Collaboration pairs AtaCor’s investigational extravascular ICD lead with Abbott’s investigational extravascular ICD system to deliver potentially life-saving therapies AtaCor plans to initiate a pivotal Investigational Device Exemption (IDE) clinical trial in 2026 to evaluate the investigational extravascular implantable cardioverter defibrillator (EV-ICD) system This initiative furthers Abbott’s leadership in advancing next-generation […]
Rhythm
AliveCor Announces FDA Clearance of New Cardiac Determinations for Kardia 12L ECG System, Bringing Total to 39
KAI 12L, the AI powering Kardia 12L, adds five new detections to further expand diagnostic capabilities for the world’s first handheld 12-lead ECG with a unique single-cable design. KAI 12L, the AI powering Kardia 12L, adds five new detections to further expand diagnostic capabilities for the world’s first handheld 12-lead ECG with a unique single-cable design.
Kestra Medical Technologies Announces Strategic Collaboration with Biobeat Technologies to Expand Diagnostic Insight for Wearable Defibrillator Patients During Cardiac Recovery
KIRKLAND, Wash., Jan. 13, 2026 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a leading wearable medical device and digital healthcare company, today announced a strategic collaboration with Biobeat Technologies, Ltd. to expand diagnostic insight for patients prescribed the ASSURE® Wearable Cardioverter Defibrillator (WCD). The agreement is anchored by an exclusive license and co-development arrangement and includes a $5 million equity investment in Biobeat’s recently announced Series B financing. Biobeat has developed the only clinically validated, FDA-cleared cuffless, patch-worn ambulatory blood pressure monitoring (ABPM) device, leveraging photoplethysmography-based sensing to deliver continuous, noninvasive blood pressure measurement over a 24-hour period for hypertension diagnosis and management in the outpatient cardiac recovery setting. Kestra intends to integrate Biobeat’s technology into its product portfolio to make ABPM data available for patients prescribed the ASSURE WCD. Kestra recently published the largest prospective real-world study of wearable defibrillators to date and insights from ASSURE Wearable Cardioverter Defibrillator Clinical Evaluation Post-Approval Study (ACE-PAS) underscore the clinical relevance of the collaboration with Biobeat. Seventy-two percent (72%) of the patients studied in ACE-PAS were hypertensive, highlighting the complexity of managing blood pressure during cardiac recovery, particularly during guideline-directed medical therapy (GDMT) optimization. “Health care providers have consistently told us that better visibility to blood pressures during cardiac recovery would meaningfully support clinical decision making,” said Brian Webster, President and CEO of Kestra. “This collaboration allows us to expand the clinical insights available during recovery while reinforcing ASSURE as a flexible platform designed to support at-home patient care.” Arik Ben Ishay, CEO of Biobeat, added, “Kestra has built a scalable platform focused on protecting and supporting patients during cardiac recovery. We are excited to collaborate with Kestra as they explore how our FDA-cleared, 24-hour blood pressure monitoring for hypertension diagnosis may complement their Cardiac Recovery System® platform and expand the clinical insights available to care teams managing complex cardiac patients.” About Kestra Kestra Medical Technologies, Ltd. is a leading wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, please visit www.kestramedical.com. About BiobeatBiobeat is an innovative company with operations in Tel Aviv, Israel and Boca Raton, Florida. Biobeat is focused on revolutionizing the blood pressure monitoring landscape by expanding the use of ABPM for hypertensive patients and providing 24-hour blood pressure data that allows for patient comfort and uninterrupted sleep while capturing critical nighttime blood pressure measurements seamlessly and accurately. For more information visit https://www.bio-beat.com Forward-Looking StatementsExcept where otherwise noted, the information contained in this press release is as of January 13, 2026. Statements in this press release that express a belief, expectation or intention, as well as those that are not historical fact, are forward-looking statements. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions, and we cannot ensure that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following: risks related to our limited operating history and history of net losses; our ability to successfully achieve substantial market adoption of our products; competitive pressures; our ability to adapt our manufacturing and production capacities to evolving patterns of demand, governmental actions and customer trends; product defects or complaints and related liability; our ability to obtain and maintain adequate coverage and reimbursement levels for our products; our ability to comply with changing laws and regulatory requirements and resulting costs; our dependence on a limited number of suppliers; and other risks and uncertainties, including those described under the heading “Risk Factors” in Kestra’s Annual Report on Form 10-K for the fiscal year ended April 30, 2025 filed with the U.S. Securities and Exchange Commission (“SEC”) on July 17, 2025, and in other periodic reports filed by Kestra with the SEC. These filings are available on the Investor Relations section of our website at https://investors.kestramedical.com/ and on the SEC’s website at https://sec.gov/. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9f7a5dd8-eb80-4db2-b977-db8bba695bf8 CONTACT: Media contact
Rhiannon Pickus
rhiannon.pickus@kestramedical.com
Investor contact
Neil Bhalodkar
neil.bhalodkar@kestramedical.com
Biobeat Secures $50 Million Series B Financing to Advance Commercialization of its Patch-worn, Cuff-less 24-hour Ambulatory Blood Pressure Monitor
PETAH TIKVA, Israel & BOCA RATON, Fla.–(BUSINESS WIRE)–Biobeat Technologies, Ltd., developer of the first FDA-cleared, 24-hour ambulatory blood pressure monitoring (ABPM) system that is a patch-worn, cuff-less solution for diagnosis and treatment of hypertension, announced today the closing of a $50 million Series B equity financing. The time has arrived […]
Precision Redefined: LUMA Vision Completes VERAFEYE™ 4D-Guided Persistent AF Ablations, Demonstrating a Significant Advancement in Simplifying Image-Guided Cardiac Care
DUBLIN, Jan. 7, 2026 /PRNewswire/ — LUMA Vision Ltd., a leader in cardiac 4D navigation and imaging, today announced the successful completion of 15 VERAFEYE™-guided persistent atrial fibrillation (AF) ablation procedures conducted as part of a clinical study in collaboration with…
Stereotaxis Receives FDA Approval for MAGiC Ablation Catheter
ST. LOUIS, Jan. 06, 2026 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it obtained U.S. Food and Drug Administration (FDA) approval for the MAGiC™ Magnetic Interventional Ablation Catheter.
Abbott’s Volt™ Pulsed Field Ablation System Receives FDA Approval to Treat Patients with Atrial Fibrillation
Abbott’s Volt™ PFA System, the latest generation of cardiac ablation technology, is designed for people battling heart rhythm disorders such as atrial fibrillation (AFib) Pulsed field ablation – or PFA – is a minimally invasive procedure that uses high-energy electrical pulses in targeted…
ZOLL Launches Fifth-Generation LifeVest® WCD
CHELMSFORD, Mass.–(BUSINESS WIRE)–ZOLL®, an Asahi Kasei company that manufactures medical devices and related software solutions, announced the U.S. launch of the next generation LifeVest® wearable cardioverter defibrillator (WCD). This marks the fifth FDA-approved LifeVest WCD, which works seamlessly with the recently launched next generation LifeVest WCD garment, the most comfortable LifeVest […]
Pulse Biosciences Announces FDA IDE Approval to Initiate its nPulse Cardiac Catheter Ablation System Study for the Treatment of Atrial Fibrillation
HAYWARD, Calif.–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel nPulse™ technology using its proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) energy, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Company’s Investigational Device Exemption (IDE), allowing Pulse Biosciences to […]
Huxley Medical’s SANSA Receives Diagnostic ECG Clearance from FDA, Paving Way for First Solution to Systematically Detect Arrhythmias During Home Sleep Testing
ATLANTA, Dec. 18, 2025 /PRNewswire/ — Huxley Medical, Inc. announced the SANSA® home sleep apnea test has received regulatory clearance from the United States Food and Drug Administration (FDA) to be used as a diagnostic ECG monitor, making SANSA the first home sleep apnea test capable…



