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Home » Authors » Shani Alexander

Articles by Shani Alexander

Stimvias URIS neuromodulation system

Stimvia receives MDR certification for neuromodulation system

Aug. 30, 2024
By Shani Alexander
Stimvia s.r.o. recently secured Medical Device Regulation certification for its Uris neuromodulation system to deliver both percutaneous tibial nerve stimulation and peroneal electrical transcutaneous neuromodulation to treat lower urinary tract symptoms.
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Handshake, money, calculator, MA-letters

Siemens to buy Novartis imaging unit

Aug. 28, 2024
By Shani Alexander
Siemens Healthineers AG made a binding offer to Novartis AG, of Basel, Switzerland, to acquire its Advanced Accelerator Applications Molecular Imaging business which includes the European manufacturing and distribution network of diagnostic radiopharmaceuticals for positron emission tomography scans.
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Vitestro automated blood drawing device

Vitestro receives CE mark for automated blood drawing device

Aug. 28, 2024
By Shani Alexander
Vitestro Holding BV received CE marking for its automated blood drawing device which uses artificial intelligence, ultrasound-guided imaging and robotics to ensure accurate and secure blood collection. The device is the first of its kind to achieve CE mark and the company believes it will be transformational for health care.
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HealthCCSng

Nanox software cleared for coronary artery calcification measurement

Aug. 27, 2024
By Shani Alexander
The clearance by the U.S. FDA of Healthccsng V2.0, an artificial intelligence cardiac solution developed by Nano-x Imaging Ltd.’s (Nanox) subsidiary, Nanox.AI, is highly “significant” for the company and will offer “substantial” benefits to cardiology departments by significantly enhancing the detection of coronary artery calcification, Erez Meltzer, Nanox CEO told BioWorld.
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Blue dollar sign on white background

Getinge to acquire Paragonix for $477M

Aug. 23, 2024
By Shani Alexander
Getinge AB agreed to acquire Paragonix Technologies Inc. for $477 million, including upfront and earn out payments. The deal marks Getinge’s entry into the global organ preservation and transportation market, a rapidly advancing field driven by rising transplant volumes, technological innovations and evolving clinical practices.
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Medtronic Percept RC

FDA approves Medtronic Asleep DBS surgery, expanded MRI labeling

Aug. 22, 2024
By Shani Alexander
The U.S. FDA recently granted Medtronic plc approval for its deep brain stimulation (DBS) system to be used to treat Parkinson’s disease or essential tremor while a patient is asleep, under general anesthesia. The approval gives patients another option for DBS therapy which can transform their quality of life, Amaza Reitmeier, vice president and general manager for Medtronic brain modulation, told BioWorld in an interview.
Read More
Blood cells and bacteria

Algodx receives FDA clearance for early sepsis detection software

Aug. 21, 2024
By Shani Alexander
Algodx AB received U.S. FDA 510(k) clearance for its sepsis detection software Navoy CDS. The technology, which analyzes patient data, has the potential to improve patient outcomes as it enables clinicians to detect and treat sepsis earlier.
Read More
Device in heart

Andera at the heart of growing appetite for cardiovascular devices

Aug. 20, 2024
By Shani Alexander
Andera Partners involvement in a string of recent deals in the cardiovascular space demonstrates the ongoing appetite for devices to treat heart diseases, Olivier Litzka, a partner at Andera Partners told BioWorld.
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Clinical data illustration

Caresyntax raises $180M to grow precision surgery platform

Aug. 19, 2024
By Shani Alexander
The $180 million Caresyntax GmbH recently raised in a series C extension round allows the company to accelerate the commercialization and adoption of its precision surgery platform, Bjorn von Siemens, CFO and CBO of Caresyntax told BioWorld.
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Illustration of cryoblation procedure in breast

Icecure's Prosense destroys 100% of breast cancer tumors

Aug. 16, 2024
By Shani Alexander
Icecure Medical Ltd.’s Prosense system demonstrated a 100% success rate in destroying breast cancer tumors that were less than or equal to 25 millimeters, according to a study published in the British Journal of Radiology.
Read More
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