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News

BioSpace
biospace.com > press-releases > tae-life-sciences-achieves-iso-13485-certification-marking-a-major-milestone-in-quality-and-regulatory-excellence

TAE Life Sciences Achieves ISO 13485 Certification, Marking a Major Milestone in Quality and Regulatory Excellence

3+ day, 4+ hour ago   (137+ words) Audit Concluded with Zero Findings, Underscoring the Company's Commitment to Patient Safety and Medical Device Quality A Defining Milestone for TAE Life Sciences The certification was awarded following a comprehensive audit conducted by BSI (British Standards Institution), a globally recognized…...

BioSpace
biospace.com > press-releases > imds-launches-nhanceit-microcatheter-in-the-u-s-to-advance-complex-pci

IMDS Launches NHanceIT™ Microcatheter in the U.S. to Advance Complex PCI

3+ day, 4+ hour ago   (211+ words) Proprietary Skeleton Backbone™ technology introduces a new approach to catheter design to address the growing complexity in coronary interventions Powered by proprietary Skeleton Backbone technology, NHanceIT maintains force transmission from hub to distal end. True 1:1 torque response and reinforced metal…...

BioSpace
biospace.com > press-releases > three-life-saving-medical-technologies-named-finalists-for-the-second-annual-thomas-j-fogarty-innovation-prize

Three Life-Saving Medical Technologies Named Finalists for the Second Annual Thomas J. Fogarty Innovation Prize

3+ day, 5+ hour ago   (335+ words) Statistics cookies help us to understand how visitors interact with websites by collecting and reporting information anonymously. Marketing cookies allow us to display more relevant ads that are engaging for our users and thereby, they are more valuable for publishers…...

BioSpace
biospace.com > press-releases > olympus-announces-new-class-of-itind-center-of-excellence-program-physicians

Olympus Announces New Class of iTind™ Center of Excellence Program Physicians

3+ day, 5+ hour ago   (457+ words) Program Aims to Advance Minimally Invasive Treatment of Enlarged Prostate CENTER VALLEY, Pa., Sept. 10, 2026 /PRNewswire/ -- Olympus Corp. of the Americas (Olympus) is pleased to announce the newest members of the iTind™ Center of Excellence (COE) Program, which is designed to…...

BioSpace
biospace.com > press-releases > retension-pharmaceuticals-appoints-leanne-bloedon-m-s-rd-as-evp-of-clinical-development-and-operations-and-kevin-schutz-pharmd-as-vp-regulatory-affairs

Retension Pharmaceuticals Appoints LeAnne Bloedon, M.S., RD, as EVP of Clinical Development and Operations, and Kevin Schutz, PharmD, as VP Regulatory Affairs

3+ day, 16+ hour ago   (140+ words) Statistics cookies help us to understand how visitors interact with websites by collecting and reporting information anonymously. Marketing cookies allow us to display more relevant ads that are engaging for our users and thereby, they are more valuable for publishers…...

BioSpace
biospace.com > press-releases > zeiss-announces-commercial-availability-of-bitoric-hydrophobic-monofocal-iol-the-zeiss-at-lucia-toric-721p

ZEISS announces commercial availability of bitoric hydrophobic monofocal IOL - the ZEISS AT LUCIA toric 721P

3+ day, 16+ hour ago   (224+ words) Statistics cookies help us to understand how visitors interact with websites by collecting and reporting information anonymously. Marketing cookies allow us to display more relevant ads that are engaging for our users and thereby, they are more valuable for publishers…...

BioSpace
biospace.com > press-releases > biolife-secures-u-s-patent-for-first-of-its-kind-effervescent-oral-peptide-delivery-technology

BioLife Secures U.S. Patent for First-of-its-kind Effervescent Oral Peptide Delivery Technology

3+ day, 16+ hour ago   (399+ words) PARIS--(BUSINESS WIRE)--BioLife today announced that the United States Patent and Trademark Office has granted U.S. Patent 12,667,605 B2 for its novel effervescent oral peptide delivery technology, designed to support current and future peptide therapeutics for obesity, diabetes and metabolic disease. The…...

BioSpace
biospace.com > business > encoded-raises-275m-series-f-for-dravet-syndrome-gene-therapy

Encoded raises $275M series F for Dravet syndrome gene therapy

3+ day, 18+ hour ago   (423+ words) Encoded Therapeutics has closed a $275 million series F round to help advance its investigational Dravet syndrome therapy into pivotal development. Much of the proceeds will go toward Encoded’s lead asset ETX101, according to a Wednesday release. The therapy is being tested…...

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biospace.com > fda > opinion-for-pdufa-viii-the-most-valuable-incentive-may-be-time

For PDUFA VIII, the most valuable incentive may be time

4+ day, 7+ hour ago   (506+ words) For a small biotech, the more practical incentive is time. Speed matters—whether a drug succeeds or fails. Finding out earlier that the biology is wrong stops further investment, limits unnecessary exposure of patients and allows scientists and resources to…...

BioSpace
biospace.com > press-releases > atman-health-wins-arpa-h-award-to-build-agentic-ai-for-cardiovascular-care-starting-with-heart-failure

Atman Health Wins ARPA-H Award to Build Agentic AI for Cardiovascular Care, Starting with Heart Failure

4+ day, 5+ hour ago   (122+ words) Access to cardiologists compounds the problem. A 2024 analysis in the Journal of the American College of Cardiology found that 1,454 of the 3,143 counties in the United States have no practicing cardiologist. Optimizing medications for millions of patients requires repeated clinical contact…...