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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Jan. 10, 2023

View Archived Issues
Hospital at home tech2

From multiple remote sensors to integrated delivery of care, making home the preferred site of care

A panel at the J.P. Morgan Healthcare Conference touched on how multiple remote patient monitoring devices and management can be streamlined via machine learning to identify patients who need follow up, in many cases in their homes, increasing value without increasing the burden on already short-staffed health care organizations. The panelists saw technology as a way around a shortage of providers that could both increase access to care and deliver more targeted acute care while also addressing factors in health disparity to prevent development of disease. Read More

Agilent overcomes Thermo Fisher’s Dionex unit in scrum over chromatography patents

Some patent litigation cases don’t require a deep effort to interpret claims, but the litigation between Agilent Technologies Inc., and Dionex Softron GmbH, forced the Court of Appeals for the Federal Circuit to determine whether a written description adequately captures the use of a piston in a liquid chromatograph to avoid nullification of the claim. Read More
Opticyte technology

Opticyte snags FDA breakthrough nod for organ failure monitor

The U.S. FDA has granted Opticyte Inc. a breakthrough device designation for its Cell O2 patient monitor, a noninvasive technology for monitoring patients at risk of organ failure. The device could help to reduce serious illness and deaths by alerting clinicians to patients experiencing organ failure before irreversible damage occurs. Read More

CSI bullish on premarket submission for Innova’s thrombectomy system

Cardiovascular Systems Inc. (CSI) reported the submission by its partner Innova Vascular Inc. of U.S. FDA premarket notification for thrombectomy devices to treat peripheral vascular disease. Already an acknowledge leader in atherectomy technologies, St. Paul, Minn.-based CSI intends to acquire and commercialize each device to expand its technology portfolio to include treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). Read More
Person using COVID-19 antigen test at home

FDA hits COVID test maker for lack of marketing authorization, quality management lapses

U.S. FDA warning letters for medical devices are relatively rare these days, and the Oct. 6, 2022, warning to Empowered Diagnostics LLC of Pompano Beach, Fla., suggests that COVID tests are still front and center where FDA enforcement is concerned. Read More

Appointments and advancements for Jan. 10, 2023

New hires and promotions in the med-tech industry, including: Aptamer Group, Aspen Surgical, Healthy.io, Microtransponder, Nyxoah, Quanterix, Sengenics, Sysmex America, Vizgen, Vygon Group. Read More

Financings for Jan. 10, 2023

Med-tech firms raising money in public or private financings, including: Holmusk, Medix Infusion, Telesair, Veradigm. Read More

In the clinic for Jan. 10, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Diadem, Geneoscopy, Neuroptics, Synchron. Read More

Other news to note for Jan. 10, 2023

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biointellisense, Brainsway, Care.ai, Catheter Precision, Cerveau, Coeus, Dermtech, Foundation Medicine, Fusion Genomics, GE Healthcare, Imactis, Karyopharm, Neuronetics, Organox, Othair, Pear Therapeutics, Prothena, Prothena, Ra Medical Systems, Sophia Genetics, Theranica, Thirona. Read More

Regulatory actions for Jan. 10, 2023

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Act Genomics, Arthrex, Bactiguard, Cellmyx, Inogen, Medalliance, Micronoma. Read More

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