BioMedNewsBreaks

FridayJun 20, 2025 9:30 am

BioMedNewsBreaks — HeartBeam Inc. (NASDAQ: BEAT) Earns FDA Clearance for First Cable-Free ECG System for Arrhythmia Detection

HeartBeam (NASDAQ: BEAT) announced it has received FDA 510(k) clearance for its flagship ECG system, a first-of-its-kind, credit card-sized, cable-free device designed to deliver high-fidelity, three-directional cardiac recordings for arrhythmia evaluation. The clearance marks a major regulatory milestone and accelerates HeartBeam’s plans to improve access to timely, remote cardiac care. When symptoms arise, patients use the app-guided system to record a 30-second ECG, which is automatically uploaded to the cloud for physician review in the context of medical history. The company will soon launch an Early Access Program to engage early adopters and providers ahead of broader commercialization. This foundational…

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WednesdayJun 18, 2025 10:45 am

BioMedNewsBreaks – Intelligent Bio Solutions Inc. (NASDAQ: INBS) to Deploy Fingerprint Drug Testing System Across MWS Sites in Australia

Intelligent Bio Solutions (NASDAQ: INBS) announced that Managed Waste Service (MWS), a leading Australian waste management provider, will implement INBS’ Intelligent Fingerprinting Drug Screening System across its New South Wales operations. Covering over 20 remote land clearing and green waste sites, this marks MWS’s first shift to in-house, on-site drug testing for pre-employment, random, and for-cause purposes. The fingerprint-based system delivers non-invasive results in under ten minutes, enabling rapid safety decisions without disrupting field operations. INBS continues to expand its reach into safety-critical industries, with its scalable, sweat-based drug testing now in use by over 450 organizations across 24 countries.…

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WednesdayJun 18, 2025 9:30 am

BioMedNewsBreaks — HeartBeam Inc. (NASDAQ: BEAT) Secures Two New Patents Advancing 3D ECG and Cardiac Monitoring Technology 

HeartBeam (NASDAQ: BEAT), announced the issuance of two new U.S. patents that strengthen its intellectual property portfolio and support the company’s expansion in remote cardiac diagnostics. The new patents protect core technologies behind HeartBeam’s compact, cable-free 3D ECG device and its rhythm analysis algorithm capable of identifying arrhythmias through continuous signal input.  The 3D ECG device, which uses chest and finger electrodes to collect high-fidelity signals in three non-coplanar directions, is designed for on-demand symptom recording and 12-lead ECG synthesis. Its software is currently under FDA review, backed by data from the VALID-ECG pivotal study. The rhythm algorithm works across…

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WednesdayJun 18, 2025 9:20 am

BioMedNewsBreaks – Nutriband Inc. (NASDAQ: NTRB) Advances Aversa Fentanyl with Kindeva to Commercial Manufacturing Scale

Nutriband (NASDAQ: NTRB), a developer of prescription transdermal pharmaceutical products, announced the successful commercial manufacturing process scale-up of its lead product, Aversa™ Fentanyl, in collaboration with Kindeva, a global CDMO specializing in drug-device combinations. Aversa Fentanyl integrates Nutriband’s AVERSA™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch and is produced at Kindeva’s U.S.-based transdermal facility. The next step involves producing clinical supplies and submitting an Investigational New Drug application to begin a human abuse liability study. Nutriband projects Aversa Fentanyl, which aims to be the world’s first abuse-deterrent opioid patch, could achieve peak U.S. sales between $80 million and $200 million,…

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TuesdayJun 17, 2025 9:10 am

BioMedNewsBreaks – Intelligent Bio Solutions Inc. (NASDAQ: INBS) CEO Highlights Fingerprint Drug Testing on BioMedWire Podcast

Intelligent Bio Solutions (NASDAQ: INBS) CEO Harry Simeonidis joined the latest episode of The BioMedWire Podcast to discuss the company’s rapid, non-invasive drug screening platform and global expansion strategy. Simeonidis detailed how the company’s fingerprint-based technology detects drug use through sweat, enabling faster and more affordable workplace screening. With current deployments in about 20 countries and an FDA application under review, Intelligent Bio Solutions is targeting U.S. market entry in the second half of 2025 and expects to scale through distributor partnerships and targeted marketing. To view the full article, visit https://ibn.fm/qmoc6 About Intelligent Bio Solutions Inc. Intelligent Bio Solutions…

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TuesdayJun 17, 2025 9:00 am

BioMedNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) and AccurKardia Join Forces to Advance Remote Cardiac Monitoring

HeartBeam to integrate AccurECG(TM), AccurKardia’s FDA-cleared ECG analysis software Collaboration enhances HeartBeam’s commercial offering with automated arrhythmia insights Combined platform aims to improve cardiac care access and speed time to diagnosis HeartBeam (NASDAQ: BEAT) announced a strategic collaboration with AccurKardia, a leader in automated ECG diagnostics, to integrate its FDA-cleared AccurECG(TM) software into HeartBeam’s cable-free, credit card-sized 3D ECG device. The partnership unites two innovators in ambulatory cardiac monitoring to create a more scalable, accessible solution for arrhythmia detection and management. HeartBeam’s device captures electrical signals in three non-coplanar directions and synthesizes them into a 12-lead ECG for remote use.…

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MondayJun 16, 2025 10:21 am

BioMedNewsBreaks — Lantern Pharma Inc. (NASDAQ: LTRN) Reports Complete Response in Advanced NSCLC Patient in HARMONIC(TM) Trial

Lantern Pharma (NASDAQ: LTRN) announced a remarkable clinical outcome in its Phase 2 HARMONIC(TM) trial, with a 70-year-old never-smoker with advanced non-small cell lung cancer (NSCLC) achieving a durable complete response following treatment with LP-300 in combination with standard chemotherapy. The patient, who had previously failed three lines of therapy including Keytruda(R), radiation, and Tagrisso(R), initially saw a 57% tumor reduction and later achieved full resolution of lung and adrenal lesions. Nearly two years after treatment initiation, the patient remains progression-free and has experienced no clinically significant adverse reactions across 21 cycles. This sustained response underscores the potential of LP-300, developed…

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MondayJun 16, 2025 9:20 am

BioMedNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Forms Investor Relations Partnership With astr Partners

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, and its subsidiary HOPE Therapeutics announced a strategic investor relations partnership with astr partners, a boutique firm specializing in life sciences. The collaboration comes as NRx advances toward two NDA filings, an ANDA submission, and expands its interventional psychiatry clinic acquisitions. Led by veterans of The Trout Group, astr will support NRx and HOPE with investor targeting, message development, earnings prep, and institutional outreach to enhance visibility and engagement. To view the full press release, visit https://ibn.fm/orXqy About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on…

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MondayJun 16, 2025 9:00 am

BioMedNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) VALID-ECG Study Confirms Diagnostic Accuracy of Synthesized 12-Lead ECG

HeartBeam’s credit card-sized device demonstrated 93.4% diagnostic agreement with standard ECGs VALID-ECG study results presented at Heart Rhythm Society conference Company eyes U.S. commercialization pending FDA clearance HeartBeam (NASDAQ: BEAT) announced its synthesized 12-lead ECG met clinical endpoints in the VALID-ECG pivotal study, achieving 93.4% diagnostic agreement with standard ECGs for arrhythmia assessment. The findings, presented by Dr. Thomas Deering of Piedmont Heart Institute at the Heart Rhythm Society’s annual meeting in San Diego, validate HeartBeam’s compact, patient-friendly ECG technology. The study compared ECG intervals and amplitudes between HeartBeam’s synthesized output and simultaneously collected standard ECGs in 198 patients across…

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FridayJun 13, 2025 2:52 pm

BioMedNewsBreaks — HeartBeam Inc. (NASDAQ: BEAT) Reported Q1 2025 Results, Advanced Toward Commercialization Following VALID-ECG Study Success

HeartBeam (NASDAQ: BEAT) reported financial results and operational highlights for the first quarter of 2025, marking significant progress toward commercialization of its 12-lead ECG synthesis software. The company successfully met clinical endpoints in its VALID-ECG pivotal study, demonstrating a 93.4% diagnostic agreement with standard ECGs, and engaged in productive discussions with the FDA on its 510(k) submission. During the quarter, HeartBeam entered a strategic collaboration with AccurKardia to integrate its FDA-cleared AccurECG(TM) software into HeartBeam’s compact, cable-free cardiac device. The partnership was expected to accelerate product development and improve access to rapid arrhythmia diagnosis. The company also expanded its intellectual…

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