November 15, 2021 — RealView Imaging Ltd. recently received FDA 510(k) clearance for its Holoscope-i holographic system. The system creates spatially accurate, three-dimensional interactive medical holograms, based on data received from standard CT scans and 3D ultrasound systems.


November 15, 2021 — Novartis announced results from a pooled post-hoc analysis of Phase III ORION-9, -10 and -11 trials, exploring the impact of body mass index (BMI) levels on the efficacy and safety of twice-yearly inclisiran (Leqvio).

November 12, 2021 — Penumbra Inc. announced that the CHEETAH clinical study of its Indigo System CAT RX Catheter successfully met the primary endpoint and demonstrated high rates of blood clot removal, blood flow restoration and myocardial perfusion in conjunction with percutaneous coronary intervention (PCI) in patients with high thrombus burden.

November 12, 2021 — Orchestra BioMed Inc. announced multiple presentations of long-term clinical results and ISH subgroup data from the MODERATO II study of BackBeat Cardiac Neuromodulation Therapy in patients with hypertension and an indication for a pacemaker at the 2021 Transcatheter Cardiovascular Therapeutics (TCT) conference.


November 12, 2021 — President Joe Biden today announced his intention to nominate cardiologist Robert Califf, M.D., MACC, for the position of commissioner of food and drugs to lead the U.S. Food and Drug Administration (FDA)


November 10, 2021 — Medtronic presented early data for its self-expanding Intrepid transcatheter mitral valve replacement (TMVR) system in patients with severe, symptomatic mitral valve regurgitation (MR) utilizing the transfemoral access route. It was presented as Late-Breaking Clinical Science at the 2021 Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation.

November 10, 2021 — eMurmur, a technology partner to the global healthcare community, announces the world’s first open software platform for advanced digital auscultation (stethoscope technology) is now available in the U.S. It makes improved screening for heart, lung and bowel health accessible to hardware and telehealth providers throughout the U.S.

November 10, 2021 — Biosensors International Group Ltd., a developer and manufacturer of innovative medical devices, announced the results of the BIO-RISE CHINA study, sponsored by its sister company, JW Medical Systems Ltd. (Shangdong, China). BIO-RISE CHINA is a multi-center, randomized controlled, superiority trial performed in 10 centers across China under the leadership of Prof.

November 10, 2021 — Shockwave Medical a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today unveiled new data confirming the safety and effectiveness of coronary IVL out to one year, a new gender analysis that found similar outcomes between men and women, and an OCT analysis that found consistent acute performance in eccentric, concentric and nodular calcified lesions.

November 10, 2021 — Abbott released new global market research from its Beyond Intervention initiative, the company’s multi-year global research program designed to examine the vascular patient experience from the perspectives of patients, physicians and healthcare leaders.

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