Medical Device – Talk Bio

Relation and Deerfield form NewCos to develop drugs from AI-discovered targets

2 days ago talkbio0Tagged AI drug discovery, Bone Diseases, Deerfield Management, Drug Delivery Systems, Immunology, Lab-in-the-Loop, Metabolic Diseases, newco, Platform, Relative (related person), royalties, strategic collaboration

Relation; Deerfield Management; strategic collaboration; NewCo; AI drug discovery; Lab-in-the-Loop platform; novel therapeutics; immunology; metabolic disease; bone disease; drug targets; royalties

Coloplast announces changes to Executive Leadership Team

3 weeks ago talkbio0Tagged Administration occupational activities, Anthropological Culture, Changing, coloplast, ELT, Executive Leadership Team, Interventional Urology, Johns, Kevin Hardage, Leadership, Persons, Transition Mutation

Coloplast; Executive Leadership Team; ELT changes; Interventional Urology; People & Culture; Kevin Hardage; Tommy Johns; leadership transition; management changes

Medivis First to Receive FDA Clearance for Augmented Reality Navigation in Neurosurgery

3 weeks ago talkbio0Tagged AR navigation, augmented, Clearance, Cranial Navigation platform, cranial neurosurgery, External Ventricular Drain, ICU bedside procedures, intraoperative guidance, Medivis, neurosurgery innovation, Spine Navigation, surgical intelligence, United States Food and Drug Administration

Medivis; FDA 510(k) clearance; augmented reality; AR navigation; cranial neurosurgery; intraoperative guidance; cranial navigation platform; external ventricular drain; ICU bedside procedures; surgical intelligence; spine navigation; neurosurgery innovation

SABCS 2025 Highlights: Celcuity’s Phase 3 VIKTORIA-1 Updates and Relay PI3K Inhibitor News

4 weeks ago talkbio0Tagged Celcuity, gedatolisib, Malignant neoplasm of breast, Phase 3, PI3 K inhibitors, PIK3CA gene, Relay Device, SABCS25, VIKTORIA-1, wild-type

SABCS25; Celcuity; VIKTORIA-1; gedatolisib; PIK3CA wild-type; Phase 3; breast cancer; Relay; PI3K inhibitors

Spotlight On: It’s Raining AI Devices as Regulatory Storm Reshapes Digital Health

1 month ago talkbio0Tagged 2025, Accountability, AI-enabled, clinical oversight, digital health regulation, digital mental health devices, draft guidance, EU, EU AI Act health, Generative AI, Health care facility, Medical Devices, Regulation, Software as a Medical Device, United States Food and Drug Administration

AI-enabled medical devices; digital health regulation 2025; FDA AI draft guidance; EU AI Act health; generative AI in healthcare; SaMD regulation; clinical oversight of AI; AI accountability in healthcare; digital mental health devices

Pluri Appoints Alejandro Weinstein as Chairman of the Board to Lead Strategic Shift and Unlock Value, Backed by Additional Investment

1 month ago talkbio0Tagged Alejandro Weinstein, Biotechnology, Boards (medical device), commercialization, Corporate, governance, Health care facility, Investments, M&A transactions, ownership increase, Pluri, strategic shift, Surgical construction, Zami Aberman

Pluri; Alejandro Weinstein; Chairman of the Board; strategic shift; additional investment; ownership increase; Zami Aberman; Vice Chairman; biotechnology; healthcare; M&A transactions; value creation; commercialization; corporate governance

Biotech interest shifting from obesity ‘halo’ to other areas like oncology and blood cancers

1 month ago talkbio0Tagged Autoimmune, biotech pivot, Halo brace, Investments, leukemia, Neoplasms, Novartis, Obesity, sector rotation

obesity drugs; biotech pivot; investment trends; Novartis; leukemia; obesity halo; sector rotation; autoimmune; oncology

Imfinzi Gains FDA Approval for Early Gastric and GEJ Cancers; BiomX Nebulizer Faces FDA Scrutiny

1 month ago talkbio0Tagged Approved, BiomX, Clinical, Imfinzi, Malignant neoplasm of cardioesophageal junction of stomach, Malignant neoplasm of stomach, Nebulizers, perioperative, United States Food and Drug Administration

Imfinzi; FDA approval; gastric cancer; gastroesophageal cancer; perioperative; BiomX; nebulizer; clinical hold

Curapath and Cristal Therapeutics Sign Co-Exclusive License of CliCr Bioconjugation Platform

1 month ago talkbio0Tagged Bioconjugation Platform, CDMO, CliCr, co-exclusive license, Cristal Therapeutics, Curapath, Drug Delivery Systems, nucleic acid delivery

Curapath; Cristal Therapeutics; CliCr Bioconjugation Platform; co-exclusive license; nucleic acid delivery; CDMO; drug delivery

EDAP Receives FDA 510(k) Clearance for Advanced Focal One Robotic HIFU System Enhancements

2 months ago talkbio0Tagged algorithm, Clearance, Edap, Malignant neoplasm of prostate, Medical Devices, robotic HIFU, United States Food and Drug Administration

EDAP; FDA 510(k) clearance; Focal One; robotic HIFU; high intensity focused ultrasound; ultrasound imaging; prostate cancer treatment; AI algorithms; medical devices