SAN MATEO, Calif. & NEW YORK–(BUSINESS WIRE)–Biograph study shows AI imaging detected coronary inflammation in 43% of asymptomatic adults, which standard blood tests failed to identify.
Regulatory
Teleflex Announces FDA Breakthrough Device Designation for Freesolve™ Resorbable Magnesium Scaffold
WAYNE, Pa.–(BUSINESS WIRE)–Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its Freesolve™ Resorbable Magnesium Scaffold (RMS) for percutaneous coronary intervention (PCI). To qualify for a BDD, device technology must address an unmet clinical need and show that it has the potential to provide for more effective treatment of life-threateni
Penumbra’s CAVT Technology Receives FDA Clearance for the Treatment of Deep Vein Thrombosis (DVT)
BOLT-DVT, a recent prospective, multicenter Investigational Device Exemption (IDE) trial, demonstrated first-line use of computer assisted vacuum thrombectomy (CAVT) for DVT is safe and effective ALAMEDA, Calif., Oct. 20, 2026 /PRNewswire/ — Penumbra, Inc. (NYSE: PEN), the world’s leading thrombectomy company, announced that the U.S. Food and Drug Administration (FDA) […]
Kardium Announces First Patient Enrollment in the Globe Registry, Expanding Real-World Evidence for the Globe® Pulsed Field System Following Strong Early Commercial Experience
VANCOUVER, British Columbia–(BUSINESS WIRE)–Kardium today announced the first site activation and first patient enrollment in the Globe Registry: Globe® Pulsed Field System Registry for Treating Patients with Symptomatic Atrial Fibrillation. The registry marks an important milestone in the continued commercial adoption of the Globe System following positive physician experience, strong procedural outcomes, and a growing body of evidence supporting the system’s unique integrated mapping and ab
Elucid Announces FDA Clearance of FFR-IQ™ and Commercial Availability of the Most Accurate¹ FFR-CT Software
BOSTON–(BUSINESS WIRE)– #510k–Elucid has received FDA 510(k) clearance of FFR-IQ™, its software for noninvasive estimation of fractional flow reserve from coronary CT angiography.
Vektor Medical Completes Enrollment in IMPRoVED-AF Clinical Study and Announces Appointment of Brandon Allen as Senior Vice President of Sales
SAN DIEGO–(BUSINESS WIRE)– #Medtech–Vektor Medical, a medical technology company advancing the treatment of cardiac arrhythmias through its non-invasive, AI-based arrhythmia analysis technology, vMap®, today announced the completion of patient enrollment in its IMPRoVED-AF randomized clinical study and the appointment of Brandon Allen as Senior Vice President of Sales. Together, these milestones mark important progress in Vektor’s efforts to expand commercial adoption of vMap and strengthen the clinica
Anteris Advances Global PARADIGM Trial Expansion with German Regulatory Clearance
MINNEAPOLIS and BRISBANE, Australia, Oct. 19, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) announced today that it has received full regulatory clearance from the German Federal Institute for Drugs and Medical Devices (BfArM) for the DurAVR® Transcatheter Heart Valve (THV) global pivotal trial for patients with severe calcific aortic stenosis (the “PARADIGM Trial”). This clearance enables Anteris to initiate patient recruitment at leading German centers and represents an important step in expanding the PARADIGM Trial’s European footprint. Germany is Europe’s largest and most established transcatheter aortic valve replacement (TAVR) market, with an extensive network of experienced structural heart centers and investigators. Activating sites in this high-volume environment is anticipated to increase access to eligible patients and accelerate enrollment in the PARADIGM Trial. “Germany’s scale, clinical expertise and established TAVR infrastructure create an important opportunity to advance enrollment and extend PARADIGM’s reach across leading international TAVR markets,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. The Company continues to execute its global clinical strategy through coordinated site activation and patient enrollment across the United States and Europe. Germany’s inclusion strengthens the trial’s European presence and adds meaningful scale to the PARADIGM Trial. ENDS About the PARADIGM Trial The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR® Transcatheter Heart Valve compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study will enrol approximately 1,000 patients in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure. For further information, please refer to ClinicalTrials.gov NCT07194265. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® THV, was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements, including statements regarding the expectation that this regulatory clearance enables patient recruitment in Germany. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. For more information: Global Investor Relationsinvestors@anteristech.comDebbie OrmsbyAnteris Technologies Global Corp.+61 1300 550 310 | +61 7 3152 3200Investor Relations (US)mchatterjee@bplifescience.comMalini Chatterjee, Ph.D. Blueprint Life Science Group+1 917 330 4269 Website www.anteristech.comX @AnterisTechLinkedIn https://www.linkedin.com/company/anteristech
Haemonetics Announces FDA Approval of PerQseal® Elite Vascular Closure System
BOSTON, Oct. 19, 2026 /PRNewswire/ — Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, today announced U.S. Food and Drug Administration (FDA) approval of the PerQseal® Elite vascular…
Jupiter Endovascular Announces Publication of SPIRARE II Pivotal Trial Results Showing Vertex Thrombectomy System Normalized Hemodynamics in 50% of Pulmonary Embolism Patients
MENLO PARK, Calif.–(BUSINESS WIRE)– #EuroIntervention–Jupiter Endovascular announced pivotal trial publication showing that its Vertex Thrombectomy System normalized hemodynamics in 50% of PE patients.
BioCardia Announces FDA Acceptance of De Novo Pre-Submission Package for Helix™ Catheter Marketing Clearance FDA Substantive Review and Meeting Expected this Quarter
SUNNYVALE, Calif., Oct. 19, 2026 (GLOBE NEWSWIRE) — BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the FDA has accepted its pre-submission package for marketing clearance of its Helix catheter (“Helix”) intended for therapeutic and diagnostic agent delivery. In May 2026, the Company and FDA met and reviewed our initial De Novo pre-submission package. FDA agreed that there are two pathways for Helix marketing clearance and raised no concerns regarding the product’s safety data, performance, or compatibility with general classes of agents. In August 2026, FDA confirmed and accepted the meeting minutes. In September 2026, the De Novo pre-submission was revised, incorporating the advice from FDA CDRH as detailed in the meeting minutes, re-submitted and has now been accepted by FDA. BioCardia expects FDA substantive review with written feedback, followed by a meeting with BioCardia to discuss approval via the De Novo pathway, this quarter. The extensive clinical data and safety profile from fifteen clinical trials including nearly five hundred patients presents an opportunity for FDA to ensure that follow-on catheters demonstrate a similar level of safety and clinical experience to obtain clearance. Marketing clearance of Helix by FDA has the potential to expand BioCardia’s opportunities to partner with developers of investigational cells, genes, and protein therapeutics requiring targeted delivery to the heart. About the Helix Transendocardial Delivery Catheter The Helix transendocardial delivery catheter is an enabling platform for minimally invasive targeted delivery of therapeutic and diagnostic agents to the heart intramyocardially. It enables agents to be delivered precisely within the heart with superior retention over other therapeutic delivery modalities, and to many regions of the heart that other delivery methods cannot reach. The Helix includes a specialized small distal helical needle which engages the heart tissue from within the chamber of the heart and provides stability within the dynamic beating heart to safely enable agent delivery. About BioCardia BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also acts as a biotherapeutic delivery partner supporting therapies for the treatment of heart failure, chronic myocardial ischemia, and acute myocardial infarction. Forward Looking Statements This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, the ability to enter into licensing and partnering arrangements, and overall market conditions. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2026, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. MEDIA CONTACT:Miranda Peto, Investor Relations mpeto@biocardia.com (650) 226-0120 INVESTOR CONTACT:David McClung, Chief Financial Officerinvestors@biocardia.com (650) 226-0120



