlike other companies marketing their services as software for drone pilots, Airspace Link is positioning itself as an infrastructure provider at the state and local level.

“Municipalities are white-labelling the Airspace Link platform and saying, ‘That’s Michigan’s system.’ You’re not proving your safety case to the FAA there — the state is providing that service,” he explained. For a fee, of course, but it’s a convenience fee, not charging for use of the airspace — if you want to do your own paperwork, you can. CFO Bill Johnson thinks local governments are looking for a way to turn this from a line item into a revenue generator.

“Similar to how roads are used — we’re enabling economic activity in that region, we’re enabling partners and technological advancement. Everybody stands to benefit from this advance in the ecosystem,” he said.

This will likely only increase as FAA regulations continue to clamp down on drone operations, in particular a mandate beginning in September (with fines starting a year later) that all drones broadcast their location. That’s something that promises a lot of incoming for service providers in the sector, and it’s part of why the company is raising money.

Airspace Link CEO Michael Healander and CFO Bill Johnson. Image Credits: Airspace Link

“The reason we’re stepping on the gas is, over the next four years it’s a little bit of a land grab. And we’re trying to do it before people figure out how we’re doing it,” Healander said. Which is to say, building themselves into the government pipeline as infrastructure rather than selling to individuals and companies.

“We’re going to pour the gasoline on a few areas for expansion here in the U.S., but global expansion is the main reason we pulled the capital up. Multiple countries want things like this and drone companies are going global too,” he continued.

As an example he suggested the UAE, where after years of lax drone regulations the country suddenly forbade all drone operations a few months ago pending new policies. Emulating the FAA (which has overseen the most drone research and commerce) and companies like Airspace Link is the easiest and quickest path forward for these nations, which like any state or city want to explore the possibilities of UAV services.

Airspace Link is partnering with Thales, a global airspace monitoring company, and ESRI, the location data giant, to make sure they can roll out a product in places like Dubai, which despite the demand they represent, are not simple to adapt and localize a product to.

The $23.1 million B round was led by Avanta Ventures, the VC arm of CSAA Insurance Group — representing another category with an interest in easing red tape and quantifying risk. Ultimately something like Airspace Link could be a contributor or requirement for insurance policies. The round also included investments from Morningside, Caprock, Altos Ventures, Indicator Ventures, 2048 Ventures, Detroit Venture Partners and Thales Group.

The company is hiring fast, nearing 50 employees now, and expects to grow even faster as it pursues the next phase of its ambitions. “If we’re going to go global, we’re gonna have to build a global team,” said Healander.

Brain data startup Rune Labs gets FDA clearance for Apple Watch-based Parkinson’s tracker

Rune Labs, a precision neurology company in San Francisco, announced that its StrivePD software ecosystem for Parkinson’s disease has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) to begin using the Apple Watch to collect and measure data from Parkinson’s patients.

The FDA approval is another reason the Apple Watch is a big player in helping people with Parkinson’s. While there are several medical-grade devices capable of tracking Parkinson’s symptoms, many consumers will want an Apple Watch because it is familiar to them and has other uses — like fitness tracking, heart rate monitoring and, most recently, medication tracking, among other things.

The StrivePD software uses Apple’s Movement Disorder API (Application Programming Interface) to track tremors and dyskinetic symptoms of Parkinson’s from the Apple Watch. The motion data is collected in an iPhone app, allowing patients to take notes about their symptoms, overall mood, medication usage and more.

Image Credits: Rune Labs

Other companies, such as Cerebellia, are also making use of Apple’s Movement Disorder API to give Parkinson’s patients similar information. However, the FDA clearance means that the StrivePD app is the first significant use of Apple’s software tools for measuring movement disorders since Apple released the features in 2018.

Aura Oslapas, a Parkinson’s patient and the developer of the original StrivePD app, said in a statement, “When people with Parkinson’s are prescribed new medications, adjusting how much to take and when to take it until they find something that works can be a lengthy process. StrivePD helps people track their symptoms and improvements, accelerating the time to an optimal medication schedule — and with today’s clearance, more people will have access to this life-changing technology.”

“StrivePD on Apple Watch is the long-awaited union of quantitative and qualitative data that encourages better care and communication between patients and clinicians while also empowering people with Parkinson’s who are striving to live better every day,” Oslapas said.

Rune Labs’ goal is to use combined data — from the Apple Watch, Rune Labs’ StrivePD software, and information from other sources, like a Medtronic implant to measure brain signals — to inform a doctor’s decisions on how to treat a patient.

This is also a significant milestone for the startup as it seeks to expand its work with pharma and Medtech companies. Without the advanced technology, doctors can only gather data about a Parkinson’s patient’s movements by observing them during a short clinical visit. It’s also difficult for a patient suffering from a neurological disorder to monitor every involuntary movement at home without a device helping them.

“As we have seen in oncology, the introduction of large quantities of real-world data has the power to transform drug development and fundamentally change disease prognosis. This clearance is a major step towards building a similar paradigm in neurology,” Brian Pepin, CEO of Rune Labs, added. “With all of the data we will collect and the patients we will reach through this clearance, we will make sure the right participants enroll in trials and help our pharma and Medtech partners run more efficient trials with higher quality outcomes data, thereby enabling more therapies to come to market quickly to help those suffering from Parkinson’s.”

Rune Labs told TechCrunch that the software had been used by patients at the University of California at San Francisco for a year and Mount Sinai for six months. The FDA approval means clinicians now have ways to bill patients when reviewing data and lets trial sponsors use the findings for studies, the company said.

Apple has internally explored how to use the Apple Watch and iPhone to monitor Parkinson’s symptoms as well as filed for a patent application for more advanced technology to treat or diagnose the disease. In 2021, Apple researchers published data demonstrating that the watch could accurately track changes in the motor symptoms of Parkinson’s patients.

While the Cupertino tech giant is not formally involved with the Rune Labs project, Rune Labs spokesperson Elizabeth Eaton told The Verge that Apple updated its software to match FDA requirements and wrote a letter of support as part of Rune Labs’ FDA application. However, Eaton told TechCrunch that Rune “cannot comment on the Apple Watch software requirements, and cannot comment further on Apple’s involvement.”