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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

July 20, 2023

View Archived Issues
Candida auris

T2 snags three-peat with C. auris test breakthrough device designation

T2 Biosystems Inc. received a third FDA breakthrough device designation with its direct-from-blood molecular diagnostic test for Candida auris. The test joins its T2resistance panel and T2Lyme panel in gaining the breakthrough recognition and the increased access to the FDA that comes with it as the company seeks final approval or clearance. The C. auris test enables identification of the challenging pathogen in three to five hours instead of the several days often required to grow a culture traditionally. Read More

Neura Robotics raises $55M to expand into the US and Japan

Neura Robotics GmbH closed a $55 million funding round that will allow the company to expand its operation into the U.S. and Japan and increase its production infrastructure in Germany amid growing demand. The company, which builds cognitive robots, has an order book which exceeds $450 million. Read More
Neko Body Scan cubicle

Neko Health secures $65M for AI-driven full body scan technology

Neko Health AB reported it has secured $67 million in investment capital to develop its artificial intelligence (AI)-driven full body scanner beyond its home country, Sweden. This series A round was led by Berlin-based Lakestar Advisors GmbH, with participation from Atomico (UK) Partners LLP from London and General Catalyst Group Management LLC from Cambridge, Mass. “Our new concept in body digitization technology, capable of rapidly collecting large amounts of health data, will enable us to identify illness at an early stage and take preventive action,” Hjalmar Nilsonne, CEO and co-founder of Neko Health told BioWorld. Read More

Edge Biologicals, Outset Medical snared by FDA warning letters

U.S. FDA warning letters to device makers seemed to be on pause for a couple of years, but the agency is picking up the pace with two warnings posted July 18. Outset Medical Inc., of San Jose, Calif., was previously known to be the recipient of a warning letter, but Edge Biologicals Inc. of Memphis, Tenn., took in a warning letter that is replete with repeat violations disclosed in 2015 and 2018, as well as a warning letter issued 11 years ago. Read More
Prostate-cancer-cells

Study concludes AI-powered biomarker successfully predicts ADT benefits in fighting prostate cancer

ArteraAI Inc. released data from a study it said validates the first-ever artificial intelligence (AI)-derived biomarker predicting the benefit of androgen deprivation therapy (ADT) for stripping prostate cancer of the testosterone it requires to grow. Read More

Bipartisan HELP preparedness bill inches open door to prizes, not patents

A day after a U.S. House committee, on a party-line vote, advanced two bills to reauthorize emergency preparedness programs, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 17-3 July 20 to send its bipartisan reauthorization of the Pandemic and All Hazards Preparedness Act to the Senate floor with a do-pass recommendation. Read More

Appointments and advancements for July 20, 2023

New hires and promotions in the med-tech industry, including: Mentis, Orasure. Read More

Financings for July 20, 2023

Med-tech firms raising money in public or private financings, including: Siphox. Read More

In the clinic for July 20, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Insightec, Mainstay Medical, Relievant Medsystems. Read More

Other news to note for July 20, 2023

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alivecor, Concertai, Francis Medical, Magnus Medical, Recensmedical, Terarecon, Vial. Read More

Regulatory actions for July 20, 2023

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Mediview, T2. Read More

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