Streetbeat News

Regulatory

IINN

Inspira Technologies (NASDAQ:IINN) has signed a non-binding Letter of Intent with Northwestern Memorial Hospital for the clinical use of its INSPIRA ART100 device, pending FDA clearance. The collaboration will involve Northwestern purchasing disposables for the device and providing usage data to Inspira Technologies. The agreement is contingent on FDA approval expected in the first half of 2024 and a definitive evaluation agreement.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 1:37 pm

DXR

Daxor Corporation has submitted its new Blood Volume Analyzer (BVA) system to the FDA for clearance, with expectations for potential approval in the first half of 2024. The new BVA system is designed to deliver faster, simpler, and bedside results, aligning with the company's mission to improve healthcare through optimal fluid management.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 1:33 pm

ADTX

Aditxt, Inc. has regained compliance with the Nasdaq's minimum stockholders' equity requirement, ensuring its continued listing on the stock market.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 1:31 pm

CHRS

Coherus BioSciences, Inc. (NASDAQ: CHRS) has launched LOQTORZI, the first and only FDA-approved treatment for nasopharyngeal carcinoma (NPC) in all lines of therapy. LOQTORZI is now available through select specialty distributors and is indicated for use in combination with chemotherapy for first-line treatment and as monotherapy for patients with disease progression after platinum-containing chemotherapy. The launch follows positive results from the JUPITER-02 and POLARIS-02 studies, which showed significant improvements in progression-free survival and overall survival. Coherus aims to make LOQTORZI the new standard of care for NPC and is committed to supporting patients with programs to reduce out-of-pocket costs.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 1:31 pm

VIASP

Trading for VIASP was halted and then resumed at 8:30 AM ET, with updated status including news and resumption times.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 1:30 pm

VIA

Trading for VIA has been halted and then resumed at 8:25 AM ET, with updated quotation resumption times following the release of news.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 1:25 pm

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

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

ASML

ASML shares are trading lower following the Dutch government's partial revocation of a license for the shipment of NXT:2050i and NXT:2100i lithography systems.

Portfolio Pulse from Benzinga Newsdesk

January 02, 2024 | 12:55 pm