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GE HealthCare’s StarGuide GX 4D SPECT/CT is designed for expanding theranostics workflows and emerging radionuclides including investigational alpha emitters. Representative image.
Features & Analysis

GE HealthCare designed StarGuide GX for the radiopharma boom. Is SPECT/CT becoming treatment infrastructure?

GE HealthCare has moved StarGuide GX toward the U.S. market as radiopharmaceutical therapy expands beyond conventional nuclear medicine. The 4D CZT SPECT/CT system is designed to image across a wide energy range, including investigational alpha emitters, highlighting how the theranostics boom is creating demand not just for drugs but for quantitation, dosimetry and workflow infrastructure.

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Medtronic’s FDA-cleared LigaSure RAS Maryland instrument expands the Hugo robotic-assisted surgery ecosystem with vessel-sealing technology used in more than 45 million procedures. Representative image.
Features & Analysis

Hugo has U.S. clearance, but Medtronic is still building its toolset. Why does LigaSure matter so much?

The FDA has cleared Medtronic’s LigaSure RAS Maryland instrument for the Hugo robotic-assisted surgery platform, bringing vessel-sealing technology used in more than 45 million procedures into U.S. robotic workflows. The milestone illustrates a less glamorous but commercially crucial reality of surgical robotics: hospitals buy ecosystems, not merely robots.

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Xenon Pharmaceuticals has submitted azetukalner for FDA approval in focal seizures while separately evaluating neuropsychiatric adverse events in its depression programmes. Representative image.
Features & Analysis

Azetukalner’s epilepsy NDA is backed by 1,500 patient-years. Do psychiatric adverse events change the regulatory equation?

Xenon Pharmaceuticals has submitted azetukalner for FDA approval in focal seizures after strong Phase 3 efficacy and more than 1,500 patient-years of epilepsy exposure. On the same day, the company paused new enrollment in psychiatry studies after neuropsychiatric adverse events emerged, creating a difficult question over how regulators and investors should interpret safety signals that

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Ultragenyx Pharmaceutical’s $3.95 million FAYUVI gene therapy is the first FDA-approved disease-modifying treatment for children with Sanfilippo syndrome type A. Representative image.
Features & Analysis

FAYUVI costs $3.95m for one infusion. Can Ultragenyx make the first Sanfilippo therapy accessible?

Ultragenyx Pharmaceutical has won FDA approval for FAYUVI, the first treatment designed to alter the course of Sanfilippo syndrome type A. The one-time AAV9 gene therapy carries a $3.95 million U.S. list price and will initially flow through specialist treatment centres, putting early diagnosis, payer access and preservation of neurodevelopmental function at the centre of

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Co-Diagnostics and ReadyGo begin feasibility work combining portable blood sample preparation with the Co-Dx PCR platform, using decentralized Ebola detection as the first test case. Representative image.
Medical Devices & Diagnostics

Co-Diagnostics and ReadyGo test decentralized blood PCR workflow starting with Ebola

Co-Diagnostics and ReadyGo have begun feasibility work combining portable blood sample preparation with the Co-Dx PCR platform, using decentralized Ebola detection as the first test case.

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ZBeats expands long-term cardiac monitoring after FDA 510(k) clearance for ZBPro Diagnostic v2.0 enables ECG analysis of continuous recordings lasting up to 14 days. Representative image.
Medical Devices & Diagnostics

FDA clears ZBeats software to analyze up to 14 days of ECG data across Holters and wearable patches

ZBeats has received FDA 510(k) clearance for ZBPro Diagnostic v2.0, expanding its ECG-analysis platform from short recordings to continuous datasets lasting as long as 14 days.

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Synergy Spine Solutions reports 87.1% composite clinical success for the FDA-approved Synergy Disc versus 56.6% with ACDF at two years in its U.S. cervical disc replacement IDE study. Representative image.
Medical Devices & Diagnostics

Synergy Disc beats cervical fusion on two-year composite success in U.S. IDE trial

Synergy Spine Solutions reports 87.1% composite clinical success with the FDA-approved Synergy Disc versus 56.6% with ACDF at two years in its U.S. IDE study.

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Sanofi is transferring mature medicines and manufacturing sites to Cheplapharm while retaining exposure through a 26.4% equity stake. Representative image.
Pharma & Biotech

Sanofi shifts 20 mature medicines and three factories to Cheplapharm for a 26.4% equity stake

Sanofi plans to transfer 20 mature medicines and manufacturing facilities in France, Hungary and Singapore to Cheplapharm while taking a 26.4% stake in the specialist pharmaceutical company.

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Intuitive Surgical’s latest evidence review compares da Vinci robotic surgery with laparoscopic and open procedures across millions of cases. Representative image.
Medical Devices & Diagnostics

Intuitive Surgical’s 14-million-case analysis strengthens da Vinci evidence but also exposes the economics debate

A meta-analysis covering more than 14 million procedures found several recovery advantages associated with da Vinci robotic surgery, while longer operating times and the study’s largely observational evidence base keep hospital economics central to the debate.

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Abbott’s Libre Duo combines continuous glucose monitoring with ketone detection to provide earlier warning of diabetic ketoacidosis risk. Representative image.
Medical Devices & Diagnostics

Abbott’s Libre Duo gets FDA authorization as continuous glucose monitoring expands into ketone detection

Abbott’s Libre Duo 10 Day has received FDA De Novo authorization as the first integrated continuous glucose and ketone monitoring system in the United States, potentially extending CGM from daily glucose control into early diabetic ketoacidosis warning.

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