RefleXion Seeks FDA Clearance for Anchor Point Tumor Tracking

Shots: The US FDA has received a 510(k) premarket notification for Anchor Point Tracking, a tumor tracking technology designed for use with its new RefleXion X2 radiotherapy platform Filing is backed by extensive system validation & phantom testing, with additional data from academic investigators demonstrating improved target tracking, dose conformity, motion management, & organ-at-risk sparing…

ByRidhi Rastogi8 hours ago

NEWS

Novocure Receives the CE Mark for Optune Pax with CT for Pancreatic Cancer

Shots: CE Mark was based on the P-III (PANOVA-3) trial assessing Optune Pax used concomitantly with gem/nab-pac (n=285), vs CT alone (n=286) in 571 adults with locally advanced pancreatic cancer, with launch expected in Germany in coming wks. Trial improved mOS to 16.2 vs 14.2mos. in ITT, with 1yr. survival of 68.1% vs 60.2%. In…

ByRidhi Rastogi12 hours ago

NEWS

Spotlight Medical Gains CE Mark for myStage Dx as an AI-Based Prognostic Test for ER+/HER2- Early Breast Cancer

Shots: Spotlight Medical has received CE marking under the EU IVDR for myStage Dx, an AI-enabled prognostic test designed to support risk stratification in patients with ER+/HER2- early breast cancer Test analyzes digitized H&E-stained FFPE pathology slides alongside routine clinicopathological variables to generate a binary prognostic classification of Low Risk or Not Low Risk In…

ByRidhi RastogiJune 24, 2026

EVENTS

HLTH Europe 2026: Key Highlights & Industry Insights

Shots • HLTH Europe 2026 brought together over 5,000 healthcare leaders, investors, policymakers, payers, providers, pharmaceutical executives, and digital health innovators in Amsterdam to explore the future of healthcare innovation. • Healthcare has a paradox: brilliant point solutions are failing not because they don't work, but because they can't talk to each other. A patient…

ByAditya SinghJune 22, 2026

NEWS

FiberSense Receives CE Mark for its Continuous Glucose Monitoring (CGM) System

Shots: FiberSense has received the CE Marking for its CGM System as a Class IIb medical device, with the company planning to launch in select markets, with initial orders confirmed & first deliveries expected in late 2026 The company is preparing manufacturing scale-up, logistics, customer support, & market access activities for launch, while advancing its…

ByRidhi RastogiJune 17, 2026

NEWS

SurGenTec Wins the US FDA Clearance for ION-L to Treat Degenerative Disc Disease

Shots: The US FDA has granted clearance to SurGenTec's ION-L Lumbar Facet Fixation System for the treatment of skeletally mature pts with degenerative disc disease (DDD) from L3 to S1 who have failed conservative care Clearance is supported by a multicenter, IRB-approved clinical study in a high-risk, real-world patient population, with independent radiographic reviews confirming…

ByRidhi RastogiJune 16, 2026

EVENTS

London Biotechnology Show 2026 | 18-19 November | Excel London

Get ready to connect with the innovators, investors, and industry leaders shaping the future of biotechnology at the London Biotechnology Show 2026. Taking place alongside London Life Sciences Week, the event is set to become one of the UK’s most influential gatherings for the global biotech and life sciences ecosystem. Bringing together 4,000+ attendees and…

BySaurabh ChaubeyJune 12, 2026

NEWS

Vara Secures CE Mark for AI-Powered Tomosynthesis Solution

Shots: Vara has received CE Class IIb marking under the EU MDR for its tomosynthesis (3D mammography) AI solution, expanding its offerings for breast cancer screening programs across the EU Vara is validated for national-scale breast cancer screening, with its scale demonstrated through PRAIM, a large prospective screening study published in Nature Medicine in 2025, supporting…

ByRidhi RastogiJune 10, 2026

NEWS

SpinaFX Receives the US FDA IDE Approval to Initiate Trial for Triojection Therapy

Shots: The US FDA has granted an IDE approval to Triojection therapy to initiate US trial in pts with contained herniated lumbar discs who have not responded to conservative therapy The trial is expected to enroll 300 pts across ~30 specialty spine centers, comparing intradiscal ozone/oxygen injection plus nerve root block against nerve root block…

ByRidhi RastogiJune 10, 2026

NEWS

Xenix Medical Reports the US FDA Clearance for Lux Expandable Lumbar Fusion System

Shots: Xenix Medical has received the US FDA 510(k) clearance & initiated the full commercial launch of its Lux Expandable Lumbar Interbody Fusion System Lux features up to 4.5mm of controlled post-implant expansion, enables bone graft delivery through the inserter into a large endplate-to-endplate graft window after expansion, & incorporates NanoACTIV surface tech. to support fusion…

ByRidhi RastogiJune 9, 2026

RefleXion Seeks FDA Clearance for Anchor Point Tumor Tracking

Novocure Receives the CE Mark for Optune Pax with CT for Pancreatic Cancer

Spotlight Medical Gains CE Mark for myStage Dx as an AI-Based Prognostic Test for ER+/HER2- Early Breast Cancer

HLTH Europe 2026: Key Highlights & Industry Insights

FiberSense Receives CE Mark for its Continuous Glucose Monitoring (CGM) System

SurGenTec Wins the US FDA Clearance for ION-L to Treat Degenerative Disc Disease

London Biotechnology Show 2026 | 18-19 November | Excel London

Vara Secures CE Mark for AI-Powered Tomosynthesis Solution

SpinaFX Receives the US FDA IDE Approval to Initiate Trial for Triojection Therapy

Xenix Medical Reports the US FDA Clearance for Lux Expandable Lumbar Fusion System

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