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NEWS

Galaxy Therapeutics Secures CE Mark for SEAL Embolization System

Shots: Galaxy has received CE Mark under the EU MDR 2017/745 for its SEAL Embolization System, following assessment by Notified Body DQS Medizinprodukte. Launch expected across selected EU markets, with FDA’s PMA application underway The SEAL Embolization System is an intrasaccular device for endovascular treatment of ruptured & unruptured wide-neck intracranial aneurysms, supporting aneurysm sizes…
August 4, 2026

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NEWS

Invenio Imaging Completes Enrollment in Pivotal ON-SITE Study for NIO Lung Cancer Reveal

Shots: Invenio has completed patient enrollment in the ON-SITE study evaluating NIO Lung Cancer Reveal, an AI-based image analysis module for rapid assessment of bronchoscopic lung biopsy specimens imaged with the NIO Imaging System The study enrolled 1,006 pts, involving >3,250 fresh biopsy specimens across 7 US medical centers, with specimens collected using transbronchial forceps biopsy,…
August 3, 2026

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NEWS

NIPRO Receives FDA 510(k) Clearance for ELISIO-HX Dialyzer for Expanded Hemodialysis in the US

Shots: NIPRO CORPORATION received US FDA 510(k) clearance for its ELISIO-HX dialyzer, enabling the US commercialization of HDs (Hemodialysis powered by super high-flux membrane). The clearance became effective on July 28, 2026 ELISIO-HX features NIPRO’s proprietary super high-flux membrane technology, designed to enhance the removal of larger middle-molecule uremic toxins while maintaining albumin retention. The…
July 31, 2026

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EVENTS

Global Pharma Partnering Summit 2026 | Nov 2–3, 2026 | Hyderabad, India

The pharmaceutical industry is entering a new era where innovation is no longer driven by individual organisations alone. From drug discovery and clinical research to manufacturing, regulatory compliance, digital transformation, and global commercialisation, success increasingly depends on strategic partnerships that combine expertise, technology, and shared ambition. The Global Pharma Partnering Summit 2026 serves as a…
July 31, 2026

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NEWS

Myriad Genetics Launches FirstGene Multi-Screen Prenatal Test in the US

Shots: Myriad Genetics has commercially launched FirstGene Multiple Prenatal Screen, combining four prenatal genetic screens in a single blood draw as early as 8wks. gestation FirstGene covers common chromosomal conditions, 19 recessive fetal conditions, 20 maternal carrier conditions, & fetal RhD status, with >98% analytical sensitivity & >99% specificity, and results available in ~10 days;…
July 22, 2026

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Personalis
NEWS

Tempus AI to Acquire Personalis for ~$1.5B

Shots: Tempus AI has entered into a definitive agreement to acquire Personalis, expanding Tempus' capabilities in minimal residual disease (MRD) As per the deal, Personalis shareholders will receive $16.25 per share, valuing the company at an enterprise value of $1.5B, net of Tempus AI’s existing ownership interest; closing expected in late 2026 or early 2027…
July 21, 2026

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NEWS

HoneyNaps Secures FDA Clearance for AI Sleep Diagnostic Software Somnum V3.0

Shots: The US FDA has granted 510(k) clearance to Somnum V3.0, an AI-based clinical decision support software to assist medical professionals in analyzing polysomnography data, incl. sleep staging & respiratory event detection Somnum V3.0 automatically detects apnea & hypopnea events, & classifies them as obstructive, central, or mixed sleep apnea. Validation data submitted to the…
July 16, 2026

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NEWS

SpinaFX Medical Secures CE Mark MDR Approval for Triojection System

Shots: SpinaFX has received MDR CE Mark for its Triojection System, which delivers a controlled ozone-oxygen gas mixture for procedures. Triojection also received US FDA’ IDE approval in Jun 2026 SpinaFX is engaging distribution partners to launch Triojection in priority markets, initially targeting pts with persistent pain from contained herniated discs who have failed conservative…
July 16, 2026

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NEWS

ElectroWire Medical Secures FDA 510(k) Clearance for LightningWire Transseptal System

Shots: The US FDA has granted 510(k) clearance to the LightningWire Transseptal Puncture System, indicated to create an atrial septal defect to enable the introduction of cardiovascular catheters LightningWire combines an electrosurgical guidewire & activation cable for transseptal access, working with preferred introducers & existing electrosurgical generators. Its insulation enables low-power puncture, while the 0.032-inch…
July 16, 2026

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