MacRumors

The Food and Drug Administration today announced that it has selected nine companies to join its voluntary Pre-Cert pilot program, which is designed to foster innovation through the creation of a less restrictive regulatory framework that will lead to faster acceptance of health-related software and, in some cases, products.

Companies accepted to the program include Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily.

With its program, the FDA is aiming to create a more tailored approach toward digital health technology by looking at the software developer rather than the product to establish a firm-based pre-certification program for these digital health tools. The companies accepted to the program will be reviewed for software design, validation, and maintenance and to determine if they meet the FDA's quality standards for pre-certification.

Companies who have been pre-certified may be able to submit less information to the FDA before marketing a new digital health tool, speeding up the approval of new services and technologies. The FDA is also considering allowing pre-certified companies to avoid submitting products for premarket review in some situations.

As part of the program, Apple will provide the FDA with access to the measures it use to develop, test, and maintain software products. Apple has agreed to allow visits from FDA staff and offer information about its quality management system.

"Our method for regulating digital health products must recognize the unique and iterative characteristics of these products," said Dr. Gottlieb. "We need to modernize our regulatory framework so that it matches the kind of innovation we're being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product."

For Apple, this program could be a major boon as it has several digital health-related tools like Health, CareKit, and ResearchKit, and FDA approval is likely one of the major roadblocks to releasing new health-related products that are rumored to be in the works, such as some kind of device for monitoring blood glucose.

Apple CEO Tim Cook has said that Apple does not want to put the Apple Watch through the FDA approval process, but should the program go well, Apple may also have fewer regulations to contend with when it comes to the future of the Apple Watch, which could allow for new, more advanced health-monitoring capabilities.

Apple today released the first official update to its new iOS 11 operating system, iOS 11.0.1. iOS 11.0.1 comes just a week after Apple released iOS 11 to the public.

The iOS 11.0.1 update can be downloaded to all eligible devices over-the-air in the Settings app. To access the update, go to Settings --> General --> Software Update.

Today's update addresses several minor bugs that have been discovered following the release of the iOS 11 golden master. According to Apple's release notes the update includes bug fixes for iPhone and iPad.

iOS 11 is a major update to the iOS operating system with a redesigned Lock screen experience, a new customizable Control Center, a new Siri voice, a redesigned App Store, and an overhauled interface for the iPad. For more info on all the new features in iOS 11, check out our iOS 11 roundup.

Update: As noted by Ars Technica, iOS 11.0.1 appears to fix an Exchange e-mail server bug that prevented many users from sending email from Outlook, Office 365, and Exchange Server email accounts. In a support document covering the feature, Apple now says customers can fix the issue by updating to iOS 11.0.1.

When the iPhone X launches on November 3, initial supply of the smartphone available to purchase could be limited to around 12 million units, according to Jeff Pu, an analyst at Taipei-based Yuanta Investment Consulting.

Pu told Nikkei Asian Review that Foxconn likely manufactured around 2 million iPhone X devices in September. He said the number should increase to 10 million in October, and reach a total of 40 million by the end of the year, down from his original forecast of 45 million units earlier this year.

If accurate, that means there would be just over 12 million iPhone X handsets available to purchase when the device launches in under six weeks.

The report corroborates that the TrueDepth camera and facial recognition system is a major bottleneck for iPhone X production, as KGI Securities analyst Ming-Chi Kuo said in a research note earlier this week.

Two executives working for iPhone suppliers told Nikkei Asian Review that 3-D sensor part makers are still struggling to reach a satisfactory level of output, and to boost their yield rate. This rate measures the number of usable or saleable units from a batch of components or final products produced. A low yield rate is likely to hurt a company's margins and bottom line.

Reports about limited availability surrounding an iPhone launch surface every year, but rumors suggest the iPhone X might be even harder to get your hands on than a 256GB iPhone 7 Plus in Jet Black last year.

Apple released the iPhone 8 and iPhone 8 Plus on Friday, September 22, and device teardowns were underway within hours, courtesy of iFixit and TechInsights. The firms received different models for teardown, with iFixit's model featuring a Qualcomm baseband while TechInsights' featured an Intel modem, continuing Apple's trend of opting for Intel modems in phones which do not require CDMA network support.

The baseband parts in each iPhone were revealed to be new chips from their respective vendors, with the CDMA phone featuring Qualcomm's new X16 gigabit-class modem and the Intel-based model featuring the similarly new XMM 7480 modem. Each model also included an update to the transceiver module to go along with the modem, but the functional changes in the RF signal chain mostly stopped there.

In addition to higher peak speeds compared to their predecessors, both of these modems offer other potential benefits. Comparing the network compatibility pages of the iPhone 7 against the iPhone 8 shows that the bands supported are largely unchanged, and this is reflected in the small changes to the power amplifier modules (PAMs) found within the RF chain.

Besides gigabit-level peak theoretical speeds, the X16 modem brings several other advances, including up to 4x carrier aggregation for a total bandwidth of up to 80 MHz compared to the 60 MHz found in the MDM9645M (X12) powering the iPhone 7. Qualcomm's X16 modem also supports T-Mobile US's new 600 MHz LTE spectrum, Band 71. Apple does not list support for Band 71 on the model sold for use on T-Mobile, which means that either Intel's modem does not support it for the appropriate T-Mobile model or Apple elected not to include support for it in the phone's antenna/PAM structure.

The Intel XMM 7480, by contrast, only has a maximum theoretical peak of 600 Mbps, and while it also supports up to 4x carrier aggregation, two of these channels are limited to 10 MHz, capping overall bandwidth at 60 MHz. Intel has boosted its band support to a total of more than 33, claiming an industry leading number, but there are likely other deficiencies compared to the Qualcomm modem which have been accepted due to Apple's desire to have supplier diversity for this component.

Regardless, it is clear that both of these modems are improvements over their predecessors, yet Apple dedicated no time to talking about advanced cellular capabilities for any of its phones in the media event earlier this month. Instead, the main reason for upgrading to these new modems likely lies in power consumption.

The teardowns have revealed that Apple has reduced the size of the batteries in the iPhone 8 lineup while maintaining battery life claims across the board. The squeeze on the iPhone X will be even worse, given Apple's claims of iPhone 8 Plus-like battery life in a non-Plus type form factor. While there are several other advancements likely behind the scenes there, it seems clear Apple wanted to get more efficient in its cellular radio chains.

This will also be an area to watch in the iPhone X, as the cellular RF chain is one of the biggest consumers of space in the phone. According to its spec page, the iPhone X will support the same bands across two models as its 8-branded brethren, so space may have to come from elsewhere.

The advancements in baseband modem power efficiency likely come from two different sources for Qualcomm and Intel. The X16 is built on a 14nm FinFET process according to Qualcomm, which likely has several advantages over the 28nm RF process utilized in its previous modems.

Intel, on the other hand, claims up to 15 percent lower power usage compared to its previous-generation modem, which could be thanks in part to the newly included envelope tracker for voltage control, which reduces power usage and heat. While it is not clear which process Intel's modem is built on, it seems likely it is still a 28nm process from TSMC, as Intel still works on the technology lineage from its Infineon acquisition. Nevertheless, future iPhones will be well-positioned to include higher bandwidth and more diverse network capabilities in the future, even if the modems they use stay the same.

Nearly two years after Amazon stopped selling the Apple TV, a listing for the Apple TV 4K has been spotted on the website by 9to5Mac.

The Apple TV 4K is currently listed as out of stock, but the fact that it has been added back is fueling speculation that Amazon may be prepared to launch its Prime Video app on the tvOS App Store imminently.

At its Worldwide Developers Conference in June, Apple confirmed that Amazon Prime Video is coming to Apple TV later this year. At its iPhone X event earlier this month, it reiterated that release date.

An unverified rumor earlier this week claimed Amazon Prime Video may launch on the Apple TV alongside the debut of the NFL's Thursday Night Football games on the online retailer's streaming video service this week.

Amazon Video allows Prime members to instantly stream tens of thousands of movies and TV episodes, with hundreds of thousands of titles available to buy or rent, including many that are 4K and HDR.

Amazon removed all Apple TV and Chromecast product listings from its website in October 2015 because the devices did not offer Prime Video, which it said may cause confusion for customers.

Of course, the Apple TV and Chromecast also compete with Amazon's own Fire TV streaming media players.

Apple said Amazon had never submitted a Prime Video app for the tvOS App Store, or else it would have been happy to offer it. The app has been available for iPhone and iPad and several other platforms for many years.

Whatever the case may be, it appears Prime Video for Apple TV might finally be just around the corner.

Since hitting an all-time high of $164.94 on September 1, Apple's stock price has steadily declined throughout the month. Apple's closing price of $150.55 on Monday represents a nearly nine percent decline in just under four weeks.

Despite some negativity surrounding the stock, one Wall Street analyst believes the recent skid is a buying opportunity.

"We believe concerns around the strength of this cycle are misplaced and we would be aggressive buyers of the stock during this correction," said Brian White, a longtime Apple analyst at investment banking firm Drexel Hamilton.

White believes the staggered launch of the iPhone 8 and iPhone X is confusing industry observers, who are perhaps worried by reports of shorter lines at Apple retail stores and lower adoption rates of the iPhone 8 and iPhone 8 Plus.

"We believe more consumers in the developed parts of the world will pass on the iPhone 8/8 Plus and buy the iPhone X," added White, in a research note obtained by MacRumors. "Those that are on the fence will likely wait to see the iPhone X."

White is one of the most bullish Apple analysts, with a lofty $208 price target for the iPhone maker. If the price were to rise that high, Apple would be over a trillion dollar company based on market capitalization.

Raymond James analyst Tavis McCourt also said Apple's recent pullback is a "trading opportunity." His survey indicated there could be higher demand for the iPhone X than the firm initially anticipated.

Apple's slide has held back the Dow Jones, which is still up around 1.5 percent since the start of September. But it's not the only tech stock in the red, as Amazon, Facebook, and Netflix all declined Monday.

By comparison, Apple's stock price was up nearly 5 percent over this same period in each of the past two years.

Apple is up over 1 percent in early market trading today.

iFixit has shared an Apple TV 4K teardown, providing a closer look at the device's internal design and components.

We already know the Apple TV 4K is equipped with Apple's 64-bit A10X Fusion chip, and now the teardown confirms the device has a total of 3GB of LPDDR4 RAM supplied by SK Hynix. That's up from 2GB RAM in the previous Apple TV.

The new power supply is rated for 12V at 1.083A, a modest increase over the 12V at 0.917A power supply in the previous Apple TV.

According to the teardown, Apple merged the new fan with the heat sink/EMI shield assembly from the fourth-generation Apple TV to create a larger thermal assembly for cooling and ventilation.

iFixit said the bottom of the unit has been redesigned with a total of eight exhaust ports and a new, replaceable fan driven by a Nidec brushless motor.

Beyond the return of a Gigabit Ethernet port and the removal of the USB-C diagnostic port, which we learned about before the teardown, the Apple TV 4K's design is largely the same as the previous Apple TV.

iFixit gave the Apple TV 4K a repairability score of 8 out of a possible 10 points. The device is easy to open and has modular components, but they're soldered to the logic board, so board-level soldering or full board replacements are required.

Previously unconfirmed details about the internal specifications of Apple's iPhone X appear to have been revealed on China's official communications certification board, including the device's system memory, CPU clock speed, and battery capacity.

First spotted this morning by mobile leaker Steve Hemmerstoffer, the filing with the Chinese Ministry of Industry and Information Technology's Telecommunication Equipment Certification Center (TENAA) lists the iPhone X as having a 2,716mAh battery. For reference, the iPhone 8 is believed to have a 1,821mAh capacity battery.

The step up in battery capacity is probably a direct result of the iPhone X's OLED screen, a display technology that despite usually requiring less energy than an equivalent LCD panel, probably draws more overall power because of its 5.8-inch size (iPhone 8 and iPhone 8 Plus have 4.7-inch and 5.5-inch screens, respectively).

The TENAA listing also gives the A11 Bionic chip a 2.4GHz clock speed and says the handset is backed by 3GB of RAM, two details that are believed to conform with the iPhone 8 Plus.

iPhone X pre-orders officially begin on October 27 and in-store availability is expected on November 3, although rumors suggest the device will be in short supply until early 2018.

The iPhone 8 and iPhone 8 Plus are more expensive for Apple to manufacture than the iPhone 7 and iPhone 7 Plus, according to component cost estimates research firm IHS Markit shared today with Bloomberg.

An entry-level iPhone 8 with 64GB of storage costs Apple an estimated $247.51 in raw materials, an increase of almost $10 compared to the $237.94 it cost Apple to make last year's 32GB iPhone 7.

The 64GB iPhone 8 Plus costs an estimated $288.08, up from $270.88 for the iPhone 7 Plus.

To compensate for the increased cost, Apple charges $699 for the 64GB iPhone 8 in the United States, up from the $649 starting price it charged for the 32GB iPhone 7 in 2016. The iPhone 8 Plus is priced starting at $799, up from $769 in 2016.

"The added value went to memory, camera, and processing. That's where we can materially identify where they've improved the overall product, and hence why they can command a higher price for it," according to Wayne Lam, an analyst at IHS.

According to Bloomberg, some of the most expensive components in the iPhone 8 and 8 Plus include the screens and the mechanical enclosures. Apple's new glass-bodied devices are built around a strong internal frame and include new displays with True Tone support.

Compared to iPhone 7 pricing, the wireless charging module increases costs by $2, the A11 Bionic chip costs $5 more, and the larger 256GB storage options increase prices by $6.

IHS's component costs are only estimates of what the iPhone 8 and the iPhone 8 Plus cost to manufacture, and sometimes those estimates are not spot on. For example, while IHS told Bloomberg cost $237.94 to manufacture an iPhone 7 in 2016, its initial estimates following the iPhone 7's release were at $219.80.

These estimates also only look at raw component costs and do not take into account other iPhone manufacturing expenses like research and development, software creation, advertising, and distribution, so this information, while interesting, is not an accurate measurement of Apple's profit margin for the iPhone 8 and the iPhone 8 Plus.

Back in 2015, Apple CEO Tim Cook said that cost breakdowns are generally "much different than the reality." "I've never seen one that is anywhere close to being accurate," he added.

The initial version of macOS High Sierra released this morning limits the new Apple File System (APFS) to Macs that have all-flash built-in storage, excluding iMacs and Mac mini machines that feature Fusion Drives.

Apple announced the limitation last week in a support document that said the initial release would not allow Fusion Drives to be converted to APFS, implying future support, and now Apple software engineering chief Craig Federighi has confirmed APFS will indeed be coming to Fusion Drives in a later update.

Federighi shared the info in an email sent to MacRumors reader Michiel, who asked if APFS would be added later.

"Yes, we plan to add support in a future update," replied Federighi.

Fusion Drives, available as a storage option for Apple's iMac and Mac mini desktop machines, combine a hard drive with flash storage to provide the speed of an SSD with the affordability of a standard hard drive. Frequently accessed files are stored using flash storage, while less frequently used files are moved to the hard drive.

The first macOS High Sierra beta released in June did include support for Fusion Drives and converted iMacs and Mac minis to APFS, but support was removed in subsequent betas and was not reimplemented, presumably due to stability problems and bugs with the feature.

Apple File System is a more modern file system than HFS+ and is optimized for solid state drives. It is safe and secure, offering crash protection, safe document saves, stable snapshots, simplified backups, and strong native encryption.

Developers who happened to install APFS on their machines have been provided with instructions for how to convert back to HFS+ for the time being.

Apple's macOS High Sierra press release also confirms the company's plans to introduce APFS support for Fusion Drives and standard HDDs, but Apple has not offered a timeline on when we can expect the APFS update to be released.