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ESTA

Establishment Labs Holdings Inc. (NASDAQ:ESTA) announced the first U.S. commercial use of its Motiva Flora Tissue Expander at the University of Texas MD Anderson Cancer Center. The device, which recently received FDA clearance, features proprietary SmoothSilk surface technology and an RFID-enabled, non-magnetic port, making it MR conditional and reducing interference during radiation therapy. This marks a significant milestone for the company as it enters the U.S. market, the largest for breast reconstruction.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 1:10 pm

AAPL

Apple Inc. (NASDAQ:AAPL) did not release a new iPad in 2023, breaking a 12-year tradition of annual updates since the product's debut in 2010. The company's strategy may reflect changing consumer behavior and feedback on the iPad lineup's complexity. Analysts anticipate a significant hardware refresh for all iPad models in 2024, with rumors of six new models, including a 12.9-inch iPad Air and a feature-rich iPad Pro.

Portfolio Pulse from Benzinga Neuro

January 02, 2024 | 1:07 pm

VTAK

Catheter Precision, Inc. (NYSE:VTAK), a US-based medical device company, has been granted two new patents in Great Britain and the European Market for its LockeT product line. These patents complement an earlier patent issued in Japan in 2023, bolstering the company's intellectual property portfolio in the electrophysiology sector.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 1:03 pm

PLSE

Pulse Biosciences, Inc. has filed a 510(k) submission with the FDA for its CellFX nsPFA Cardiac Clamp, a technology aimed at treating atrial fibrillation.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 1:01 pm

AZN

SNY

China's National Medical Products Administration has approved AstraZeneca (AZN) and Sanofi's (SNY) Beyfortus, a drug for preventing respiratory syncytial virus (RSV) in infants. Beyfortus, a long-acting monoclonal antibody, is the first approved RSV prevention for a broad infant population and will be available for the 2024-2025 RSV season. The approval follows successful late-stage trials and previous approvals in the EU and by the FDA. AZN shares are down in premarket trading, while SNY's last close was at $49.73.

Portfolio Pulse from Vandana Singh

January 02, 2024 | 12:53 pm

BTTX

Better Therapeutics has submitted an application for FDA Breakthrough Device Designation for its digital therapeutic platform aimed at treating liver disease. This submission could expedite the review and approval process if granted, potentially benefiting patients with liver disease by providing a new treatment option.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 12:50 pm

LI

NIO

QQQ

SPY

TSLA

XPEV

U.S. stock futures are down on the first trading day of 2024, with investors cautious ahead of economic reports and Fed speeches. Crude oil prices rise due to geopolitical tensions, and cryptocurrencies surge. The Nasdaq and S&P 500 ended 2023 on a high, with the Nasdaq up 43% for the year. Analysts predict a strong year for tech stocks, particularly with AI advancements. The SPDR S&P 500 ETF Trust (SPY) and Invesco QQQ ETF (QQQ) are down in premarket trading. Tesla (TSLA) is in focus with its Q4 delivery report due, while Chinese EV makers Nio (NIO), XPeng (XPEV), and Li Auto (LI) see premarket declines despite strong delivery numbers.

Portfolio Pulse from Shanthi Rexaline

January 02, 2024 | 12:45 pm

THTX

Theratechnologies Inc. has submitted a supplemental Biologics License Application (sBLA) to the FDA for an intramuscular (IM) method of administering the maintenance dose of Trogarzo, a treatment for multidrug-resistant HIV-1 infection in adults. The new IM method aims to provide an alternative to the existing intravenous administration.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 12:34 pm

STRM

Streamline Health Solutions, Inc. (NASDAQ:STRM) has expanded its contract with a current client, a 6 facility health system using Oracle Cerner-EHR, to include RevID's automated charge reconciliation and the eValuator Pro Fee module. The client, which has been using eValuator for pre-bill code auditing for over 3 years, also extended the overall agreement term by an additional 3 years.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 12:33 pm

APCX

AppTech Payments Corp. (NASDAQ:APCX) has announced that Reno International Airport is the first international airport to implement its FinZeo platform for payment processing. The platform will handle all financial transactions within the airport. AppTech expects more airports to adopt FinZeo in the near future.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 12:32 pm