<div>
  <p>
  </p>
  <ul>
    <li>
      <p>
        The US Food and Drug Administration (FDA) has approved a software update that allows Apple's AirPods Pro 2 to function as over-the-counter hearing aids.
      </p>
    </li>
    <li>
      <p>
        The FDA authorization follows Apple's announcement of a new hearing aid feature for the second-generation AirPods Pro, describing it as &quot;the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature.&quot; The feature was evaluated in a clinical study with 118 subjects with mild to moderate hearing loss, demonstrating similar perceived benefits as professional fitting of the same device.
      </p>
    </li>
    <li>
      <p>
        This development is part of Apple's focus on hearing health, including a new Hearing Protection mode and a Hearing Test feature for AirPods Pro owners.
      </p>
    </li>
    <li>
      <p>
        <b>Analyst QuickTake: </b>
        In 
        <a href="https://sp-edge.com/updates/23600">
          November 2023
        </a>
        , Soundwave Hearing obtained FDA 510k clearance for Sontro, its OTC hearing aids. While Soundwave&rsquo;s hearing aids are designed specifically to be hearing aids, Apple&rsquo;s AirPods are considered the first wireless earbuds that have also been cleared as FDA-approved hearing aids.
      </p>
    </li>
  </ul>
  <p>
  </p>
</div>


<div>
  <p>
    <a href="https://techcrunch.com/2024/09/12/apple-airpods-pro-granted-fda-approval-to-serve-as-hearing-aids/">
      TechCrunch
    </a>
  </p>
  <p>
    <a href="https://www.theverge.com/2024/9/12/24242929/apple-airpods-pro-hearing-aids-fda-authorization">
      The Verge
    </a>
  </p>
</div>


Age Tech

ANALYST_QUICK_TAKE

INCUMBENTS_PRESENT

<div>
 
 <p>The US Food and Drug Administration (FDA) has sanctioned a software update enabling Apple's AirPods Pro 2 to serve as over-the-counter hearing aids.</p>
 <p>Post Apple's announcement of a novel hearing aid feature for the second-generation AirPods Pro, the FDA approval followed. Apple deemed it as "the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature." In a clinical study encompassing 118 subjects with mild to moderate hearing impediments, the feature exhibited comparative perceived benefits similar to professional fitting of the identical device.</p>
 <p>Such advancement aligns with Apple's commitment to hearing health. It has also introduced a new Hearing Protection mode and a Hearing Test feature for AirPods Pro users.</p>
 
</div> <p><b>Analyst QuickTake:<br>
 </b> In <a href="https:<br>
//sp-edge.com/updates/23600"> November 2023 </a> , Soundwave Hearing obtained FDA 510k clearance for Sontro, its OTC hearing aids. While Soundwave’s hearing aids are designed specifically to be hearing aids, Apple’s AirPods are considered the first wireless earbuds that have also been cleared as FDA-approved hearing aids.</p>

FDA approves Apple AirPods Pro as over-the-counter hearing aids

Reinforcing recycling, rerouting refuse, and reducing wasteflows

Waste Recovery & Management Tech

PROMINENT_CATEGORY

<div>

<p>Intuitive AI, an AI development company, has teamed up with Moda Center, the home of the Portland Trail Blazers basketball team, to launch Oscar Sort, an AI-powered recycling assistant. According to the partners, Oscar Sort uses AI to identify compostable, recyclable, and reusable items, guiding fans to dispose of waste correctly. The technology's goal is to enhance sustainability, improve waste diversion, and provide valuable data for operations optimization.</p>
<p>The collaboration is set to support Moda Center's Rip City Reuse program, which replaces 500,000 single-use cups per year with reusable ones. The Oscar Sort technology also reportedly provides management with real-time data on waste disposal trends and bin volumes, which could lower operational costs and create new revenue streams.</p>

</div>

Intuitive AI partner with Moda Center to implement Oscar Sort recycling technology

Membership-based, non-insurance healthcare companies helping maintain a steady state of well being.

Preventive Healthcare

<div>
 <p>Minze Health, a provider of digital health solutions, has secured USD 5.3 million in funding. The investment round was led by White Fund, Capricorn Digital Growth Fund, and PMV, with additional contributions from the imec.istart future fund.</p>
 <p>The funding will be harnessed for the expansion and commercialization of their digital therapeutics for urinary dysfunctions in the German and French markets. Additionally, the funds will be used to drive entry into the US market with at-home diagnostic solutions such as Homeflow and Diary Pod.</p>
 <p>To further facilitate their US expansion, Minze Health has appointed Drew Moore as the vice president of marketing and sales. With over two decades of experience in the marketing of digital healthcare and medical device products, Moore has specific expertise in the urology sector.</p>
</div> <p><b>Analyst QuickTake:<br>
</b> In recent months, the remote monitoring sector has seen notable funding activity. In September 2024, <a href="https:<br>
//sp-edge.com/updates/33938"> Orpyx </a> raised USD 20 million to accelerate the commercialization of its solutions. In August, <a href="https:<br>
//sp-edge.com/updates/32565"> Aevice Health </a> secured USD 7 million to expand operations in the US, Japan, and Singapore, while <a href="https:<br>
//sp-edge.com/updates/32749"> Know Labs </a> raised approximately USD 1.7 million to fund product development. <a href="https:<br>
//sp-edge.com/updates/32018"> CoachCare </a> raised USD 48 million in July to drive its expansion, followed by <a href="https:<br>
//sp-edge.com/updates/28136"> Movano Health </a> raising USD 24 million in April to support its operational needs.</p>

Minze Health raises USD 5.3 million in funding for product and market expansion; appoints new VP

Technology to explore opportunities beyond Earth

Space Travel and Exploration Tech

<div>
 <p>Space transportation company, Firefly Aerospace, and defense technology firm, True Anomaly, have formed a partnership for rapid-response space launches, which includes three missions using Firefly's Alpha rocket. The first mission is planned for 2025 and will launch True Anomaly's Jackal Autonomous Orbital Vehicle for the US Space Force's VICTUS HAZE Tactically Responsive Space mission, which will demonstrate rapid-response capabilities for orbital operations.</p>
 <p>This partnership draws on Firefly's prior experience with the Space Force's VICTUS NOX mission in <a href="https://sp-edge.com/updates/21944"> September 2023 </a>. The partnership is intended to enhance both companies' standing in the military's rapid-response space operations sector by undertaking two more missions between 2025 and 2027.</p>
</div> <p><b>Analyst QuickTake:<br>
 </b> Firefly Aerospace signed a multi-launch agreement with L3Harris Technologies in <a href="https:<br>
//sp-edge.com/updates/32472"> August 2024 </a> for 20 launches on the Alpha rocket, including two to four missions per year from 2027 to 2031. Firefly also recently partnered with <a href="https:<br>
//sp-edge.com/updates/34008"> NASA </a> to provide launch services for the National Oceanic and Atmospheric Administration's QuickSounder mission under the VADR contract.</p>

Firefly Aerospace partners with True Anomaly for Space Force rapid-response mission launches

Bringing the benefits of blockchain to the enterprise

Enterprise Blockchain Solutions

<div>
 <p>zkPass, a protocol that preserves data privacy, has garnered a total of USD 15 million in funding with its Series A funding round contributing USD 12.5 million. The funding round was led by a network of investors including dao5, Animoca Brands, Flow Traders, Amber Group, IOBC Capital, Signum Capital, MH Ventures, and WAGMI Ventures, resulting in a token valuation of USD 100 million for zkPass.</p>
 <p>The firm has plans for expansion, looking to increase their employee base from 26, focusing on positions in engineering, marketing and business development.</p>

</div>

zkPass raises USD 12.5 million in Series A funding

Incorporating technology to improve efficiency and success rate of clinical trials

Clinical Trial Technology

<div>
 
 <p>Ontada, a McKesson oncology technology business, is collaborating with Microsoft to utilize Azure AI for processing unstructured oncology data.</p>
 <p>Through this partnership, Azure's OpenAI Service will be employed to efficiently handle over 150 million unstructured oncology document components. An expected outcome is the improvement of data quality and accuracy, resulting in a more in-depth view of the patient's health journey. This approach is anticipated to enhance patient outcomes and the quality of oncology care. The joint venture will use Ontada's ON.Genuity platform, which integrates AI with a common data model to produce real-world data from its unique electronic health record, iKnowMed.</p>
 <p>Ontada, being a data science and technology firm focused on oncology, aims to better the lives of cancer patients. As a subsidiary of McKesson Corporation, Ontada gains insights from real-world data and evidence generation, thereby fast-tracking life science research. It offers clinical and operational technology that aids community providers in providing precise care. Additionally, the company offers provider engagement channels that facilitate insights and support treatment education programs.</p>
 
</div>

Ontada partners with Microsoft to process unstructured oncology data using Azure AI

A booming food and beverage segment with a history as rich and varied as its present-day product offerings

Plant-based Dairy & Egg

<div>
 <p>Burcon NutraScience Corporation has introduced Puratein, a canola protein isolate created to substitute eggs in the food industry. The product targets manufacturers who are in search of sustainable egg alternatives due to supply problems and price increases. </p>
 <p>Puratein, which possesses more than 90% protein purity, can serve as a replacement for 100% powdered and shelled eggs in different baked products. The product is said to have a complete amino acid profile, high solubility, and neutral taste, thereby making it appropriate for numerous food and beverage applications. </p>
 <p>Furthermore, Burcon suggests that Puratein can offer cost reductions of 20% to 30% compared to conventional egg products. The company asserts that the product fulfills the functional needs of egg substitutes. Simultaneously, it caters to the increasing consumer interest in plant-based alternatives. </p>
</div>

Burcon unveils canola protein isolate for egg replacement

Making meat sustainable over the long term

Cell-cultured Meat

<div>
 <p>Czech-based company, Bene Meat Technologies, has announced the creation of its first cultivated burger patty for people to consume. The firm asserts that the burger will have a similar price to high-quality beef.</p>
 <p>The production of the burger involves a traditional cell cultivation method, which begins with obtaining cell tissue or sourcing from a cell bank. The company formulates its media recipes and machinery internally, thereby dodging costly ingredients and intricate procedures. The burger purportedly consists of nearly 90% cultivated beef cells, with the remaining made up of spices and less significant ingredients.</p>
 <p>According to Bene Meat Technologies, its dedication to cost-efficient and scalable production has helped it match the price of premium beef. Currently, the company is building a larger facility estimated to produce roughly 200 tons of their product annually, with completion expected in 2025.</p>
 </div> <p><b>Analyst QuickTake:<br>
 </b> The price premium of cultivated meat products is a major consumer pain point deterring mass adoption. This has led companies to develop innovative cost-reduction methods such as FBS-free alternatives and novel production methods. In <a href="https:<br>
//sp-edge.com/updates/11598"> July 2022 </a> , SciFi Foods achieved an R&amp;D milestone that reportedly allowed the company to reduce the cost of growing beef cells by more than 1,000x and achieve price parity.</p>

Bene Meat Technologies produces first cultivated burger at parity with premium beef

A new wave of meat, fish, and poultry alternatives are driving this hyper-growth industry into the mainstream

Plant-based Meat

<div>
 <p>The Better Meat Co. (BMC), a California-based alternative protein company, has received approval from the Singapore Food Authority to sell its flagship Rhiza mycoprotein in Singapore. This approval allows BMC to introduce its innovative mycoprotein to the Singaporean market, potentially leading to wider Asian distribution. The expansion is in line with the company's aim of providing sustainable and nutritious meat alternatives or enhancers.</p>
</div> <p><b>Analyst QuickTake:<br>
 </b> In <a href="https:<br>
//sp-edge.com/updates/31400"> July 2024 </a> , BMC received the FDA's "no questions" letter, confirming Generally Recognized as Safe (GRAS) status for Rhiza, making this the second regulatory approval secured by the company during the year. Rhiza is a single-ingredient product made from Neurospora crassa, a fungi genus used in BMC's biomass fermentation process.</p>

The Better Meat Co. expands to Asia with Singapore approval for Rhiza mycoprotein

Autonomous and connected technologies shaping the future of the auto industry

Auto Tech

<div>
 <p>Self-driving vehicle technology company, Pony.ai, which is based in China and the US, has filed for an initial public offering (IPO) in the US. The company plans to list on the Nasdaq using the ticker symbol “PONY.”</p>
 <p>In the first half of 2024, the company doubled its revenue to USD 24.7 million whilst reporting a net loss of USD 51.3 million for the same period. This is an improvement from a net loss of USD 69.4 million in the first half of 2023.</p>
 <p>The company currently operates a fleet of over 250 robotaxis and has reached 20.8 million miles of autonomous driving. This includes 2.4 million miles of fully-autonomous driverless mileage.</p>
</div> <p><b>Analyst QuickTake:<br>
 </b> The influx of Chinese firms seeking US stock market listings has dwindled in recent years following <a href="https:<br>
//www.scmp.com/business/banking-finance/article/3161307/days-after-go-ahead-vie-structures-beijing-releases"> Beijing's 2021 tightened restrictions </a> on overseas fundraising activities. However, Pony.ai <a href="https:<br>
//sp-edge.com/updates/28771"> got approval </a> from Chinese securities for a US IPO in April 2024. Chinese regulators have also allowed autonomous vehicle tech firms like <a href="https:<br>
//sp-edge.com/updates/32038"> WeRide </a> and <a href="https:<br>
//www.businesstimes.com.sg/startups-tech/china-approves-autonomous-driving-startup-momentas-us-ipo"> Momenta </a> to list in the US market.</p>

Pony.ai files for US IPO

New data privacy regulations have opened up space for a new wave of compliance-focused startups.

Digital Privacy Tools

<div>
 <p>MineOS has updated its data governance and privacy platform with the release of Data Subject Request (DSR) Management 2.0. This upgrade introduces the no-code Infinite Integration Builder, which enables organizations to customize integrations with various backend systems, platforms, and Software as a Service (SaaS) applications.</p>
 <p>The new tool provides a no-code solution for organizations to streamline the integration with their data ecosystems. Notable improvements include enhanced automation features, customized rights flow based on geography, an improved ticket flow page, and a revamped approach to API connections.</p>
 <p>According to MineOS, this update simplifies the deployment and maintenance of automated DSR handling, making the process more efficient for businesses. The company also claims quick implementation of the platform within a matter of days, rendering expensive professional services and long implementation periods unnecessary.</p>
</div>

All Updates

FDA approves Apple AirPods Pro as over-the-counter hearing aids

Intuitive AI partner with Moda Center to implement Oscar Sort recycling technology

Minze Health raises USD 5.3 million in funding for product and market expansion; appoints new VP

Firefly Aerospace partners with True Anomaly for Space Force rapid-response mission launches

zkPass raises USD 12.5 million in Series A funding

Ontada partners with Microsoft to process unstructured oncology data using Azure AI

Burcon unveils canola protein isolate for egg replacement

Bene Meat Technologies produces first cultivated burger at parity with premium beef

The Better Meat Co. expands to Asia with Singapore approval for Rhiza mycoprotein

Pony.ai files for US IPO

MineOS launches DSR management 2.0

Age Tech

FDA approves Apple AirPods Pro as over-the-counter hearing aids

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