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 Rastogi1 day ago

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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 Rastogi1 day ago

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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 Rastogi2 days ago

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Novanta to Acquire Riverpoint Medical in ~$1.45B Deal

Shots: Novanta has entered into a definitive agreement to acquire Riverpoint Medical from Arlington Capital Partners, expanding Novanta’s presence in the minimally invasive surgery market As per the deal, Novanta will acquire Riverpoint for $1.2B upfront, with $250M in milestone payments expected in Q1’27, representing the total deal value of $1.45B; closing is anticipated in…

ByRidhi Rastogi2 days ago

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Signati Medical Receives FDA IDE Approval for Pivotal Trial of Separo Vasectomy System

Shots: The FDA has granted IDE approval to initiate a multi-center pivotal study evaluating the Separo Vessel Sealing System vs standard mucosal cautery vasectomy The trial will enroll 120 adult male subjects across ~5 US centers, with the primary endpoint measuring azoospermia or rare non-motile sperm (≤100,000/mL) within 6mos. following the procedure The Separo System…

ByRidhi RastogiJune 3, 2026

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NeuroPace Receives the US FDA Approval for ECoG Assistant to Advance AI-Driven Epilepsy Care

Shots: The US FDA has approved ECoG Assistant, an AI-powered clinician tool designed to support epilepsy management using data from the RNS System, with NeuroPace debuting the tool at ASSFN’26 ECoG Assistant was developed using 124,450 epileptologist-labeled intracranial EEG records & identifies ECoGs of Interest, enabling clinicians to review long-term EEG trends & circadian activity…

ByRidhi RastogiJune 1, 2026

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Cardiosense Receives FDA De Novo Classification for its PCWP Analysis Software

Shots: The FDA has granted De Novo classification to Cardiosense's PCWP Analysis Software to noninvasively estimate pulmonary capillary wedge pressure (PCWP) in adults with heart failure with reduced ejection fraction (HFrEF), incl. those with LVEF ≤40% & NYHA Class II, III & IV symptoms The Software integrates its CardioTag wearable sensor with AI to…

ByRidhi RastogiMay 28, 2026

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Myriad Genetics Launches Prolaris + AI Test for Personalized Prostate Cancer Active Surveillance

Shots: Myriad Genetics to launch the Prolaris + AI Test, with the new AI metric available for all Prolaris Biopsy Tests in the US from May 29, 2026 excl. New York; approval in NY is expected soon A validation study of 998 pts for model training & 296 pts for validation, demonstrated that AI-GUR independently…

ByRidhi RastogiMay 27, 2026

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TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Alzheimer’s Disease Test

Shots: The US FDA has granted BDD to the TOBY Test for diagnosing Alzheimer’s disease in adults (≥50yrs.) with signs and symptoms of cognitive impairment undergoing evaluation for Alzheimer’s disease The TOBY Test is a non-invasive urine-based diagnostic designed to aid Alzheimer’s disease diagnosis by analyzing urinary volatile organic compound patterns using mass spectrometry and…

ByRidhi RastogiMay 27, 2026

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Oticon Medical Launches Ponto Instant Portfolio to Expand Non-Surgical Bone Conduction Hearing Options

Shots: Oticon Medical has launched Ponto Instant, a non-surgical bone conduction hearing portfolio, adding Instant HearBand & Instant SoundConnector to expand wearable options for children & adults Instant HearBand is a lightweight behind-the-head wearable alternative to Softband 5 with customizable sizing, while Instant SoundConnector attaches sound processors to headwears, offering an additional option for lifestyle…

ByRidhi RastogiMay 26, 2026

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

Novanta to Acquire Riverpoint Medical in ~$1.45B Deal

Signati Medical Receives FDA IDE Approval for Pivotal Trial of Separo Vasectomy System

NeuroPace Receives the US FDA Approval for ECoG Assistant to Advance AI-Driven Epilepsy Care

Cardiosense Receives FDA De Novo Classification for its PCWP Analysis Software

Myriad Genetics Launches Prolaris + AI Test for Personalized Prostate Cancer Active Surveillance

TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Alzheimer’s Disease Test

Oticon Medical Launches Ponto Instant Portfolio to Expand Non-Surgical Bone Conduction Hearing Options

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