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Home » Authors » Shani Alexander

Articles by Shani Alexander

QP Brain analysis software

Quibim launches QP-Brain software after regulatory clearance

Jan. 17, 2024
By Shani Alexander
Quibim SL recently launched its artificial intelligence (AI)-based software QP-Brain, which is designed to detect early-stage neurodegenerative diseases, after it received U.S. FDA 510(k) clearance, as well as CE and UKCA marks from the EU and U.K. regulators, respectively. QP-Brain quantifies and presents data from patients’ brain images to help clinicians with early diagnosis and treatment strategies for diseases such as Alzheimer’s, multiple sclerosis and dementia.
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Onera STS PSG system head and chest patches

Onera raises €30M for sleep diagnostic test

Jan. 16, 2024
By Shani Alexander
Onera Technologies BV raised €30 million (US$32.7 million) in a series C funding round that will allow the company to accelerate the manufacturing and deployment of its patch-based sleep test system. The funds will also go towards concluding the development of the company’s second-generation polysomnography (PSG) system.
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Medtronic Percept RC

FDA greenlights Medtronic sensing-enabled DBS system

Jan. 12, 2024
By Shani Alexander
Medtronic plc received the greenlight from the U.S. FDA for its latest deep brain stimulation system, the Percept RC. The rechargeable neurostimulator includes the company’s sensing technology which captures data from brain signals and allows for more personalized therapy.
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Pfizer echogo

Ultromics partners with Pfizer on cardiac amyloidosis detection

Jan. 11, 2024
By Shani Alexander
Ultromics Ltd. joined forces with Pfizer Inc. to expedite U.S. FDA clearance of its artificial intelligence (AI)-enhanced platform to aid early diagnosis of cardiac amyloidosis, also known as stiff heart syndrome. The company received FDA breakthrough device designation last year for Echogo Amyloidosis, which uses deep AI to analyze echocardiograms and detect the presence of cardiac amyloidosis, a serious condition often missed during standard heart assessments.
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Medtronic pacemaker

Orchestra bioelectronics tune hypertension in pacemaker patients

Jan. 10, 2024
By Shani Alexander
Orchestra Biomed Holdings Inc. randomized the first patient in the BACKBEAT pivotal study investigating the use of its atrioventricular interval modulation (AVIM) therapy as a treatment for patients with uncontrolled hypertension implanted with a Medtronic plc pacemaker. AVIM therapy is an investigational patented bioelectronic therapy designed to immediately and durably reduce blood pressure.
Read More
3D illustration of liver and photomicrograph showing triglyceride fat accumulated in liver cells.

Boehringer backs £30M study to find new liver disease treatments

Jan. 9, 2024
By Shani Alexander
Boehringer Ingelheim GmbH partnered with Newcastle University and the University of Edinburgh to fund a £30 million (US$38 million) study into liver cirrhosis in a bid to provide scientists with new insights into liver health. The partners hope that the study will not only enhance the understanding of nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH) cirrhosis, but also help identify translational biomarkers using a cutting-edge approach called single-cell RNA sequencing to accelerate the development of future therapies.
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medtronic micra vr2

Medtronic receives CE mark for latest leadless pacemakers and CGM

Jan. 8, 2024
By Shani Alexander
Medtronic plc received CE mark for its latest miniature, leadless pacemakers, the Micra AV2 and Micra VR2. According to the company, they are the world's smallest pacemakers, provide a longer battery life, and are easier to program than previous Micra pacemakers, while maintaining the benefits of their predecessors such as reduced complications compared to traditional pacemakers.
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Coin stacks layered with charts

Cardiomech injects $13M into mitral valve tech

Jan. 5, 2024
By Shani Alexander
Cardiomech AS raised $13 million in fresh capital via a convertible loan agreement that will go towards developing its transcatheter mitral valve chordal repair technology. The round was heavily oversubscribed, indicating investors' expectations that the company’s technology may be a first-line therapy for patients suffering from degenerative mitral regurgitation.
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Renovos Renovite gel and reliable fusion

Renovos wins breakthrough device designation for nanoclay gel

Jan. 4, 2024
By Shani Alexander
Renovos Biologics Ltd. was granted a U.S. FDA breakthrough device designation for its Renovite BMP-2 (bone morphogenetic protein-2) product, which is designed for interbody spinal fusion.
Read More
Roche building

Roche agrees to pay Lumiradx $350M for point-of-care technology

Jan. 3, 2024
By Shani Alexander
Roche Holding AG entered into a definitive agreement to buy Lumiradx Ltd.’s point-of-care technology platform for $350 million. The deal is part of Roche’s effort to transform its point-of-care portfolio and enable more patient-centric health care. For Lumiradx, the sale is the end of a journey to restructure and refocus the company and will result in it being delisted from Nasdaq.
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