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NEWS

Zeto Receives US FDA 510(k) Clearance for Zeto New Wave to Advance Outpatient EEG

Shots: The US FDA has granted 510(k) clearance to Zeto New Wave to perform EEG efficiently in outpatient clinics & homes Zeto New Wave is an easy-to-use outpatient EEG system with 21 soft-tip electrodes (10–20 system), offering full head coverage & paired with a compact device capturing synchronized video/audio  Designed for short-term recordings up to 2.5hrs., the…
April 3, 2026

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NEWS

JenaValve Launches Trilogy Transcatheter Heart Valve System in the US to Treat Symptomatic, Severe Aortic Regurgitation (ssAR)

Shots: JenaValve Technology has launched Trilogy THV System to treat ssAR in pts at high or greater surgical risk & reported successful first cases across the US The System uses radiopaque locators to attach directly to native aortic leaflets without calcification, allowing stable implantation, precise alignment, reduced paravalvular regurgitation, & preserving future coronary access with…
April 2, 2026

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NEWS

Elidah Reports US FDA Clearance of Elitone for Men to Treat Post-Prostatectomy Urinary Incontinence

Shots: The US FDA has granted clearance to Elitone for Men to help restore bladder control after prostate surgery, with US availability expected in Apr 2026 Elitone for Men is a non-invasive, at-home therapy that delivers neuromuscular stimulation to strengthen pelvic floor muscles, improving bladder control, with a simple 20min. daily use enabling consistent treatment…
April 1, 2026

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NEWS

Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Pulmonary Hypertension Early

Shots: The FDA has granted 510(k) clearance to an AI-enabled PH algorithm, a software-as-a-medical-device designed to detect early signs of PH, cleared for use with standard 12-lead ECGs The PH algorithm detects subtle early PH patterns in standard 12-lead ECGs & integrates with EHR & ECG management systems, plus it operates entirely within the health…
March 30, 2026

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EVENTS

UK Biotech Day 2026 | May 27-28 | London, UK

UK Biotech Day is a leading event for the UK life sciences sector, bringing together executives and R&D scientists from pharma, biotech, medtech, techbio, investors, lawyers, patent attorneys, CROs, CDMOs, accountants, bankers, executive search agencies, and more. Serving as a global gateway, the event connects the UK ecosystem with international partners to drive strategic collaborations…
March 30, 2026

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Novocure
NEWS

Novocure Reports Topline P-II (PANOVA-4) Trial Data on TTFields Therapy for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

Shots: Novocure reported P-II (PANOVA-4) trial data evaluating Tumor Treating Fields (TTFields) with Tecentriq & gemcitabine/nab-paclitaxel as a 1L treatment for mPDAC, with a median TTFields duration of 25.6wks. & median systemic therapy duration of 6 cycles Trial met its 1EP, showing a DCR of 74.4% in TTFields group (N=78) vs 48% with gem/nab-pac alone…
March 26, 2026

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NEWS

Kallisio’s Stentra Receives CE Mark for Precision Oral Immobilization System in Head & Neck Radiation Therapy

Shots: Kallisio has received CE certification under the EU MDR 2017/745 for its Stentra intraoral positioning system, with initial deployment planned through selected clinical pilot sites in Germany Stentra is a patient-specific intraoral device designed to support precise positioning & stabilization during head & neck radiation therapy, integrating seamlessly into existing workflows without requiring changes…
March 26, 2026

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NEWS

Pixee Medical’s Knee+ NexSight Receives the European CE Mark for Knee Arthroplasty

Shots: Pixee Medical has received CE mark for Knee+ NexSight, its AR-based total knee arthroplasty solution, with initial procedures completed in EU & a 510(k) submission under FDA review Knee+ NexSight projects a virtual display with voice control during knee arthroplasty, without the need for a robot, console, or disposables, while delivering robotic-level accuracy with…
March 25, 2026

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NEWS

JenaValve’s Trilogy Transcatheter Heart Valve System Secures FDA Approval for Symptomatic, Severe Aortic Regurgitation (ssAR)

Shots: The US FDA has granted PMA approval to the Trilogy THV System to treat ssAR in pts at high or greater surgical risk, with immediate launch planned via participating study sites, followed by hospitals across the US Approval was supported by the results from ALIGN-AR pivotal IDE trial assessing safety & efficacy of the…
March 19, 2026

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