Shots:
Organogenesis has reported the trial completion of PuraPly AM, assessing it in combination with SoC vs SOC alone for the management of non-healing diabetic foot ulcers (DFUs)
The 170-patient trial achieved its 1EP, showing significant wound closure at 12wks., with the company planning to publish the study results soon in a journal
PuraPly AM…
Shots:
The US FDA has granted 510K Clearance to Vantage, a fully disposable, sterile system designed for minimally invasive lumbar decompression procedures
Vantage features a structured “locate, dilate, decompress” workflow with integrated illumination for direct visualization, enabling precise, depth-controlled bone resection while improving procedural consistency & safety
The single-use system eliminates the need for reusable…
Shots:
restor3d has reported the full commercial availability of the Aeros Modular Stem System, a next-generation total ankle replacement platform designed to enhance implant stability, preserve bone, & improve surgical efficiency
Launched with a limited market release, the system enables flexible implant configurations and introduces a modular stem tibial implant that can be placed via…
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…
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…
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…
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…
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…
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…
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…

